Condition category
Circulatory System
Date applied
28/09/2016
Date assigned
07/11/2016
Last edited
07/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Protocol/serial number

SKNMC - HS/SHARP/2016

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 measures

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

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

www.healthsolutions.net.in

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

www.sknmcgh.org

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes