HypertensionPhase 4NCT05521282
The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension
A Phase 4 study testing Treatment group in people with Hypertension and Medicine, Chinese Traditional, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Research purpose: This study was a multicenter, randomized, double-blind, placebo-controlled, post-marketing clinical study in Chinese patients with essential hypertension to evaluate the efficacy and safety of Qianglidingxuan tablets(QLT) in the treatment of blood pressure in patients with mild to moderate essential… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Medicine, Chinese Traditional
- What is being tested?
- Treatment group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2021to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Men and women aged 18-75 years.
- Patients diagnosed as essential hypertension with clinical grade 1-2.
- Diagnosis of hyperactivity of liver Yang upper syndrome by TCM syndrome differentiation.
- Patients signed the informed consent with good compliance and could cooperate with the follow-up and review.
Who cannot join
- Secondary hypertension: renal hypertension (renovascular hypertension, renal parenchymal hypertension), pheochromocytoma, primary aldosteronism, Cushing syndrome, abdominal aortic coarctation, etc.
- Coronary atherosclerotic heart disease, acute attack of chronic heart failure, malignant arrhythmia, valvular heart disease, cardiomyopathy and other serious cardiovascular diseases.
- Acute cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage.
- Severe psychological disorder, intellectual disability or language disorder, resulting in inability to fully cooperate with the study and inability to complete the study.
- Any laboratory test index before screening met the following criteria: admission liver and kidney function indicated that ALT, AST > 1.5 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value (refer to the laboratory normal range of the research center); Other clinically significant laboratory abnormalities that were deemed unsuitable for enrollment by the investigator.
- Allergic constitution or allergic to strong fixed glare tablets, excipients or similar ingredients of the trial drug.
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- Suspected or with a history of alcohol or drug abuse.
- Pregnant, lactating women or those who plan to get pregnant recently or are unwilling to use contraceptive measures;.
- Patients who had participated in other clinical trials within 3 months before enrollment.
- Patients deemed by the investigator to be ineligible for enrollment in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, 100053
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Qianglidingxuan Tablets in the Treatment of Mild to Moderate Essential Hypertension With Hyperactivity of Liver Yang
Research purpose: This study was a multicenter, randomized, double-blind, placebo-controlled, post-marketing clinical study in Chinese patients with essential hypertension to evaluate the efficacy and safety of Qianglidingxuan tablets(QLT) in the treatment of blood pressure in patients with mild to moderate essential hypertension.
- Subject: Patients diagnosed as essential hypertension with clinical grade 1-2.
- Interventions: ①Basic treatment plan:Patients in both groups were required to have a low-salt, low-fat diet, quit smoking, limit alcohol, eat more vegetables, moderate exercise, control body weight, and amlodipine besylate tablets (5mg, QD). ②Treatment group: Based on the basic treatment, QLT was given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. ③Control group: Based on basic treatment, QLT mimetic were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
- Treatment and follow-up cycle: Patients in both groups were treated for 12 weeks and followed up to the end of 48th week after treatment.
- Provisions of concurrent treatment: Any combined treatment used during the study should be recorded in the CRF, including drug name (generic name/trade name), starting time, administration dose, method of administration, termination time, indication, etc
- Efficacy evaluation: ①Primary outcome measure: the change from baseline in office blood pressure after 12 weeks of treatment. ②Secondary efficacy indicators: 24-hour ambulatory blood pressure, heart rate, blood lipids, homocysteine, CRP, baPWV. TCM syndromes (including vertigo, headache, impatience and irritability, red face, red eyes, dry mouth, bitter mouth, tinnitus, insomnia, multiple dreams, constipation, urination, etc.) ③Safety indicators: adverse events, vital signs, physical examination, laboratory examination
- Statistics:
SAS® 9.4 was used for all statistical analyses.
