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

NCT04035824 | Completed Phase 4

• 1 other identifier: 2018YFC1704902
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypertension

Keywords

Gastrodia and Uncaria; Stage one Hypertension; Liver yang hyperactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in office blood pressure

  4 and 8 weeks

• Change in 24-hour ambulatory systolic blood pressure by stratum

  8 weeks

• Change in 24-hour ambulatory diastolic blood pressure, daytime and nighttime blood pressure

  8 weeks

• Change in home blood pressure

  8 weeks

Study Arms (2)

Gastrodia and Uncaria granule

ACTIVE COMPARATOR

Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd

Drug: Gastrodia and Uncaria granule

Placebo

PLACEBO COMPARATOR

Placebo of Gastrodia and Uncaria granule, Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd

Drug: Placebo of Gastrodia and Uncaria granule

Interventions

Gastrodia and Uncaria granule DRUG

Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months.

Gastrodia and Uncaria granule

Placebo of Gastrodia and Uncaria granule DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• h 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Hypertension: lead
• Ruijin Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

gastrodin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Director of the Center for Epidemiological Studies and Clinical Trials, and Vice Director of the Center for Vascular Evaluations

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: October 8, 2019
• Primary Completion: April 12, 2024
• Study Completion: April 24, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CN (1)