Traditional Chinese Medicine (TCM) constitution-based dietary intervention: a parallel-group, randomised trial
- Conditions
- Grade 1 hypertension
- Registration Number
- ITMCTR2000003496
- Lead Sponsor
- Sun Yat-Sen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) Aged >= 35 years;
2) clinically diagnosed with uncomplicated, grade 1 hypertension;
3) assessed with low risk of cardiovascular and renal events;
4) on regular follow-up by 'family doctor team' in the context of the National basic public health service delivery;
5) with no active medications on hypertension; and
6) currently not having nutritional supplements that may exert additional effects on BP levels or nutrient metabolism.
1) with symptoms of cognitive dysfunction, dementia, severe mental disorders, or other conditions with inability to appropriately convey personal thoughts;
2) secondary hypertension or resistant hypertension;
3) with a presence of hypertension-mediated organ damage (HMOD), or with severe complications of hypertension, i.e., cerebrovascular disease, coronary artery disease, heart failure, peripheral artery disease, atrial fibrillation, etc.;
4) have a family member (including relatives) who participated in the trial with a different group assignment; and
5) previously enrolled in traditional Chinese medicine (TCM) interventions requiring dietary modifications.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants who had optimal control of blood pressure at 12 months;
- Secondary Outcome Measures
Name Time Method Clinical parameters and traditional Chinese Medicine (TCM) symptoms;