Idiopathic Pulmonary HypertensionNCT07604805
Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension
A study testing Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension and Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone in people with Idiopathic Pulmonary Hypertension, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Hypertension
- What is being tested?
- Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension and Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit.
- 2. Diagnosed with pulmonary arterial hypertension (PAH) classified according to the 2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension, and belonging to one of the following subgroups:
- Subgroup Ⅰ: Idiopathic pulmonary arterial hypertension (IPAH) under the category of arterial pulmonary hypertension
- Subgroup Ⅱ: Pulmonary hypertension secondary to left heart disease (congenital heart disease) 3. World Health Organization (WHO) Functional Class III or IV symptoms at screening.
- 4. Meet all of the following hemodynamic criteria confirmed by right heart catheterization (RHC) at study screening: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg.
- 5. Able to walk a minimum of 100 meters and a maximum of 440 meters during the 6-Minute Walk Test (6MWT) at the screening visit; in addition, participants must demonstrate stable baseline 6MWT performance between the screening visit and the randomization visit.
- 6. Participants with pulmonary hypertension who are either treatment-naïve or currently receiving treatment: for participants who have received prior treatment (defined as having used PAH-targeted therapeutic agents within 4 weeks before screening), mPAP ≥ 25 mmHg and PCWP ≤ 15 mmHg must be confirmed at the randomization visit.
- 7. Able to understand study procedures, willing to comply with study restrictions, and willing and able to provide written informed consent prior to the initiation of all study-related procedures.
Who cannot join
- 1. Meet any of the following criteria: 2. Diagnosed with Group 3 or Group 5 pulmonary hypertension (PH) according to the *2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension*.
- 3. Echocardiogram within 6 months before screening indicates left ventricular ejection fraction (LVEF) ≤ 40%, or clinically significant ischemic mitral or aortic valve disease, or constrictive heart disease as judged by the investigator.
- 4. Presence of 3 or more of the following risk factors for left ventricular dysfunction:
- Body mass index (BMI) ≥ 30 kg/m² at screening visit
- History of essential hypertension
- Diabetes mellitus of any type
Show all 23Show fewer
- History of significant coronary artery disease (CAD) confirmed by any of the following:
- History of myocardial infarction
- History of percutaneous coronary intervention (PCI)
- Angiographic evidence of ≥ 50% stenosis in at least one major coronary artery
- Positive cardiac stress imaging test
- History of coronary artery bypass graft surgery (CABG)
- History of chronic stable angina or unstable angina 5. Uncontrolled systemic arterial hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at randomization visit (Day 1).
- 6. History of long QT syndrome or torsades de pointes ventricular tachycardia. 7. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal (ULN) at screening visit.
- 8. Severe renal impairment: estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² at screening calculated by the CKD-EPI formula.
- 9. Severe hepatic impairment (Child-Pugh Class C) at screening visit, with or without cirrhosis; patients receiving renal dialysis or with a history of renal transplantation.
- 10. Known coagulation defects, including: hereditary or acquired coagulation disorders (factor XII deficiency, factor XIII deficiency), reduced coagulation factor production due to acute or chronic liver disease, impaired coagulation efficiency caused by lupus anticoagulant, disseminated intravascular coagulation (DIC), or anticoagulant factor autoantibodies.
- 11. Evidence or history of major hemorrhage or intracranial hemorrhage. 12. History of increased intracranial pressure. 13. Pregnant or lactating women. 14. Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of any drug, including but not limited to: history of major gastrointestinal surgery deemed clinically significant by the investigator within 12 months before screening (e.g., gastrectomy, gastrointestinal stoma anastomosis, intestinal resection, gastric bypass surgery, gastroenterostomy, or gastric banding), current active inflammatory bowel disease, or history of active inflammatory bowel disease.
- 15. Any surgical or medical condition not specified in the protocol that, in the investigator's opinion, would expose the patient to higher risk due to study participation, or may prevent the patient from complying with study requirements or completing the trial period.
- 16. Patients who are unwilling or unable to safely discontinue current pulmonary arterial hypertension (PAH)-targeted medications during the study as required by the protocol.
