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

Masked Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02156024
• Other study ID #: JDZX2012115
• Status: Recruiting
• Phase: Phase 4
• First received: May 30, 2014
• Last updated: June 4, 2014
• Start date: March 2014

Study information

• Verified date: June 2014
• Source: Shanghai Institute of Hypertension
• Contact: Yan Li, doctor
• Phone: 021-64370045
• Email: liyanshcn[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Masked Hypertension

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Hypertension

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		March 1,2015	Yes