Clinical trial NCT01904695: Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study
Official title: Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Primary Hypertension
Hypertension, Resistant to Conventional Therapy
Keywords: resistant hypertension
causal inference
a chorot study
recipe of removing both phlegm and blood stasis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted: 2013-07-22
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Systolic (SBP) and diastolic (DBP) blood pressure reductions
timeFrame: Before treatment, 8 weeks during treatment
Secondary outcomes:
measure: Cardiac event
timeFrame: Before treatment, 24 weeks follow-up
measure: Death incident
timeFrame: Before treatment, 24 weeks follow-up
measure: Scores for symptoms and signs
timeFrame: Before treatment, 8 weeks during treatment
Other outcomes:
measure: Possible side effects and adverse reactions
timeFrame: 2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up
Locations:
city: Beijing
country: China
facility: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Ya YUWEN, PhD
role: STUDY_DIRECTOR
References:
citation: 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.