- 17. History of any contraindication or hypersensitivity reaction to any study drug or drugs with similar chemical structures.
- 18. History of active substance abuse (including alcohol) within the past 1 year, or patients considered potentially unreliable by the investigator.
- 19. Personnel directly involved in the conduct of this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guagdong, 515000
Xuyu H, Md，PhD, 8613232273712, hexuyu97@126.com
About this study
Official title: Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension: A Prospective, Randomized Controlled Trial
This study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment.
Pulmonary hypertension is a chronic condition that raises blood pressure in the lung arteries, causing symptoms like shortness of breath, tiredness, and difficulty with physical activity. While targeted drug treatments are available, many patients still experience persistent symptoms and reduced quality of life. This study will enroll patients with severe pulmonary hypertension to see if adding Qishen Yiqi Dropping Pills to standard treatment can improve patient outcomes.
Read more
Participants will be randomly assigned to one of two groups: the combination treatment group will receive Qishen Yiqi Dropping Pills plus standard targeted drugs, and the control group will receive standard targeted drugs alone. All participants will be followed for 52 weeks, during which we will regularly assess:
- Changes in daily quality of life
- How far participants can walk in 6 minutes, and their level of breathlessness after the walk
- Changes in heart function and related blood test indicators
- Any side effects or discomfort during treatment The primary goal of this study is to see if the combination treatment can improve patients' exercise capacity and quality of life more effectively than standard treatment alone. We will also monitor the safety of adding Qishen Yiqi Dropping Pills to standard therapy. All study procedures follow ethical regulations, and participants can withdraw from the study at any time without affecting their regular medical care.
Read the detailed description
A single-center, parallel, randomized, controlled trial will be conducted to evaluate the efficacy and safety of Qishen Yiqi Dropping Pills combined with western medicine therapy compared with western medicine therapy alone in Asian patients with pulmonary hypertension. A total of 120 pulmonary hypertension patients aged 18-75 years will be recruited into the study in Guangdong Provincial People's Hospital. After a screening period of no more than 2 weeks, patients will be randomly assigned to the Qishen Yiqi Dropping Pills 0.5g three times daily plus targeted drug therapy group or the targeted drug therapy alone group in a 1:1 ratio. All patients in both groups will receive treatment for 52 weeks, and participants will be followed for 26 weeks after the end of treatment. The primary outcomes are the changes in patients' quality of life score, 6-minute walk distance, and Borg score.
- Conditions
- Idiopathic Pulmonary Hypertension
- Being tested
- Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension, Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone
- Keywords
- idiopathic pulmonary arterial hypertension
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial HypertensionDrug
Experimental Group: Qishen Yiqi Dropping Pills combined with standard PAH-targeted therapy.
Qishen Yiqi Dropping Pills is an NMPA-approved Chinese patent medicine for cardiovascular diseases, each pill is 0.5g, main ingredients include astragalus membranaceus, salvia miltiorrhiza, panax notoginseng and dalbergia odorifera. Administration: 0.5g orally tid after meals.
Targeted therapy follows *2021 Chinese PAH Diagnosis and Treatment Guidelines*, including one or more approved PAH-targeted agents at clinically recommended doses. Total treatment duration: 26weeks.
Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy AloneDrug
Control Group Intervention: Participants in this group receive standard pulmonary arterial hypertension (PAH)-targeted therapy alone, without additional Qishen Yiqi Dropping Pills.
The targeted therapy regimen complies with the *2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension*, including one or more clinically approved PAH-targeted agents (endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, or soluble guanylate cyclase stimulators) at standard recommended doses. The regimen is consistent with the participants' stable pre-enrollment treatment plan, or initiated per the protocol-specified dosing schedule, with no dose adjustment allowed during the study period unless required for safety reasons. The total treatment duration is 26 weeks, identical to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: QSYQ Pills + targeted monotherapy group | Experimental | Patients in this arm will receive a 12-week period of Qishen Yiqi Dropping Pills 0.5g orally three times daily (tid) in combination with targeted monotherapy. Receives: Drug: Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension |
| Active Comparator: targeted monotherapy group | Active comparator | Patients in this arm will receive a 12-week period of targeted monotherapy. Receives: Drug: Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 6-Minute Walk Distance (6MWD) at 52 Weeks
The 6-Minute Walk Test (6MWT) is a standardized, objective measure of functional exercise capacity commonly used in cardiovascular disease populations. Participants will be instructed to walk as far as possible on a flat, 30-meter long corridor for a total duration of 6 minutes, with the total distance covered (in meters) recorded as the 6-Minute Walk Distance (6MWD). The change in 6MWD from baseline to the end of the treatment period will be calculated as the primary efficacy endpoint, with a greater increase indicating better improvement in cardiopulmonary function and exercise tolerance.
