The Short-term Efficacy of Gastrodia and Uncaria Drink in Treating Hypertension
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of this study is
- 1.To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of masked hypertensive patients below 70 years.
- 2.To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 30, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedJune 6, 2014
June 1, 2014
1 year
May 30, 2014
June 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood pressure
March 1,2015
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo drink, 1 dose at a time, twice a day, duration: 4 weeks
Gastrodia and Uncaria Drink
ACTIVE COMPARATORGastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
Interventions
Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
Eligibility Criteria
You may qualify if:
- age between 18 to 70 years
- didn't use any anti-hypertension drugs within 2 weeks
- stage 1 masked hypertensive patients, which means clinic blood pressure\<140/90 mmHg,however the daytime(8:00-18:00) 24h ambulatory blood pressure between 135/85 and 150/95mmHg
- be willing to participate in the trials and able to finish clinic visit
You may not qualify if:
- secondary hypertension
- be allergic to the clinical trial medicine
- occurrence of stroke, CKD, myocardial infarction within 2 years
- dysfunction of liver or kidney and fundus hemorrhage
- arrhythmia
- ALT, AST, TBL upper the twice of normal range, Scr≥2.0mg/dl, K+≥5.5mmol/L, Urine protein≥2+
- psychiatric disorders
- pregnant, breastfeeding
- other serious conditions in which is not fit for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Related Publications (2)
Zhang DY, Cheng YB, Guo QH, Shan XL, Wei FF, Lu F, Sheng CS, Huang QF, Yang CH, Li Y, Wang JG. Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1821-1830. doi: 10.1161/CIRCULATIONAHA.120.046685. Epub 2020 Oct 6.
PMID: 33019798DERIVEDWei FF, Li Y, Zhang L, Shan XL, Cheng YB, Wang JG, Yang CH, Staessen JA. Persistence of Masked Hypertension in Chinese Patients. Am J Hypertens. 2016 Mar;29(3):326-31. doi: 10.1093/ajh/hpv106. Epub 2015 Jul 6.
PMID: 26150543DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master
Study Record Dates
First Submitted
May 30, 2014
First Posted
June 5, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Last Updated
June 6, 2014
Record last verified: 2014-06