- Conditions
- Hypertension, Medicine, Chinese Traditional
- Being tested
- Treatment group
- Keywords
- Hypertension, Qianglidingxuan tablet, Traditional Chinese medicine, Randomized controlled trial, Chinese patent medicine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupDrug
Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
Qianglidingxuan Tablets:
Specifications: 60 tablets per bottle; Storage: airtight, moisture-proof; Active ingredients:Gastrodia elata, Eucommia ulmoides, wild chrysanthemum, Eucommia ulmoides leaves, Chuanxiong; Manufacturer: Shaanxi Hanwang Pharmaceutical Co., LTD. Receives: Drug: Treatment group |
| Control group | Placebo comparator | Based on basic treatment, Qianglidingxuan Tablets mimetics were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
Qianglidingxuan Tablets mimetics:
Specifications: 60 tablets per bottle; Storage: airtight, moisture-proof; Active ingredients:NA; Manufacturer: Shaanxi Hanwang Pharmaceutical Co., LTD. Receives: Drug: Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinic blood pressure
Changes in systolic and diastolic blood pressure from baseline to follow up
Measured: Baseline, month 4, month 12
Secondary outcomes (6)
24-hour ambulatory blood pressure
Changes in daytime systolic BP, daytime diastolic blood pressure, nighttime systolic blood pressure, nighttime diastolic blood pressure, 24h mean systolic blood pressure, and 24h mean diastolic blood pressure from baseline to follow up
Measured: Baseline, month 4, month 12
Heart rate
Changes in heart rate from baseline to follow up
Measured: Baseline, month 4, month 12
Blood lipids
Changes in blood lipids（triglyceride, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol）from baseline to follow up
Measured: Baseline, month 4, month 12
BMI
Changes in BMI from baseline to follow up
Measured: Baseline, month 4, month 12
Homocysteine
Changes in homocysteine from baseline to follow up
Measured: Baseline, month 4, month 12
C reactive protein
Changes in C reactive protein from baseline to follow up
Measured: Baseline, month 4, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start9 Mar 2021
- Primary completion3 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Chinese Medicine
- Responsible party
- Principal investigator, kuiwu Yao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521282
- Sponsor's protocol ID
- QLDXP-202002
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin J, Wang Q, Zhong D, Zhang J, Yuan T, Wu H, Li B, Li S, Xie X, An D, Deng Y, Xian S, Xiong X, Yao K. Efficacy and safety of Qiangli Dingxuan tablet combined with amlodipine besylate for essential hypertension: a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Front Pharmacol. 2023 Jul 10;14:1225529. doi: 10.3389/fphar.2023.1225529. eCollection 2023.
PubMed 37492087
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Qianglidingxuan Tablets in the Treatment of Mild to Moderate Essential Hypertension With Hyperactivity of Liver Yang
- ClinicalTrials.gov ID
- NCT05521282
- Acronym / sponsor ID
- QLDXP-202002
- Conditions
- Hypertension, Medicine, Chinese Traditional
- Keywords
- Hypertension, Qianglidingxuan tablet, Traditional Chinese medicine, Randomized controlled trial, Chinese patent medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Chinese Medicine
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Aug 2022 (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.
Research purpose: This study was a multicenter, randomized, double-blind, placebo-controlled, post-marketing clinical study in Chinese patients with essential hypertension to evaluate the efficacy and safety of Qianglidingxuan tablets(QLT) in the treatment of blood pressure in patients with mild to moderate essential hypertension.
- Subject: Patients diagnosed as essential hypertension with clinical grade 1-2.
- Interventions: ①Basic treatment plan:Patients in both groups were required to have a low-salt, low-fat diet, quit smoking, limit alcohol, eat more vegetables, moderate exercise, control body weight, and amlodipine besylate tablets (5mg, QD). ②Treatment group: Based on the basic treatment, QLT was given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. ③Control group: Based on basic treatment, QLT mimetic were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
- Treatment and follow-up cycle: Patients in both groups were treated for 12 weeks and followed up to the end of 48th week after treatment.
