Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904695
• Other study ID #: 81202846
• Status: Completed
• Phase: Phase 0
• First received: July 14, 2013
• Last updated: September 4, 2016
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.

Description:

Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.

Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.

Research design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure >140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.

Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.

Discussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.

Exclusion Criteria:

• Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy
• Primary Hypertension

Intervention

Drug:
• Herbs
Herbs 180ml by mouth every 12 hours for 8 weeks
• Antihypertensive drugs
Thiazide diuretics and ACE inhibitor and ß-blocker in different dosage determined by the physician for 8 weeks

Locations

Country	Name	City	State
China	Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (1)

Yuwen Y, Liu YQ, Wang YP, Dai JG, Liu DS, Wang YX, Han XJ. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study. J Integr Med. 2015 Mar;13(2):122-8. doi: 10.1016/S2095-4964(15)60162-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Possible side effects and adverse reactions	Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded	2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up	Yes
Primary	Systolic (SBP) and diastolic (DBP) blood pressure reductions		Before treatment, 8 weeks during treatment	No
Secondary	Cardiac event		Before treatment, 24 weeks follow-up	No
Secondary	Death incident		Before treatment, 24 weeks follow-up	No
Secondary	Scores for symptoms and signs		Before treatment, 8 weeks during treatment	No