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

NCT ID: NCT01904695

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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.

Conditions

Primary Hypertension; Hypertension, Resistant to Conventional Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antihypertensive drugs & Herbs

Thiazide diuretics and ACE inhibitor and β-blocker \& Herbs for 8 weeks

Group Type: EXPERIMENTAL

Herbs

Intervention Type: DRUG

Herbs 180ml by mouth every 12 hours for 8 weeks

Antihypertensive drugs

Intervention Type: DRUG

Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks

Antihypertensive drugs

Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks

Group Type: ACTIVE_COMPARATOR

Antihypertensive drugs

Intervention Type: DRUG

Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks

Interventions

Herbs

Herbs 180ml by mouth every 12 hours for 8 weeks

Intervention Type: DRUG

Antihypertensive drugs

Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks

Intervention Type: DRUG

Other Intervention Names

recipe of removing both phlegem and blood stasis; Thiazide diuretics and ACE inhibitor and β-blocker

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ya YUWEN

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ya YUWEN, PhD

Role: STUDY_DIRECTOR

China Academy of Chinese Medical Sciences

Locations

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 25797643 (View on PubMed)

Other Identifiers

81202846

Identifier Type: -

Identifier Source: org_study_id