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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: Gastrodia and Uncaria granule; Drug: Placebo of Gastrodia and Uncaria granule

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female sex, aged 18-80 years.
2. Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks.
3. 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.
4. 24h ambulatory mean systolic blood pressure >= 130mmHg.
5. Agreed to participant, able to join follow-up and to come to hospital at each visit.
6. Signed informed consent.

Exclusion Criteria:

1. Secondary hypertension, confirmed or suspected.
2. Failed at ambulatory blood pressure monitoring: effective reading < 70%, or the number of awakening BP reading <20, or sleep time BP reading <7.
3. 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.
4. Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months.
5. Having a history of atrial fibrillation or frequent arrhythmia.
6. 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.
7. Pregnant or breastfeeding (for females).
8. 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.
9. Possible poor compliance with the research process.

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
Active Comparator: Gastrodia and Uncaria granule; Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd	Drug: Gastrodia and Uncaria granule; Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months.
Placebo Comparator: Placebo; Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd	Drug: Placebo of Gastrodia and Uncaria granule; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in office blood pressure	The difference of change of office systolic and diastolic blood pressure between treatment and control group	4 and 8 weeks
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	8 weeks
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.	8 weeks
Change in home blood pressure	Difference of change of home systolic and diastolic blood pressure after 8-week treatment between treatment and control group.	8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Institute of Hypertension
• Collaborators: Ruijin Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Gastrodia and Uncaria; Stage one Hypertension; Liver yang hyperactivity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2018YFC1704902

Drug and device information, study documents

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