Coronary Artery DiseasePhase 3SHARPNCT02920125
Study the Result of Ayurvedic SUVED & Reimmugen (Colostrum) Treatment on Vascular Disease, CAD, CVA, DVT.
A Phase 3 study testing SUVED and REIMMUGEN in people with Coronary Artery Disease and Cerebro Vascular Disease, run by Sujata Vaidya at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Cerebro Vascular Disease, Ischemic Heart Disease
- What is being tested?
- SUVED and REIMMUGEN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2016to Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females with a diagnosis of Vascular disease leading to IHD, CAD, CVA, DVT, PAD at any stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Smt Kashibai Navle Medical College and General Hospital
Pune, Maharashtra, 411041
About this study
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,
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Cerebro Vascular Disease, Ischemic Heart Disease, Deep Vein Thrombosis, Peripheral Arterial Diseases, Vascular Disease
- Being tested
- SUVED, REIMMUGEN, Grain flour placebo
- Keywords
- Vascular disease
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Venous Thrombosis, Peripheral Arterial Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVEDDrug
Also called Ayurvedic Suved
Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each
REIMMUGENCombination product
Also called Reimmugen Cow Colostrum
Whole Cow colostrum in powder put in capsules; 300mg each
Grain flour placeboOther
Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SUVED; Combination Product: REIMMUGEN |
| 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 Receives: Other: Grain flour placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months active treatment
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sujata Vaidya
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smt. Kashibai Navale Medical College and General Hospital, Health Solutions, India
- Responsible party
- Sponsor-investigator, Sujata Vaidya, Health Solutions, India
- Investigators
- Dr Shreepad M Bhat, MD, Principal investigator, Smt Kashibai Navle Medical College & Gen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920125
- Sponsor's protocol ID
- SKNMC&GH-HS/001/2016
- Other IDs
- U1111-1187-7158
- Acronym
- SHARP
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2016
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: May share Data with other research agencies, Health Ministry or others.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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,
- ClinicalTrials.gov ID
- NCT02920125
- Acronym / sponsor ID
- SHARP / SKNMC&GH-HS/001/2016
- Conditions
- Coronary Artery Disease, Cerebro Vascular Disease, Ischemic Heart Disease, Deep Vein Thrombosis, Peripheral Arterial Diseases, Vascular Disease
- Keywords
- Vascular disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sujata VaidyaIndustry (pharma, biotech, devices)
- Collaborators
- Smt. Kashibai Navale Medical College and General Hospital, Health Solutions, India
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind, Placebo controlled, two arm, on patients of vascular disease / atherosclerosis. Intervention is given in addition to ongoing conventional therapy.
| Arm | Type | Receives |
|---|---|---|
| Trial: Ayurvedic SUVED, REIMMUGEN | Active comparator | Drug: SUVED, Combination Product: REIMMUGENAyurvedic 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. |
| Control: grain flour | Placebo comparator | Other: Grain flour placeboDummy medication in same packing to mask content given in same dose as active medication. Jowari and ragi flour used in capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult males or females with a diagnosis of Vascular disease leading to IHD, CAD, CVA, DVT, PAD at any stage
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUVEDAlso: Ayurvedic SuvedAyurvedic formulation in ghana (concentrated) in capsules; 500 mg each | Drug | Trial: Ayurvedic SUVED, REIMMUGEN |
| REIMMUGENAlso: Reimmugen Cow ColostrumWhole Cow colostrum in powder put in capsules; 300mg each | Combination product | Trial: Ayurvedic SUVED, REIMMUGEN |
| Grain flour placeboGrain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos | Other | Control: grain flour |
Primary outcome
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.
1 secondary outcome
Assessing the development/risk of ischaemic events in other circulations
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: Undecided. May share Data with other research agencies, Health Ministry or others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shreepad M Bhat, MD principal investigator
Smt Kashibai Navle Medical College & Gen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SUVED and REIMMUGEN in people with Coronary Artery Disease and Cerebro Vascular Disease, run by Sujata Vaidya at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in IMT as a indicator of atherosclerosis reversal (time frame: 3 months active treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.