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

Completed

Phase 3 Results N/A

Trial Description

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

Interventions

  • Ayurvedic Suved and Whole cow colostrum Drug
    Other Names: Suved; Reimmugen
    Intervention Desc: placebo dummy medicaments in same looking packaging
    ARM 1: Kind: Experimental
    Label: Integrative ayurvedic
    Description: Medications given in addition to conventional therapy to evaluate additional benefits. Ayurvedic Suved and whole cow colostrum Reimmugen are given as additional therapy to conventional medication.
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Dummy medication in same packing to mask content given in same dose as active medication.
  • SUVED Drug
    Other Names: Ayurvedic Suved
    Intervention Desc: Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each
    ARM 1: Kind: Experimental
    Label: Trial: Ayurvedic SUVED, REIMMUGEN
    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.
  • REIMMUGEN Combination Product
    Other Names: Reimmugen Cow Colostrum
    Intervention Desc: Whole Cow colostrum in powder put in capsules; 300mg each
    ARM 1: Kind: Experimental
    Label: Trial: Ayurvedic SUVED, REIMMUGEN
    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.
  • Grain flour placebo Other
    Intervention Desc: Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos
    ARM 1: Kind: Experimental
    Label: Control: grain flour
    Description: Dummy medication in same packing to mask content given in same dose as active medication. Jowari and ragi flour used in capsules

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Pharmacokinetics/Dynamics Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary changes in IMT as a indicator of atherosclerosis reversal 3 months active treatment No
Secondary Assessing the development/risk of ischaemic events in other circulations 3 months No

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