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

NCT ID: NCT02156024

Last Updated: 2014-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Masked Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Gastrodia and Uncaria Drink

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

Group Type ACTIVE_COMPARATOR

Gastrodia and Uncaria Drink

Intervention Type DRUG

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

Interventions

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Gastrodia and Uncaria Drink

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

Intervention Type DRUG

Other Intervention Names

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tianma gouteng drink

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Institute of Hypertension

OTHER

Sponsor Role lead

Responsible Party

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Cheng Yibang

master

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Li, doctor

Role: CONTACT

021-64370045 ext. 663228

Facility Contacts

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Yan Li, doctor

Role: primary

021-64370045 ext. 663228

References

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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.

Reference Type DERIVED
PMID: 33019798 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26150543 (View on PubMed)

Other Identifiers

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JDZX2012115

Identifier Type: -

Identifier Source: org_study_id

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