Hypertension,EssentialPhase 4ESCIHPNCT06093932

Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial

A Phase 4 study testing Songling Xuemaikang Capsules and Lifestyle intervention in people with Hypertension,Essential, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this study is: 1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension. 2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension. 3. Read more about this study

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Hypertension,Essential
What is being tested?: Songling Xuemaikang Capsules and Lifestyle intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 5 sitesChina
Study dates: 7 Apr 2024to Dec 2027
Phase: Phase 4
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 35 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 35-65 years old, male or female;
Grade 1 essential hypertension;
Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;
Sign the informed consent;

Who cannot join

Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR<60ml/(min·1. 73m2);
Gastrointestinal diseases, which may affect drug absorption;
Be allergic to the clinical trial medicine;
Pregnant or breastfeeding women, men who plan to give birth within half a year;
Combined with other serious primary diseases or malignant tumors;
Hyperlipidemia with or without taking lipid-lowering drugs;

Show all 9Show fewer

Combined with left ventricular hypertrophy, ABI < 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque;
Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes);
Other serious conditions in which is not fit for the study.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anlu Wang, Doctor contact

010-62835342

wwanganlu@126.com

Qiyu Liu, Doctor contact

010-18810722937

liuqy9307@163.com

City, postcode or hospital

Sites recruiting now only

5 sites in 1 country

China5 sites, 5 recruiting

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Anlu Wang, Doctor, 010-62835342, wwanganlu@126.com
Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250013
Feng Lu, Prof., 0531-68616063, 243173005@qq.com
Not yet recruiting
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
Jining, Shandong, 272000
Zhiyang Zhu, MD, 0537-6551859, zhuzhy@usx.edu.cn
Not yet recruiting
Suzhou Hosptial of Traditional Chinese Medicine
Suzhou, Jiangsu, 215002
Rongqi Bao, Prof., 0512-65222220, brq168@126.com
Not yet recruiting
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Taiyuan, Shanxi, 030024
Zhigeng Hu, Prof., 0351-8618099, 13835172121@126.com
Not yet recruiting

Other trials in China

About this study

Official title: Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial

The purpose of this study is:

To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension.
To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension.
To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.

Conditions: Hypertension,Essential
Being tested: Songling Xuemaikang Capsules, Lifestyle intervention, Placebo
Keywords: Songling Xuemaikang Capsules, Vascular remodeling, Grade 1 hypertension, Mild hypertension
Medical subject headings: Essential Hypertension, Vascular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Songling Xuemaikang CapsulesDrug
3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle interventionBehavioural
everyday, duration: 12 weeks
PlaceboDrug
3 capsules at a time, three times a day, duration: 12 weeks

Study groups in NCT06093932
Study group	Role	What they receive
Lifestyle intervention + Songling Xuemaikang Capsules	Experimental	1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks Receives: Drug: Songling Xuemaikang Capsules; Behavioral: Lifestyle intervention
Lifestyle intervention + placebo	Placebo comparator	1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks Receives: Behavioral: Lifestyle intervention; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12

Secondary outcomes (20)

Change from Baseline in the ba-PWV at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Mean 24h PP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the BP load at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Official PP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Official SBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Official DBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Official BP Compliance Rate at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Home SBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Home DBP at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks
Proportion= Number of target patients/Total patients
Measured: Week 12
Change from Baseline in the CIMT at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12
Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Measured: Baseline and Week 4,12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 2024Dec 2027

First posted23 Oct 2023
Study start7 Apr 2024
Primary completionDec 2024 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hypertension,EssentialStudies 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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06093932
Sponsor's protocol ID: 2023XL012-3
Acronym: ESCIHP
Status last verified: Aug 2024
First submitted: 17 Oct 2023
Last updated: 20 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang DY, Cheng YB, Guo QH, Shan XL, Wei FF, Lu F, Sheng CS, Huang QF, Yang CH, Li Y, Wang JG. Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1821-1830. doi: 10.1161/CIRCULATIONAHA.120.046685. Epub 2020 Oct 6.
PubMed 33019798
Liu Q, Yu L, Zhang Z, Zhuang Z, Tian W, Wang A, Xu H. The effects of Songling Xuemaikang capsule on vascular remodeling of stage 1 hypertension: a multicenter, randomized placebo-controlled trial protocol. BMC Complement Med Ther. 2025 Aug 6;25(1):300. doi: 10.1186/s12906-025-05038-y.
PubMed 40770317

Interested in taking part?

