A Phase 4 interventional study of Gastrodia and Uncaria granule and Placebo of Gastrodia and Uncaria granule in Hypertension, sponsored by Shanghai Institute of Hypertension. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Shanghai Institute of Hypertension · Phase 4, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 605 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd
Drug: Gastrodia and Uncaria granule
Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd
Drug: Placebo of 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.
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.
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
Time frame: 8 weeks
Change in office blood pressure
The difference of change of office systolic and diastolic blood pressure between treatment and control group
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Institute of Hypertension