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

A Study to Evaluate the Results of Integrative Treatment (by Including Ayurvedic Capsules Suved & Reimmugen) for Vascular Disease: Namely: Cerebro Vascular Accident - Embolic and Atherosclerotic, CVA, CAD, IHD,DVT,

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Deep Vein Thrombosis; Peripheral Arterial Diseases; Vascular Disease; Cerebro Vascular Disease
• Intervention / Treatment: Drug: SUVED; Combination product: REIMMUGEN; Other: Grain flour placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411041
      • Smt Kashibai Navle Medical College and General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: SUVED; Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each; Other Names: Ayurvedic Suved; Combination product: REIMMUGEN; Whole Cow colostrum in powder put in capsules; 300mg each; Other Names: Reimmugen Cow Colostrum
PLACEBO_COMPARATOR: 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	Other: Grain flour placebo; Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the development/risk of ischaemic events in other circulations	Secondary outcomes assessing the development/risk of ischaemic events in other circulations. Eg; in a stroke patient, evaluation of coronaries. Evaluations done within the study period of 3 months for each patient. To study the occurance of new events in other territory.	3 months

Collaborators and Investigators

• Sponsor: Sujata Vaidya
• Collaborators: Smt. Kashibai Navale Medical College and General Hospital; Health Solutions, India
• Investigators: Principal Investigator: Dr Shreepad M Bhat, MD, Smt Kashibai Navle Medical College & Gen Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (ESTIMATE): September 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Atherosclerosis; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Thrombosis; Venous Thrombosis; Cerebrovascular Disorders
• Other Study ID Numbers: SKNMC&GH-HS/001/2016; U1111-1187-7158 (OTHER: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: May share Data with other research agencies, Health Ministry or others.