Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sujata Vaidya
ORCID ID
http://orcid.org/0000-0003-4965-493X
Contact details
B 902
Teerth Towers
Baner Annex
Pune
411021
India
+91 (0)982 231 1565
drsujatavaidya@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02920125
Protocol/serial number
SKNMC - HS/SHARP/2016, CTRI/2018/02/011848
Study information
Scientific title
A study to evaluate the results of integrative treatment (Ayurvedic capsules Suved and Reimmugen) for vascular disease
Acronym
SHARP
Study hypothesis
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
Ethics committee of Smt. Kashibai Navale Medical College and General Hospital, 05/10/2016, ref: SKNMC/Ethical/App/2015/115
Study design
Interventional double-blind placebo-controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Phase III/IV
Drug names
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 trial start date
24/09/2016
Overall trial end date
01/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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.
Participant 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
Recruitment start date
09/10/2016
Recruitment end date
01/09/2018
Locations
Countries of recruitment
India
Trial participating centre
Smt. Kashibai Navale Medical College
Navle
Pune
411041
India
Sponsor information
Organisation
Health Solutions
Sponsor details
B 902
Teerth Towers
Baner Annex
Pune
411021
India
+91 (0)982 231 1565
drsujatavaidya@gmail.com
Sponsor type
Industry
Website
Organisation
Smt. Kashibai Navale Medical College
Sponsor details
Navle
Pune
411041
India
+91 (0)20 2410 6390 ex 123
smb.med@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Health Solutions (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
24/09/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list