search
Back to results

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

Primary Purpose

Hypertension,Essential

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Songling Xuemaikang Capsules
Lifestyle intervention
Placebo
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential focused on measuring Songling Xuemaikang Capsules, Vascular remodeling, Grade 1 hypertension, Mild hypertension

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences
  • Suzhou Hosptial of Traditional Chinese Medicine
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
  • China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lifestyle intervention + Songling Xuemaikang Capsules

Lifestyle intervention + placebo

Arm Description

Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks

Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks placebo, 3 capsules at a time, three times a day, duration: 12 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
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, Shandong University of Traditional Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT06093932
Brief Title
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
Acronym
ESCIHP
Official Title
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
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, Shandong University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
Songling Xuemaikang Capsules, Vascular remodeling, Grade 1 hypertension, Mild hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention + Songling Xuemaikang Capsules
Arm Type
Experimental
Arm Description
Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks
Arm Title
Lifestyle intervention + placebo
Arm Type
Placebo Comparator
Arm Description
Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks placebo, 3 capsules at a time, three times a day, duration: 12 weeks
Intervention Type
Drug
Intervention Name(s)
Songling Xuemaikang Capsules
Intervention Description
3 capsules at a time, three times a day, duration: 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
everyday, duration: 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 capsules at a time, three times a day, duration: 12 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Secondary Outcome Measure Information:
Title
Change from Baseline in the ba-PWV at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the skin capillary density(SCD) at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Mean 24h PP at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the BP load at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Official PP at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Official SBP at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Official DBP at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Official BP Compliance Rate at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Home SBP at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Home DBP at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks
Description
Proportion= Number of target patients/Total patients
Time Frame
Week 12
Title
Change from Baseline in the CIMT at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12
Title
Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks
Description
Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)
Time Frame
Baseline and Week 4,12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anlu Wang, Doctor
Phone
010-62835342
Email
wwanganlu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiyu Liu, Doctor
Phone
010-18810722937
Email
liuqy9307@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Xu, Prof.
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anlu Wang, Doctor
Phone
010-62835342
Email
wwanganlu@126.com
Facility Name
Suzhou Hosptial of Traditional Chinese Medicine
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongqi Bao, Prof.
Phone
0512-65222220
Email
brq168@126.com
Facility Name
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Lu, Prof.
Phone
0531-68616063
Email
243173005@qq.com
Facility Name
China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigeng Hu, Prof.
Phone
0351-8618099
Email
13835172121@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33019798
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs