NCT02920125

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

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,

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Sujata Vaidya · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	SUVED	Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each
COMBINATION_PRODUCT	REIMMUGEN	Whole Cow colostrum in powder put in capsules; 300mg each
OTHER	Grain flour placebo	Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-08-01
• Completion: 2017-09-01
• First posted: 2016-09-30
• Last updated: 2017-09-26

Locations

1 site across 1 country: India