Clinical trial NCT02920125: Study the Result of Ayurvedic SUVED & Reimmugen (Colostrum) Treatment on Vascular Disease, CAD, CVA, DVT.
Official title: 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,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Cerebro Vascular Disease
Ischemic Heart Disease
Deep Vein Thrombosis
Peripheral Arterial Diseases
Vascular Disease
Keywords: Vascular disease
Lead sponsor: Health Solutions, India
Sponsor class: INDUSTRY
Collaborators: name: Smt. Kashibai Navale Medical College and General Hospital
name: Health Solutions, India
First posted: 2016-09-30
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind, Placebo controlled, two arm, on patients of vascular disease / atherosclerosis. Intervention is given in addition to ongoing conventional therapy.
Primary purpose: TREATMENT

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.

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.

Eligibility 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 intervention procedures / surgical treatments other than for Vascular disease; until they are discharged from intensive care; Hemorrhagic cerebro vascular stroke

Primary outcomes:
measure: changes in IMT as a indicator of atherosclerosis reversal
timeFrame: 3 months active treatment
Secondary outcomes:
measure: Assessing the development/risk of ischaemic events in other circulations
timeFrame: 3 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Smt Kashibai Navle Medical College and General Hospital
state: Maharashtra
Study officials:
affiliation: Smt Kashibai Navle Medical College & Gen Hospital
name: Dr Shreepad M Bhat, MD
role: PRINCIPAL_INVESTIGATOR
References: