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

Sponsor
Shanghai Institute of Hypertension (Other)
Overall Status
Unknown status
CT.gov ID
NCT02156024
Collaborator
(none)
400
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gastrodia and Uncaria Drink
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Mar 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. blood pressure [March 1,2015]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Institute of Hypertension

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cheng Yibang, master, Shanghai Institute of Hypertension
    ClinicalTrials.gov Identifier:
    NCT02156024
    Other Study ID Numbers:
    • JDZX2012115
    First Posted:
    Jun 5, 2014
    Last Update Posted:
    Jun 6, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Cheng Yibang, master, Shanghai Institute of Hypertension
    clinical trials
    Gastrodia and Uncaria Drink
    Additional relevant MeSH terms:
    Hypertension
    Masked Hypertension

    Study Results

    No Results Posted as of Jun 6, 2014