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

This study has been completed.
Sponsor:
Collaborator:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Ya YUWEN, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01904695
First received: July 14, 2013
Last updated: September 4, 2016
Last verified: September 2016

July 14, 2013
September 4, 2016
August 2013
October 2015   (final data collection date for primary outcome measure)
Systolic (SBP) and diastolic (DBP) blood pressure reductions [ Time Frame: Before treatment, 8 weeks during treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01904695 on ClinicalTrials.gov Archive Site
  • Cardiac event [ Time Frame: Before treatment, 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Death incident [ Time Frame: Before treatment, 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Scores for symptoms and signs [ Time Frame: Before treatment, 8 weeks during treatment ] [ Designated as safety issue: No ]
Same as current
Possible side effects and adverse reactions [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up ] [ Designated as safety issue: Yes ]
Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded
Same as current
 
Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study
Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study
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.

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Hypertension
  • Hypertension, Resistant to Conventional Therapy
  • Drug: Herbs
    Herbs 180ml by mouth every 12 hours for 8 weeks
    Other Name: recipe of removing both phlegem and blood stasis
  • Drug: Antihypertensive drugs
    Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
    Other Name: Thiazide diuretics and ACE inhibitor and β-blocker
  • Experimental: Antihypertensive drugs & Herbs
    Thiazide diuretics and ACE inhibitor and β-blocker & Herbs for 8 weeks
    Interventions:
    • Drug: Herbs
    • Drug: Antihypertensive drugs
  • Active Comparator: Antihypertensive drugs
    Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks
    Intervention: Drug: Antihypertensive drugs
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
December 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01904695
81202846
Yes
No
Not Provided
Ya YUWEN, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Director: Ya YUWEN, PhD China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP