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

Coronary Artery Disease Clinical Trial

— SHARP  

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,

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920125
• Other study ID #: SKNMC&GH-HS/001/2016
• Secondary ID: U1111-1187-7158
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2016
• Last updated: September 25, 2017
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Health Solutions, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebro Vascular Disease
• Cerebrovascular Disorders
• Coronary Artery Disease
• Coronary Disease
• Deep Vein Thrombosis
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases
• Thrombosis
• Vascular Disease
• Vascular Diseases
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
India	Smt Kashibai Navle Medical College and General Hospital	Pune	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
Sujata Vaidya	Health Solutions, India, Smt. Kashibai Navale Medical College and General Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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