Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-17 @ 6:43 PM
Study NCT ID:
NCT01904695
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2013-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: