Smt Kashibai Navle Medical College and General Hospital
Pune, Maharashtra, 411041, India
NCT Number: NCT02920125
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Pune, Maharashtra, 411041, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each
Other names: Ayurvedic Suved
Whole Cow colostrum in powder put in capsules; 300mg each
Other names: Reimmugen Cow Colostrum
Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos
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.
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.
Sujata Vaidya
Industry
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,
Acronym: SHARP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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