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

Early Phase 1CompletedNCT01904695

China Academy of Chinese Medical Sciences192 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

Primary Hypertension Hypertension, Resistant to Conventional Therapy

Interventions

HerbsDRUG

Herbs 180ml by mouth every 12 hours for 8 weeks

Antihypertensive drugsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Systolic (SBP) and diastolic (DBP) blood pressure reductions

Time frame: Before treatment, 8 weeks during treatment

Secondary Outcomes

Cardiac event

Time frame: Before treatment, 24 weeks follow-up

Death incident

Time frame: Before treatment, 24 weeks follow-up

Scores for symptoms and signs

Time frame: Before treatment, 8 weeks during treatment

Data from ClinicalTrials.gov

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