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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension,Essential
• Intervention / Treatment: Drug: Songling Xuemaikang Capsules; Behavioral: Lifestyle intervention; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anlu Wang, Doctor; Phone Number: 010-62835342; Email: wwanganlu@126.com
• Study Contact Backup: Name: Qiyu Liu, Doctor; Phone Number: 010-18810722937; Email: liuqy9307@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle intervention + Songling Xuemaikang Capsules; Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks; Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks	Drug: Songling Xuemaikang Capsules; 3 capsules at a time, three times a day, duration: 12 weeks; Behavioral: Lifestyle intervention; everyday, duration: 12 weeks
Placebo Comparator: Lifestyle intervention + placebo; Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks; placebo, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Shandong University of Traditional Chinese Medicine; China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital; Suzhou Hosptial of Traditional Chinese Medicine; China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
• Investigators: Study Chair: Hao Xu, Prof., Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Mild hypertension; Songling Xuemaikang Capsules; Vascular remodeling; Grade 1 hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: 2023XL012-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No