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

Hypertension,Essential Clinical Trial

— ESCIHP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093932
• Other study ID #: 2023XL012-3
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Anlu Wang, Doctor
• Phone: 010-62835342
• Email: wwanganlu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Drug:
• Songling Xuemaikang Capsules
3 capsules at a time, three times a day, duration: 12 weeks

Behavioral:
• Lifestyle intervention
everyday, duration: 12 weeks

Drug:
• Placebo
3 capsules at a time, three times a day, duration: 12 weeks

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing
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	Suzhou Hosptial of Traditional Chinese Medicine	Suzhou	Jiangsu
China	China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital	Taiyuan	Shanxi

Sponsors (5)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital, China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital, Shandong University of Traditional Chinese Medicine, Suzhou Hosptial of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in the ba-PWV at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	Change from Baseline in the Mean 24h PP at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	Change from Baseline in the BP load at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	Change from Baseline in the Official PP at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	Change from Baseline in the Official SBP at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	Change from Baseline in the Official DBP at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	Change from Baseline in the Home SBP at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	Change from Baseline in the Home DBP at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks	Proportion= Number of target patients/Total patients	Week 12
Secondary	Change from Baseline in the CIMT at 4,12 weeks	Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12
Secondary	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)	Baseline and Week 4,12