A clinical trial to study the effects of Ayurvedic formulation Suved and Reimmugen (whole cow colostrum) in patients with atherosclerosis
| ISRCTN | ISRCTN65795273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65795273 |
| ClinicalTrials.gov number | NCT02920125 |
| Secondary identifying numbers | SKNMC - HS/SHARP/2016, CTRI/2018/02/011848 |
- Submission date
- 28/09/2016
- Registration date
- 07/11/2016
- Last edited
- 27/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atherosclerosis is a condition where the arteries become clogged with fatty substances, increasing the risk of blood clots that can block the flow of blood to the heart or brain. This can lead to life-threatening problems such as heart attacks, strokes and deep vein thrombosis (DVT). Ayurveda is a traditional system of medicine that has been practiced in the Indian subcontinent for over 3000 years. It is based on the belief that health and wellness depend on a delicate balance between the mind, body, and spirit. The aim of this study is to assess the effects of the Ayurvedic formulation Suved and Reimmugen (cow colostrum, a form of milk) in patients with artherosclerosis.
Who can participate?
Patients aged 18 or over with artherosclerosis
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group take Suved and Reimmugen. Participants in the other group take a placebo (dummy drug). Participants take these medicines by mouth as capsules for a period of 3 months in addition to their ongoing medication to study the additional benefit to them. All participants undergo tests before treatment and after 3 months of treatment which include ultrasound scans of the heart, carotid artery and lower limbs, and blood tests. Participants’ ongoing regular treatment is not changed.
What are the possible benefits and risks of participating?
Possible benefits include relief from symptoms associated with blood clots and cardiac (heart) weakness. The medicines have been used for over 7 years, no side effects have been recorded, and they can be taken with conventional medicines.
Where is the study run from?
Smt. Kashibai Navale Medical College (India)
When is the study starting and how long is it expected to run for?
September 2016 to September 2018
Who is funding the study?
Health Solutions (India)
Who is the main contact?
Dr Sujata Vaidya
drsujatavaidya@gmail.com
Contact information
Scientific
B 902
Teerth Towers
Baner Annex
Pune
411021
India
 ORCID ID |
0000-0003-4965-493X |
|---|---|
| Phone | +91 (0)982 231 1565 |
| drsujatavaidya@gmail.com |
Study information
| Study design | Interventional double-blind placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A study to evaluate the results of integrative treatment (Ayurvedic capsules Suved and Reimmugen) for vascular disease |
| Study acronym | SHARP |
| Study objectives | An equivalence trial in a pragmatic study of the clinical advantages and outcome on addition of Ayurvedic herbal formulation SUVED and cow colostrum Reimmugen to patients with vascular disease complications like ischemic heart disease (IHD), coronary artery disease (CAD), cardiovascular disease (CVD), deep vein thrombosis (DVT), and peripheral arterial disease (PAD). These advantages are clinical (intima-media thickness (IMT) studies) and functional in changes of symptoms associated with atherosclerosis/vascular blockages. |
| Ethics approval(s) | Ethics committee of Smt. Kashibai Navale Medical College and General Hospital, 05/10/2016, ref: SKNMC/Ethical/App/2015/115 |
| Health condition(s) or problem(s) studied | Vascular disease, atherosclerosis |
| Intervention | Patients are randomised to one of two groups: 1. Suved (Ayurvedic formulation, FDA India approved) and whole cow colostrum Reimmugen. Dosage decided by regular Ayurvedic use Suved 500mg one capsule twice daily: Reimmugen 300 mg one capsule three times daily in chronic subjects. Dose increased to Suved one capsule three times daily and Reimmugen two capsules three times daily in chronic acute subjects. 2. Placebo (everyday grain flour in same packaging to mask content) These will be given for a period of 3 months in addition to ongoing medication to study the additional benefit to patients in their functional and clinical investigations. Investigations done pre treatment and after 3 months treatment include the following: electrocardiogram (ECG), 2D echo cardiogram, carotid Doppler, and lower limb Doppler where necessary, angiography in few cases who opt to take the investigations, not compulsory, regular complete blood count (CBC), lipid profile, liver function test (LFT), renal function test (RFT). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Suved, Reimmugen |
| Primary outcome measure | Restoration of carotid IMT to a non-pathological state, supported with positive changes in functionality and relief from associated symptoms: 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. 2. Functional changes considered on the basis of symptoms of chest pain, breathlessness, stamina of walking or performing daily chores. Measured at baseline and at the end of 3 months of treatment. |
| Secondary outcome measures | 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. |
| Overall study start date | 24/09/2016 |
| Completion date | 01/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Single cluster. 10% variance requires 92 subjects. The aim is to study up to 200 patients to strengthen the results. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/10/2016 |
| Date of final enrolment | 01/09/2018 |
Locations
Countries of recruitment
- India
Study participating centre
Pune
411041
India
Sponsor information
Industry
B 902
Teerth Towers
Baner Annex
Pune
411021
India
| Phone | +91 (0)982 231 1565 |
|---|---|
| drsujatavaidya@gmail.com | |
| Website | www.healthsolutions.net.in |
University/education
Navle
Pune
411041
India
| Phone | +91 (0)20 2410 6390 ex 123 |
|---|---|
| smb.med@gmail.com | |
| Website | www.sknmcgh.org |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 24/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | To be published in leading medical and social journals and the media. Pilot study reporting is planned in local and international medical and social health journals. |
| IPD sharing plan |
Editorial Notes
27/07/2020: The NCT and CTRI numbers have been added.
04/07/2018: Internal review
