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

Primary Purpose

Coronary Artery Disease, Cerebro Vascular Disease, Ischemic Heart Disease

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
SUVED
REIMMUGEN
Grain flour placebo
Sponsored by
Sujata Vaidya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Vascular disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Smt Kashibai Navle Medical College and General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Trial: Ayurvedic SUVED, REIMMUGEN

Control: grain flour

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2016
Last Updated
September 25, 2017
Sponsor
Sujata Vaidya
Collaborators
Smt. Kashibai Navale Medical College and General Hospital, Health Solutions, India
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1. Study Identification

Unique Protocol Identification Number
NCT02920125
Brief Title
Study the Result of Ayurvedic SUVED & Reimmugen (Colostrum) Treatment on Vascular Disease, CAD, CVA, DVT.
Acronym
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,
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sujata Vaidya
Collaborators
Smt. Kashibai Navale Medical College and General Hospital, Health Solutions, India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Ayurvedic ghana formulation named SUVED. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cerebro Vascular Disease, Ischemic Heart Disease, Deep Vein Thrombosis, Peripheral Arterial Diseases, Vascular Disease
Keywords
Vascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double Blind, Placebo controlled, two arm, on patients of vascular disease / atherosclerosis. Intervention is given in addition to ongoing conventional therapy.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial: Ayurvedic SUVED, REIMMUGEN
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control: grain flour
Arm Type
Placebo Comparator
Arm Description
Dummy medication in same packing to mask content given in same dose as active medication. Jowari and ragi flour used in capsules
Intervention Type
Drug
Intervention Name(s)
SUVED
Other Intervention Name(s)
Ayurvedic Suved
Intervention Description
Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each
Intervention Type
Combination Product
Intervention Name(s)
REIMMUGEN
Other Intervention Name(s)
Reimmugen Cow Colostrum
Intervention Description
Whole Cow colostrum in powder put in capsules; 300mg each
Intervention Type
Other
Intervention Name(s)
Grain flour placebo
Intervention Description
Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos
Primary Outcome Measure Information:
Title
changes in IMT as a indicator of atherosclerosis reversal
Description
Restoration of carotid IMT to non pathological state, supported with positive changes in functionality, relief from associated symptoms during treatment period of 3 months.
Time Frame
3 months active treatment
Secondary Outcome Measure Information:
Title
Assessing the development/risk of ischaemic events in other circulations
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Shreepad M Bhat, MD
Organizational Affiliation
Smt Kashibai Navle Medical College & Gen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smt Kashibai Navle Medical College and General Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411041
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
May share Data with other research agencies, Health Ministry or others.

Learn more about this trial

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

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