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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1187-7158 | Other Identifier | WHO |
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| Name | Class |
|---|---|
| Smt. Kashibai Navale Medical College and General Hospital | OTHER |
| Health Solutions, India | INDUSTRY |
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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.
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:
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial: Ayurvedic SUVED, REIMMUGEN | Active Comparator | 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. |
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| Control: grain flour | Placebo Comparator | Dummy medication in same packing to mask content given in same dose as active medication. Jowari and ragi flour used in capsules |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVED | Drug | Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Shreepad M Bhat, MD | Smt Kashibai Navle Medical College & Gen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smt Kashibai Navle Medical College and General Hospital | Pune | Maharashtra | 411041 | India |
May share Data with other research agencies, Health Ministry or others.
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Double Blind, Placebo controlled, two arm, on patients of vascular disease / atherosclerosis. Intervention is given in addition to ongoing conventional therapy.
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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)
| REIMMUGEN | Combination Product | Whole Cow colostrum in powder put in capsules; 300mg each |
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| Grain flour placebo | Other | Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D020246 | Venous Thrombosis |
| D058729 | Peripheral Arterial Disease |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
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