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

NCT ID: NCT02920125

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Aim: A non-invasive, effective, compatible, Integrative treatment option to address the growing burden of Vascular disease; Importance: Ayurvedic SUVED (cardio tonic, continuous clotlysis, endothelial repair, powerful rejuvenator, antioxidant) and Reimmugen (Cow Colostrum - IgG, GF) provides sustained Functional, symptomatic relief with clinical reports of regression of disease. No adverse interactions reported.

Application: Addition of SUVED \& REIMMUGEN helps in:

* Acute MI, Thrombotic stroke, DVT, hastens symptomatic recovery, reduces hospitalization time, mortality, helps dissolve clots / soft thrombus; reversal of atherosclerotic plaques; improves functional life
* Improvements in Cardiac Function : LVEF; Global perfusion
* Rejuvenation of endothelium, vascular function.
* Improved physical strength: digestion; GI function; immunity; accelerated internal healing
* Secondary prevention to avoid incidences in post event treatment.

Health condition/problem studied Vascular disease, esp CVA, IHD, CAD, DVT, PAD Volunteers taken from OPD and IPD of SKNMC \& GH with prior consent for participation.

Intervention is Medicament based given in addition to conventional ongoing therapy under the guidance of SKNMC doctors.

Study type Clinical trial: Double Blind placebo controlled trial. Interventional Trial: regular treatment. Evaluation of additional Integrative esp Ayurvedic medicaments on clinical and functional outcome.

Intervention and comparator agent

1. Ayurvedic ghana formulation named SUVED.
2. Whole Cow Colostrum called Reimmugen These will be given for a period of three months in addition to ongoing medication to study the additional benefit to patient in their functional and clinical investigations.

The control intervention/s is/are the interventions against which the study intervention is evaluated as double blind placebo.

Suved 1 BD for 3 months Reimmugen 1 TDS for 3 months In acute cases Suved 1 TDS Reimmugen 2 TDS for 3 months. Inclusion/ Exclusion criteria Inclusion criteria

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

Exclusion Criteria:

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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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)

Study Groups

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Trial: Ayurvedic SUVED, REIMMUGEN

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.

Group Type ACTIVE_COMPARATOR

SUVED

Intervention Type DRUG

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

REIMMUGEN

Intervention Type COMBINATION_PRODUCT

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

Control: grain flour

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

Group Type PLACEBO_COMPARATOR

Grain flour placebo

Intervention Type OTHER

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

Interventions

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SUVED

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

Intervention Type DRUG

REIMMUGEN

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

Intervention Type COMBINATION_PRODUCT

Grain flour placebo

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

Intervention Type OTHER

Other Intervention Names

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Ayurvedic Suved Reimmugen Cow Colostrum

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smt. Kashibai Navale Medical College and General Hospital

OTHER

Sponsor Role collaborator

Health Solutions, India

INDUSTRY

Sponsor Role collaborator

Sujata Vaidya

INDUSTRY

Sponsor Role lead

Responsible Party

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Sujata Vaidya

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dr Shreepad M Bhat, MD

Role: PRINCIPAL_INVESTIGATOR

Smt Kashibai Navle Medical College & Gen Hospital

Locations

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Smt Kashibai Navle Medical College and General Hospital

Pune, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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U1111-1187-7158

Identifier Type: OTHER

Identifier Source: secondary_id

SKNMC&GH-HS/001/2016

Identifier Type: -

Identifier Source: org_study_id