- Provisions of concurrent treatment: Any combined treatment used during the study should be recorded in the CRF, including drug name (generic name/trade name), starting time, administration dose, method of administration, termination time, indication, etc
- Efficacy evaluation: ①Primary outcome measure: the change from baseline in office blood pressure after 12 weeks of treatment. ②Secondary efficacy indicators: 24-hour ambulatory blood pressure, heart rate, blood lipids, homocysteine, CRP, baPWV. TCM syndromes (including vertigo, headache, impatience and irritability, red face, red eyes, dry mouth, bitter mouth, tinnitus, insomnia, multiple dreams, constipation, urination, etc.) ③Safety indicators: adverse events, vital signs, physical examination, laboratory examination
- Statistics:
SAS® 9.4 was used for all statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Treatment groupBased on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. Qianglidingxuan Tablets: Specifications: 60 tablets per bottle; Storage: airtight, moisture-proof; Active ingredients:Gastrodia elata, Eucommia ulmoides, wild chrysanthemum, Eucommia ulmoides leaves, Chuanxiong; Manufacturer: Shaanxi Hanwang Pharmaceutical Co., LTD. |
| Control group | Placebo comparator | Drug: Treatment groupBased on basic treatment, Qianglidingxuan Tablets mimetics were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. Qianglidingxuan Tablets mimetics: Specifications: 60 tablets per bottle; Storage: airtight, moisture-proof; Active ingredients:NA; Manufacturer: Shaanxi Hanwang Pharmaceutical Co., LTD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18-75 years.
- Patients diagnosed as essential hypertension with clinical grade 1-2.
- Diagnosis of hyperactivity of liver Yang upper syndrome by TCM syndrome differentiation.
- Patients signed the informed consent with good compliance and could cooperate with the follow-up and review.
Key exclusion criteria (10 listed)
- Secondary hypertension: renal hypertension (renovascular hypertension, renal parenchymal hypertension), pheochromocytoma, primary aldosteronism, Cushing syndrome, abdominal aortic coarctation, etc.
- Coronary atherosclerotic heart disease, acute attack of chronic heart failure, malignant arrhythmia, valvular heart disease, cardiomyopathy and other serious cardiovascular diseases.
- Acute cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage.
- Severe psychological disorder, intellectual disability or language disorder, resulting in inability to fully cooperate with the study and inability to complete the study.
- Any laboratory test index before screening met the following criteria: admission liver and kidney function indicated that ALT, AST > 1.5 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value (refer to the laboratory normal range of the research center); Other clinically significant laboratory abnormalities that were deemed unsuitable for enrollment by the investigator.
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 |
|---|---|---|
| Treatment groupBased on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. | Drug | Control group, Treatment group |
Primary outcome
Clinic blood pressure
Time frame: Baseline, month 4, month 12
Changes in systolic and diastolic blood pressure from baseline to follow up
6 secondary outcomes
24-hour ambulatory blood pressure
Time frame: Baseline, month 4, month 12
Heart rate
Time frame: Baseline, month 4, month 12
Blood lipids
Time frame: Baseline, month 4, month 12
BMI
Time frame: Baseline, month 4, month 12
Homocysteine
Time frame: Baseline, month 4, month 12
C reactive protein
Time frame: Baseline, month 4, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 37492087Lin J, Wang Q, Zhong D, Zhang J, Yuan T, Wu H, Li B, Li S, Xie X, An D, Deng Y, Xian S, Xiong X, Yao K. Efficacy and safety of Qiangli Dingxuan tablet combined with amlodipine besylate for essential hypertension: a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Front Pharmacol. 2023 Jul 10;14:1225529. doi: 10.3389/fphar.2023.1225529. eCollection 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment group in people with Hypertension and Medicine, Chinese Traditional, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 30 Aug 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinic blood pressure (time frame: Baseline, month 4, month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521282, which also lists 1 linked publication.
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 30 Aug 2022.