A clinical trial to study the effects of Ayurvedic formulation Suved and Reimmugen (whole cow colostrum) in patients with atherosclerosis
Phase 3
Completed
- Conditions
- Vascular disease, atherosclerosisCirculatory System
- Registration Number
- ISRCTN65795273
- Lead Sponsor
- Health Solutions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Males or females aged 18 or over with a diagnosis of vascular disease leading to IHD, CAD, CVD, DVT or PAD at any stage
Exclusion Criteria
1. Pregnant and lactating women
2. Patients below age of 18
3. Acute IPD operative condition
4. Patients undergoing interventional procedures/surgical treatments other than for vascular disease, until they are discharged from intensive care
5. Haemorrhagic cerebrovascular stroke
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Restoration of carotid IMT to a non-pathological state, supported with positive changes in functionality and relief from associated symptoms:<br> 1. Clinical investigations will be compared pre - post treatment to evaluate percent changes in IMT and cardiac function as a mark of reversal of atherosclerosis and relief from symptoms associated with blockages in blood vessels due to atherosclerosis. IMT measurements are taken as standard to evaluate atherosclerosis and 2D echo taken for cardiac perfusion.<br> 2. Functional changes considered on the basis of symptoms of chest pain, breathlessness, stamina of walking or performing daily chores.<br> Measured at baseline and at the end of 3 months of treatment.<br>
- Secondary Outcome Measures
Name Time Method Development of ischaemic events in other circulations (e.g., in a stroke patient, evaluation of coronaries), assessed at baseline and at the end of 3 months of treatment.