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

Primary Purpose

Primary Hypertension, Hypertension, Resistant to Conventional Therapy

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Herbs
Antihypertensive drugs
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypertension focused on measuring resistant hypertension, causal inference, a chorot study, recipe of removing both phlegm and blood stasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antihypertensive drugs & Herbs

Antihypertensive drugs

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiac event
Death incident
Scores for symptoms and signs

Full Information

First Posted
July 14, 2013
Last Updated
September 4, 2016
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01904695
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension, Hypertension, Resistant to Conventional Therapy
Keywords
resistant hypertension, causal inference, a chorot study, recipe of removing both phlegm and blood stasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antihypertensive drugs & Herbs
Arm Type
Experimental
Arm Description
Thiazide diuretics and ACE inhibitor and β-blocker & Herbs for 8 weeks
Arm Title
Antihypertensive drugs
Arm Type
Active Comparator
Arm Description
Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Herbs
Other Intervention Name(s)
recipe of removing both phlegem and blood stasis
Intervention Description
Herbs 180ml by mouth every 12 hours for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Antihypertensive drugs
Other Intervention Name(s)
Thiazide diuretics and ACE inhibitor and β-blocker
Intervention Description
Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
Primary Outcome Measure Information:
Title
Systolic (SBP) and diastolic (DBP) blood pressure reductions
Time Frame
Before treatment, 8 weeks during treatment
Secondary Outcome Measure Information:
Title
Cardiac event
Time Frame
Before treatment, 24 weeks follow-up
Title
Death incident
Time Frame
Before treatment, 24 weeks follow-up
Title
Scores for symptoms and signs
Time Frame
Before treatment, 8 weeks during treatment
Other Pre-specified Outcome Measures:
Title
Possible side effects and adverse reactions
Description
Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded
Time Frame
2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya YUWEN, PhD
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25797643
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.
Results Reference
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Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study

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