Measured: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of treatment)
Change from Baseline in Seattle Angina Questionnaire (SAQ) Score at 52 Weeks
The Seattle Angina Questionnaire (SAQ) is a validated, disease-specific quality of life measure for patients with cardiovascular disease, covering 5 domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each domain score ranges from 0 to 100, with higher scores indicating better health status and less symptom burden. The change in total SAQ score from baseline to the end of follow-up will be calculated as the primary efficacy endpoint.
Measured: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of follow-up)
Change from Baseline in Borg Rating of Perceived Exertion (RPE) Scale Score at 52 Weeks
The Borg Rating of Perceived Exertion (RPE) Scale is a widely used, validated self-report measure of subjective exercise intensity and dyspnea in cardiovascular patient populations. The 6-20 point Borg Scale will be administered immediately after the 6-Minute Walk Test, where participants rate their perceived level of exertion ranging from 6 (no exertion at all) to 20 (maximal exertion). Lower scores indicate less perceived physical exertion and better exercise tolerance. The change in Borg RPE score from baseline to the end of treatment will be calculated as the primary efficacy endpoint.
Measured: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)
Secondary outcomes (4)
Change from Baseline in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Concentration at 52 Weeks
N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a well-validated circulating biomarker for cardiac wall stress, ventricular dysfunction, and cardiovascular disease prognosis, widely used in the management of heart failure, acute coronary syndrome and other cardiovascular conditions.
Fasting venous blood samples will be collected from participants at specified time points, and serum NT-proBNP concentration will be measured using a clinically validated quantitative assay (unit: picograms per milliliter, pg/mL). The change in NT-proBNP concentration from baseline to the end of treatment will be calculated as the primary efficacy endpoint: a greater reduction in NT-proBNP indicates alleviation of cardiac load and better therapeutic effect.
For participants with heart failure, a reduction of ≥30% in NT-proBNP from baseline is generally recognized as a threshold of clinically meaningful improvement.
Measured: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of follow-up)
Change from Baseline in WHO (NYHA) Functional Classification of Cardiac Status at 52 Weeks
The World Health Organization (WHO) recommended New York Heart Association (NYHA) Functional Classification is a widely used, validated clinical scale to assess the severity of heart failure and functional status in patients with cardiovascular disease. The classification grades cardiac function based on the degree of dyspnea and fatigue experienced during daily activities, ranging from Grade I to Grade IV:
- Grade I: No limitation of physical activity; ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations.
- Grade II: Slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in symptoms of fatigue, dyspnea, or palpitations.
- Grade III: Marked limitation of physical activity; comfortable at rest, but less than ordinary activity causes symptoms.
- Grade IV: Unable to carry out any physical activity without symptoms; symptoms of heart failure are present even at rest, and any physical exertion increases discomfort.
T
Measured: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)
Change from Baseline in Systolic Pulmonary Arterial Pressure (sPAP) Measured by Echocardiography at 12 Weeks
Systolic Pulmonary Arterial Pressure (sPAP) is a key hemodynamic parameter reflecting the pressure in the pulmonary artery during cardiac systole, widely used for the diagnosis, severity assessment and prognosis evaluation of pulmonary hypertension, left heart failure, valvular heart disease and other cardiovascular conditions.
sPAP will be measured by transthoracic echocardiography performed by qualified sonographers at specified time points, calculated based on the tricuspid regurgitation jet velocity using the simplified Bernoulli equation, with measurement unit in millimeters of mercury (mmHg). The change in sPAP concentration from baseline to the end of treatment will be calculated as the primary efficacy endpoint: a greater reduction in sPAP indicates alleviation of pulmonary vascular resistance and right ventricular load, as well as better therapeutic effect.
In patients with left heart disease related pulmonary hypertension, a reduction of ≥10 mmHg in sPAP from baseline is gen
Measured: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in Participants Receiving Qishen Yiqi Dropping Pills Combined with Targeted Therapy versus Targeted Therapy Alone
Measured: Baseline (within 7 days before treatment initiation), every 2 weeks during treatment, at the end of treatment (12 weeks), and 30 days after the last dose of study treatment (safety follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 Oct 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XuYu He, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604805
- Sponsor's protocol ID
- KY2023-707
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07604805
- Acronym / sponsor ID
- KY2023-707
- Conditions
- Idiopathic Pulmonary Hypertension
- Keywords
- idiopathic pulmonary arterial hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment.
Pulmonary hypertension is a chronic condition that raises blood pressure in the lung arteries, causing symptoms like shortness of breath, tiredness, and difficulty with physical activity. While targeted drug treatments are available, many patients still experience persistent symptoms and reduced quality of life. This study will enroll patients with severe pulmonary hypertension to see if adding Qishen Yiqi Dropping Pills to standard treatment can improve patient outcomes.
Participants will be randomly assigned to one of two groups: the combination treatment group will receive Qishen Yiqi Dropping Pills plus standard targeted drugs, and the control group will receive standard targeted drugs alone. All participants will be followed for 52 weeks, during which we will regularly assess:
- Changes in daily quality of life
- How far participants can walk in 6 minutes, and their level of breathlessness after the walk
- Changes in heart function and related blood test indicators
- Any side effects or discomfort during treatment The primary goal of this study is to see if the combination treatment can improve patients' exercise capacity and quality of life more effectively than standard treatment alone. We will also monitor the safety of adding Qishen Yiqi Dropping Pills to standard therapy. All study procedures follow ethical regulations, and participants can withdraw from the study at any time without affecting their regular medical care.
Detailed description
A single-center, parallel, randomized, controlled trial will be conducted to evaluate the efficacy and safety of Qishen Yiqi Dropping Pills combined with western medicine therapy compared with western medicine therapy alone in Asian patients with pulmonary hypertension. A total of 120 pulmonary hypertension patients aged 18-75 years will be recruited into the study in Guangdong Provincial People's Hospital. After a screening period of no more than 2 weeks, patients will be randomly assigned to the Qishen Yiqi Dropping Pills 0.5g three times daily plus targeted drug therapy group or the targeted drug therapy alone group in a 1:1 ratio. All patients in both groups will receive treatment for 52 weeks, and participants will be followed for 26 weeks after the end of treatment. The primary outcomes are the changes in patients' quality of life score, 6-minute walk distance, and Borg score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: QSYQ Pills + targeted monotherapy group | Experimental | Drug: Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial HypertensionPatients in this arm will receive a 12-week period of Qishen Yiqi Dropping Pills 0.5g orally three times daily (tid) in combination with targeted monotherapy. |
| Active Comparator: targeted monotherapy group | Active comparator | Drug: Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy AlonePatients in this arm will receive a 12-week period of targeted monotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit.
- 2. Diagnosed with pulmonary arterial hypertension (PAH) classified according to the 2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension, and belonging to one of the following subgroups:
- Subgroup Ⅰ: Idiopathic pulmonary arterial hypertension (IPAH) under the category of arterial pulmonary hypertension
- Subgroup Ⅱ: Pulmonary hypertension secondary to left heart disease (congenital heart disease) 3. World Health Organization (WHO) Functional Class III or IV symptoms at screening.
- 4. Meet all of the following hemodynamic criteria confirmed by right heart catheterization (RHC) at study screening: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg.
Key exclusion criteria (23 listed)
- 1. Meet any of the following criteria: 2. Diagnosed with Group 3 or Group 5 pulmonary hypertension (PH) according to the *2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension*.
- 3. Echocardiogram within 6 months before screening indicates left ventricular ejection fraction (LVEF) ≤ 40%, or clinically significant ischemic mitral or aortic valve disease, or constrictive heart disease as judged by the investigator.
