A clinical trial to study the effects of Ayurvedic formulation Suved and Reimmugen (whole cow colostrum) in patients with atherosclerosis

• Register: ISRCTN
• Last refreshed on: 10 August 2020
• Main ID: ISRCTN65795273
• Date of registration: 07/11/2016
• Prospective Registration: No
• Primary sponsor: Health Solutions
• Public title: A clinical trial to study the effects of Ayurvedic formulation Suved and Reimmugen (whole cow colostrum) in patients with atherosclerosis
• Scientific title: A study to evaluate the results of integrative treatment (Ayurvedic capsules Suved and Reimmugen) for vascular disease
• Date of first enrolment: 09/10/2016
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN65795273
• Study type: Interventional
• Study design: Interventional double-blind placebo-controlled single-centre trial (Treatment)
• Phase: Phase III/IV

Countries of recruitment

India

Contacts

• Name: Sujata Vaidya

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vascular disease, atherosclerosis
Circulatory System

Intervention(s)

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).

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

NCT02920125

SKNMC - HS/SHARP/2016, CTRI/2018/02/011848

Source(s) of Monetary Support

Health Solutions (India)

Secondary Sponsor(s)

Smt. Kashibai Navale Medical College

Ethics review

Status:
Approval date:
Contact:

Ethics committee of Smt. Kashibai Navale Medical College and General Hospital, 05/10/2016, ref: SKNMC/Ethical/App/2015/115

Results

• Results available: Yes
• Date Completed: 01/09/2018