Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
NCT ID: NCT06093932
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-04-07
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lifestyle intervention + Songling Xuemaikang Capsules
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
Songling Xuemaikang Capsules
3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention
everyday, duration: 12 weeks
Lifestyle intervention + placebo
1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks
2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention
everyday, duration: 12 weeks
Placebo
3 capsules at a time, three times a day, duration: 12 weeks
Interventions
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Songling Xuemaikang Capsules
3 capsules at a time, three times a day, duration: 12 weeks
Lifestyle intervention
everyday, duration: 12 weeks
Placebo
3 capsules at a time, three times a day, duration: 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Grade 1 essential hypertension;
* Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;
* Sign the informed consent;
Exclusion Criteria
* 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.
35 Years
65 Years
ALL
No
Sponsors
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China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
UNKNOWN
Suzhou Hosptial of Traditional Chinese Medicine
UNKNOWN
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
UNKNOWN
Shandong University of Traditional Chinese Medicine
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Hao Xu, Prof.
Role: STUDY_CHAIR
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Locations
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Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Suzhou Hosptial of Traditional Chinese Medicine
Suzhou, Jiangsu, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
Jining, Shandong, China
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2023XL012-3
Identifier Type: -
Identifier Source: org_study_id
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