Back to results

Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Gastrodia and Uncaria granule

Placebo of Gastrodia and Uncaria granule

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Gastrodia and Uncaria, Stage one Hypertension, Liver yang hyperactivity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female sex, aged 18-80 years.
Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks.
Office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmHg, and diastolic blood pressure <100 mmHg.
24h ambulatory mean systolic blood pressure >= 130mmHg.
Agreed to participant, able to join follow-up and to come to hospital at each visit.
Signed informed consent.

Exclusion Criteria:

Secondary hypertension, confirmed or suspected.
Failed at ambulatory blood pressure monitoring: effective reading < 70%, or the number of awakening BP reading <20, or sleep time BP reading <7.
Taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy.
Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months.
Having a history of atrial fibrillation or frequent arrhythmia.
Having abnormal lab test results: liver function (ALT, AST, TBL) ≥ 2 times the upper normal limit, or serum creatinine ≥ 176umol/L, or serum potassium ≥ 5.5mmol/L.
Pregnant or breastfeeding (for females).
Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors.
Possible poor compliance with the research process.

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gastrodia and Uncaria granule

Placebo

Arm Description

Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd

Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd

Outcomes

Primary Outcome Measures

Change in 24-hour ambulatory systolic blood pressure

The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between treatment and control group

Secondary Outcome Measures

Change in office blood pressure

The difference of change of office systolic and diastolic blood pressure between treatment and control group

Change in 24-hour ambulatory systolic blood pressure by stratum

The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between liver yang hyperactivity and liver yang non-hyperactivity stratum

Change in 24-hour ambulatory diastolic blood pressure, daytime and nighttime blood pressure

The difference of blood pressure change of 24-hour mean ambulatory diastolic, daytime and nighttime systolic and diastolic between treatment and control group.

Change in home blood pressure

Difference of change of home systolic and diastolic blood pressure after 8-week treatment between treatment and control group.

Full Information

NCT ID

NCT04035824

First Posted

July 24, 2019

Last Updated

September 27, 2021

Sponsor

Shanghai Institute of Hypertension

Collaborators

Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04035824

Brief Title

Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study

Official Title

Evidence-based Optimization of Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: a Multi-center, Randomized, Double-blind, Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 8, 2019 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Institute of Hypertension

Collaborators

Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Gastrodia and Uncaria Recipe is a well-known effective prescription in Traditional Chinese Medicine (TCM) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. However, it lacks consolidated evidence by multi-center randomized controlled trials. The hypothesis of this study is that Gastrodia and Uncaria granule may have significant anti-hypertensive effect on patients with stage-one hypertension and liver-yang hyperactivity syndrome than placebo. This study is a randomized, controlled, multi-center, double-blind clinical trial. This study aims to recruit 500 hypertension patients who 1) are untreated or taking anti-hypertensive medicine for at least two weeks and 2) have an office systolic blood pressure of 140-159 mmHg, an office diastolic blood pressure of <100 mmHg, and a 24-hour ambulatory mean systolic blood pressure of >=130 mmHg. The patients will be stratified according to center, sex, and the TCM type of liver yang hyperactivity/ liver yang non-hyperactivity, and are then randomly assigned to the treatment of Gastrodia and Uncaria granules or placebo for 2 months. The blood pressure lowering effect is evaluated by 24-hour ambulatory systolic blood pressure (primary outcome) / diastolic blood pressure, as well as by home and office blood pressures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Gastrodia and Uncaria, Stage one Hypertension, Liver yang hyperactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastrodia and Uncaria granule

Arm Type

Active Comparator

Arm Description

Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd

Intervention Type

Drug

Intervention Name(s)

Gastrodia and Uncaria granule

Intervention Description

Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months.

Intervention Type

Drug

Intervention Name(s)

Placebo of Gastrodia and Uncaria granule

Intervention Description

Patients allocated to the control group take 10g of placebo of Gastrodia and Uncaria granule each time, twice per day, and for two months. The placebo has similar appearance and smell to genuine drug but has no effective anti-hypertensive agents.

Primary Outcome Measure Information:

Title

Change in 24-hour ambulatory systolic blood pressure

Description

The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between treatment and control group

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in office blood pressure

Description

The difference of change of office systolic and diastolic blood pressure between treatment and control group

Time Frame

4 and 8 weeks

Title

Change in 24-hour ambulatory systolic blood pressure by stratum

Description

The difference of change of 24h ambulatory systolic blood pressure after 8-week treatment between liver yang hyperactivity and liver yang non-hyperactivity stratum

Time Frame

8 weeks

Title

Change in 24-hour ambulatory diastolic blood pressure, daytime and nighttime blood pressure

Description

The difference of blood pressure change of 24-hour mean ambulatory diastolic, daytime and nighttime systolic and diastolic between treatment and control group.

Time Frame

8 weeks

Title

Change in home blood pressure

Description

Difference of change of home systolic and diastolic blood pressure after 8-week treatment between treatment and control group.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female sex, aged 18-80 years. Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks. Office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmHg, and diastolic blood pressure <100 mmHg. 24h ambulatory mean systolic blood pressure >= 130mmHg. Agreed to participant, able to join follow-up and to come to hospital at each visit. Signed informed consent. Exclusion Criteria: Secondary hypertension, confirmed or suspected. Failed at ambulatory blood pressure monitoring: effective reading < 70%, or the number of awakening BP reading <20, or sleep time BP reading <7. Taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy. Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months. Having a history of atrial fibrillation or frequent arrhythmia. Having abnormal lab test results: liver function (ALT, AST, TBL) ≥ 2 times the upper normal limit, or serum creatinine ≥ 176umol/L, or serum potassium ≥ 5.5mmol/L. Pregnant or breastfeeding (for females). Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors. Possible poor compliance with the research process.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Li, MD, PhD

Phone

+8621-64370045

Ext

663201

liyanshcn@163.com

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Li, doctor

Phone

021-64370045

Ext

663228

liyanshcn@yahoo.com

First Name & Middle Initial & Last Name & Degree

Yan Li, docter

12. IPD Sharing Statement

Learn more about this trial

Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study

We'll reach out to this number within 24 hrs