Study the Result of Ayurvedic SUVED & Reimmugen (Colostrum) Treatment on Vascular Disease, CAD, CVA, DVT.

NCT02920125 | Completed Phase 3 DMC

• 2 other identifiers: SKNMC&GH-HS/001/2016U1111-1187-7158
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the benefits of Ayurvedic SUVED \& REIMMUGEN Colostrum for reduction/reversal of symptoms and study clinical progress in Vascular disease; CAD, CAV, Stroke, DVT patients.

Conditions

Coronary Artery Disease; Cerebro Vascular Disease; Ischemic Heart Disease; Deep Vein Thrombosis; Peripheral Arterial Diseases; Vascular Disease

Keywords

Vascular disease

Outcome Measures

Primary Outcomes (1)

• changes in IMT as a indicator of atherosclerosis reversal

  Restoration of carotid IMT to non pathological state, supported with positive changes in functionality, relief from associated symptoms during treatment period of 3 months.

  3 months active treatment

Secondary Outcomes (1)

• Assessing the development/risk of ischaemic events in other circulations

  3 months

Study Arms (2)

Trial: Ayurvedic SUVED, REIMMUGEN

ACTIVE COMPARATOR

Ayurvedic SUVED formulation comprises of 'Ghana' extract form; Dosage :3 months, 1 BD. Content: (500mg per capsule)Terminalia Arjuna: Withania somnifera; Terminalia chebula; Cyperus rotundus; Apium graveolens; Vitis vinifera; Piper longum; Fagonia Arabica; Emblica officinalis; Terminalia belerica; Nymphaea stellata; Punica granatum; Bacopa Monnieri; and stabilizing herbs. Reimmugen Cow-colostrum is a total natural product, used as nutritional supplement Dosage: 3months, 1 TDS Contents: IgA, IgE, IgM, IgG, IgD, PRPs, Lactoferrin, Transferrin, Interferons, Cytokines, Growth Factors (bFGF, vFGF, IGF I \& II \& Angiogenesis growth Factor, Endothelial growth Factor, Nerve growth factor, PDGF), natural Vitamins and Minerals.

Drug: SUVED; Combination Product: REIMMUGEN

Control: grain flour

PLACEBO COMPARATOR

Dummy medication in same packing to mask content given in same dose as active medication. Jowari and ragi flour used in capsules

Other: Grain flour placebo

Interventions

SUVED DRUG

Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each

Also known as: Ayurvedic Suved

Trial: Ayurvedic SUVED, REIMMUGEN

REIMMUGEN COMBINATION_PRODUCT

Whole Cow colostrum in powder put in capsules; 300mg each

Also known as: Reimmugen Cow Colostrum

Trial: Ayurvedic SUVED, REIMMUGEN

Grain flour placebo OTHER

Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos

Control: grain flour

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females with a diagnosis of Vascular disease leading to IHD, CAD, CVA, DVT, PAD at any stage

You may not qualify if:

• Pregnant and lactating women
• Patients below age of 18
• Acute IPD operative condition
• Patients undergoing intervention procedures / surgical treatments other than for Vascular disease; until they are discharged from intensive care; Hemorrhagic cerebro vascular stroke

Sponsors & Collaborators

• Sujata Vaidya: lead
• Smt. Kashibai Navale Medical College and General Hospital: collaborator
• Health Solutions, India: collaborator

Study Sites (1)

Smt Kashibai Navle Medical College and General Hospital

Pune, Maharashtra, 411041, India

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Venous Thrombosis; Peripheral Arterial Disease; Vascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Thrombosis; Embolism and Thrombosis; Atherosclerosis; Peripheral Vascular Diseases

Study Officials

• Dr Shreepad M Bhat, MD

  Smt Kashibai Navle Medical College & Gen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For subjects/patients -Control and Trial medication are packaged in same looking blister / alu alu strips. For Investigator and Outcome Assessor: no information on patient allocation (trial or Control group)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Double Blind, Placebo controlled, two arm, on patients of vascular disease / atherosclerosis. Intervention is given in addition to ongoing conventional therapy.

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 30, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

IN (1)