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The Short-term Efficacy of Gastrodia and Uncaria Drink in Treating Hypertension

Primary Purpose

Masked Hypertension

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Gastrodia and Uncaria Drink
Sponsored by
Shanghai Institute of Hypertension
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Masked Hypertension focused on measuring clinical trials, Gastrodia and Uncaria Drink

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Gastrodia and Uncaria Drink

Arm Description

placebo drink, 1 dose at a time, twice a day, duration: 4 weeks

Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks

Outcomes

Primary Outcome Measures

blood pressure

Secondary Outcome Measures

Full Information

First Posted
May 30, 2014
Last Updated
June 4, 2014
Sponsor
Shanghai Institute of Hypertension
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1. Study Identification

Unique Protocol Identification Number
NCT02156024
Brief Title
The Short-term Efficacy of Gastrodia and Uncaria Drink in Treating Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Institute of Hypertension

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of masked hypertensive patients below 70 years. To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Masked Hypertension
Keywords
clinical trials, Gastrodia and Uncaria Drink

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo drink, 1 dose at a time, twice a day, duration: 4 weeks
Arm Title
Gastrodia and Uncaria Drink
Arm Type
Active Comparator
Arm Description
Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
Intervention Type
Drug
Intervention Name(s)
Gastrodia and Uncaria Drink
Other Intervention Name(s)
tianma gouteng drink
Intervention Description
Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
March 1,2015

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Li, doctor
Phone
021-64370045
Ext
663228
Email
liyanshcn@yahoo.com
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Li, doctor
Phone
021-64370045
Ext
663228
Email
liyanshcn@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yan Li, docter

12. IPD Sharing Statement

Citations:
PubMed Identifier
33019798
Citation
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.
Results Reference
derived
PubMed Identifier
26150543
Citation
Wei 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.
Results Reference
derived

Learn more about this trial

The Short-term Efficacy of Gastrodia and Uncaria Drink in Treating Hypertension

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