NCT02156024

Brief Summary

The purpose of this study is

  1. 1.To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of masked hypertensive patients below 70 years.
  2. 2.To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

May 30, 2014

Last Update Submit

June 4, 2014

Conditions

Keywords

clinical trialsGastrodia and Uncaria Drink

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    March 1,2015

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Gastrodia and Uncaria Drink

ACTIVE COMPARATOR

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

Drug: Gastrodia and Uncaria Drink

Interventions

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

Also known as: tianma gouteng drink
Gastrodia and Uncaria Drink

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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.

  • 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.

MeSH Terms

Conditions

Masked Hypertension

Interventions

gastrodin

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yan Li, doctor

CONTACT

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

Locations