- Body mass index (BMI) ≥ 30 kg/m² at screening visit
- History of essential hypertension
- Diabetes mellitus of any type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial HypertensionExperimental Group: Qishen Yiqi Dropping Pills combined with standard PAH-targeted therapy. Qishen Yiqi Dropping Pills is an NMPA-approved Chinese patent medicine for cardiovascular diseases, each pill is 0.5g, main ingredients include astragalus membranaceus, salvia miltiorrhiza, panax notoginseng and dalbergia odorifera. Administration: 0.5g orally tid after meals. Targeted therapy follows *2021 Chinese PAH Diagnosis and Treatment Guidelines*, including one or more approved PAH-targeted agents at clinically recommended doses. Total treatment duration: 26weeks. | Drug | Active Comparator: QSYQ Pills + targeted monotherapy group |
| Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy AloneControl Group Intervention: Participants in this group receive standard pulmonary arterial hypertension (PAH)-targeted therapy alone, without additional Qishen Yiqi Dropping Pills. The targeted therapy regimen complies with the *2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension*, including one or more clinically approved PAH-targeted agents (endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, or soluble guanylate cyclase stimulators) at standard recommended doses. The regimen is consistent with the participants' stable pre-enrollment treatment plan, or initiated per the protocol-specified dosing schedule, with no dose adjustment allowed during the study period unless required for safety reasons. The total treatment duration is 26 weeks, identical to the experimental group. | Drug | Active Comparator: targeted monotherapy group |
Primary outcome
Change from Baseline in 6-Minute Walk Distance (6MWD) at 52 Weeks
Time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of treatment)
The 6-Minute Walk Test (6MWT) is a standardized, objective measure of functional exercise capacity commonly used in cardiovascular disease populations. Participants will be instructed to walk as far as possible on a flat, 30-meter long corridor for a total duration of 6 minutes, with the total distance covered (in meters) recorded as the 6-Minute Walk Distance (6MWD). The change in 6MWD from baseline to the end of the treatment period will be calculated as the primary efficacy endpoint, with a greater increase indicating better improvement in cardiopulmonary function and exercise tolerance.
Change from Baseline in Seattle Angina Questionnaire (SAQ) Score at 52 Weeks
Time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of follow-up)
The Seattle Angina Questionnaire (SAQ) is a validated, disease-specific quality of life measure for patients with cardiovascular disease, covering 5 domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each domain score ranges from 0 to 100, with higher scores indicating better health status and less symptom burden. The change in total SAQ score from baseline to the end of follow-up will be calculated as the primary efficacy endpoint.
Change from Baseline in Borg Rating of Perceived Exertion (RPE) Scale Score at 52 Weeks
Time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)
The Borg Rating of Perceived Exertion (RPE) Scale is a widely used, validated self-report measure of subjective exercise intensity and dyspnea in cardiovascular patient populations. The 6-20 point Borg Scale will be administered immediately after the 6-Minute Walk Test, where participants rate their perceived level of exertion ranging from 6 (no exertion at all) to 20 (maximal exertion). Lower scores indicate less perceived physical exertion and better exercise tolerance. The change in Borg RPE score from baseline to the end of treatment will be calculated as the primary efficacy endpoint.
4 secondary outcomes
Change from Baseline in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Concentration at 52 Weeks
Time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of follow-up)
Change from Baseline in WHO (NYHA) Functional Classification of Cardiac Status at 52 Weeks
Time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)
Change from Baseline in Systolic Pulmonary Arterial Pressure (sPAP) Measured by Echocardiography at 12 Weeks
Time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in Participants Receiving Qishen Yiqi Dropping Pills Combined with Targeted Therapy versus Targeted Therapy Alone
Time frame: Baseline (within 7 days before treatment initiation), every 2 weeks during treatment, at the end of treatment (12 weeks), and 30 days after the last dose of study treatment (safety follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension and Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone in people with Idiopathic Pulmonary Hypertension, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuyu He, MD, PhD (86136322737312, hexuyu97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 6-Minute Walk Distance (6MWD) at 52 Weeks (time frame: Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.