Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Shanghai Institute of Hypertension
Collaborators:
Ruijin Hospital Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai General Hospital, Shanghai Jiaotong University School of Medicine Shanghai Ruijin Hospital North, Shanghai Jiaotong University School of Medicine