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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920125
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : September 26, 2017
Sponsor:
Collaborators:
Smt. Kashibai Navale Medical College and General Hospital
Health Solutions, India
Information provided by (Responsible Party):
Sujata Vaidya, Health Solutions, India

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Cerebro Vascular Disease Ischemic Heart Disease Deep Vein Thrombosis Peripheral Arterial Diseases Vascular Disease Drug: SUVED Combination Product: REIMMUGEN Other: Grain flour placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind, Placebo controlled, two arm, on patients of vascular disease / atherosclerosis. Intervention is given in addition to ongoing conventional therapy.
Masking: Triple (Participant, Investigator, Outcomes 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)

Primary Purpose: Treatment
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,
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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 Name: Ayurvedic Suved

Combination Product: REIMMUGEN
Whole Cow colostrum in powder put in capsules; 300mg each
Other Name: 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




Primary Outcome Measures :
  1. changes in IMT as a indicator of atherosclerosis reversal [ Time Frame: 3 months active treatment ]
    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 :
  1. Assessing the development/risk of ischaemic events in other circulations [ Time Frame: 3 months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920125


Locations
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India
Smt Kashibai Navle Medical College and General Hospital
Pune, Maharashtra, India, 411041
Sponsors and Collaborators
Sujata Vaidya
Smt. Kashibai Navale Medical College and General Hospital
Health Solutions, India
Investigators
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Principal Investigator: Dr Shreepad M Bhat, MD Smt Kashibai Navle Medical College & Gen Hospital

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Responsible Party: Sujata Vaidya, Researcher, Health Solutions, India
ClinicalTrials.gov Identifier: NCT02920125    
Other Study ID Numbers: SKNMC&GH-HS/001/2016
U1111-1187-7158 ( Other Identifier: WHO )
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: May share Data with other research agencies, Health Ministry or others.
Keywords provided by Sujata Vaidya, Health Solutions, India:
Vascular disease
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Thrombosis
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Venous Thrombosis
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Atherosclerosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases