Status:
COMPLETED
Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study
Lead Sponsor:
Shanghai Institute of Hypertension
Collaborating Sponsors:
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT04035824
Start Date
October 8 2019
End Date
April 24 2024
Last Update
January 7 2025
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025