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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04035824
• Other study ID #: 2018YFC1704902
• Status: Recruiting
• Phase: Phase 4
• Start date: October 8, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2021
• Source: Shanghai Institute of Hypertension
• Contact: Yan Li, MD, PhD
• Phone: +8621-64370045
• Email: liyanshcn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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 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.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Institute of Hypertension	Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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