Primary Hypertension, Hypertension, Resistant to Conventional Therapy
Conditions
Keywords
resistant hypertension, causal inference, a chorot study, recipe of removing both phlegm and blood stasis
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.
Interventions
DRUGHerbs
Herbs 180ml by mouth every 12 hours for 8 weeks
Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic (SBP) and diastolic (DBP) blood pressure reductions | Before treatment, 8 weeks during treatment |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac event | Before treatment, 24 weeks follow-up |
| Death incident | Before treatment, 24 weeks follow-up |
| Scores for symptoms and signs | Before treatment, 8 weeks during treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Possible side effects and adverse reactions | 2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up | Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded |
Countries
China
Outcome results
None listed