Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
ESCIHP
1 other identifier
interventional
100
1 country
5
Brief 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.To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2024
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
April 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedAugust 20, 2024
August 1, 2024
8 months
October 17, 2023
August 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline and Week 4,12
Secondary Outcomes (20)
Change from Baseline in the ba-PWV at 4,12 weeks
Baseline and Week 4,12
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
Baseline and Week 4,12
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
Baseline and Week 4,12
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
Baseline and Week 4,12
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
Baseline and Week 4,12
- +15 more secondary outcomes
Study Arms (2)
Lifestyle intervention + Songling Xuemaikang Capsules
EXPERIMENTAL1. 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 COMPARATOR1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks
Interventions
3 capsules at a time, three times a day, duration: 12 weeks
everyday, duration: 12 weeks
3 capsules at a time, three times a day, duration: 12 weeks
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Scienceslead
- China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospitalcollaborator
- Suzhou Hosptial of Traditional Chinese Medicinecollaborator
- China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospitalcollaborator
- Shandong University of Traditional Chinese Medicinecollaborator
Study Sites (5)
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
Suzhou Hosptial of Traditional Chinese Medicine
Suzhou, Jiangsu, 215002, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250013, China
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
Jining, Shandong, 272000, China
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Taiyuan, Shanxi, 030024, China
Related Publications (2)
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.
PMID: 33019798BACKGROUNDLiu 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.
PMID: 40770317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hao Xu, Prof.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2023
First Posted
October 23, 2023
Study Start
April 7, 2024
Primary Completion
December 1, 2024
Study Completion (Estimated)
December 1, 2027
Last Updated
August 20, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share