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

June 4, 2014 updated by: Cheng Yibang, Shanghai Institute of Hypertension

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
placebo drink, 1 dose at a time, twice a day, duration: 4 weeks
ACTIVE_COMPARATOR: Gastrodia and Uncaria Drink
Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
Drug: Gastrodia and Uncaria Drink
Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
Other Names:
  • tianma gouteng drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: March 1,2015
March 1,2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Hypertension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (ESTIMATE)

June 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JDZX2012115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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