Anlu Wang, Doctor

010-62835342

wwanganlu@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT06093932
Acronym / sponsor ID: ESCIHP / 2023XL012-3
Conditions: Hypertension,Essential
Keywords: Songling Xuemaikang Capsules, Vascular remodeling, Grade 1 hypertension, Mild hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
Collaborators: Suzhou Hosptial of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine
Study start: 7 Apr 2024 (actual)
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 23 Oct 2023 (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.

The purpose of this study is:

To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension.
To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension.
To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lifestyle intervention + Songling Xuemaikang Capsules	Experimental	Drug: Songling Xuemaikang Capsules, Behavioral: Lifestyle intervention1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention + placebo	Placebo comparator	Behavioral: Lifestyle intervention, Drug: Placebo1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age between 35-65 years old, male or female;
Grade 1 essential hypertension;
Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;
Sign the informed consent;

Key exclusion criteria (9 listed)

Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR<60ml/(min·1. 73m2);
Gastrointestinal diseases, which may affect drug absorption;
Be allergic to the clinical trial medicine;
Pregnant or breastfeeding women, men who plan to give birth within half a year;
Combined with other serious primary diseases or malignant tumors;

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
Songling Xuemaikang Capsules3 capsules at a time, three times a day, duration: 12 weeks	Drug	Lifestyle intervention + Songling Xuemaikang Capsules
Lifestyle interventioneveryday, duration: 12 weeks	Behavioural	Lifestyle intervention + Songling Xuemaikang Capsules, Lifestyle intervention + placebo
Placebo3 capsules at a time, three times a day, duration: 12 weeks	Drug	Lifestyle intervention + placebo

Primary outcome

Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
Time frame: Baseline and Week 4,12
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

20 secondary outcomes

Change from Baseline in the ba-PWV at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Mean 24h PP at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the BP load at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Official PP at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Official SBP at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Official DBP at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Official BP Compliance Rate at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Home SBP at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Home DBP at 4,12 weeks
Time frame: Baseline and Week 4,12
Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks
Time frame: Week 12
Change from Baseline in the CIMT at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks
Time frame: Baseline and Week 4,12
Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks
Time frame: Baseline and Week 4,12

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 20 Aug 2024.
Background: PubMed 33019798Zhang DY, Cheng YB, Guo QH, Shan XL, Wei FF, Lu F, Sheng CS, Huang QF, Yang CH, Li Y, Wang JG. Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1821-1830. doi: 10.1161/CIRCULATIONAHA.120.046685. Epub 2020 Oct 6.
Derived from this study: PubMed 40770317Liu Q, Yu L, Zhang Z, Zhuang Z, Tian W, Wang A, Xu H. The effects of Songling Xuemaikang capsule on vascular remodeling of stage 1 hypertension: a multicenter, randomized placebo-controlled trial protocol. BMC Complement Med Ther. 2025 Aug 6;25(1):300. doi: 10.1186/s12906-025-05038-y.
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.

Anlu Wang, Doctor contact

010-62835342

wwanganlu@126.com

Qiyu Liu, Doctor contact

010-18810722937

liuqy9307@163.com

Hao Xu, Prof. study chair

Xiyuan Hospital of China Academy of Chinese Medical Sciences

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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 Anlu Wang, Doctor (010-62835342, wwanganlu@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 the Mean 24h Systolic Blood Pressure at 4,12 weeks (time frame: Baseline and Week 4,12). 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 NCT06093932, which also lists 2 linked publications.

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 20 Aug 2024.