CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 17:47:07 GMT)

CTRI Number CTRI/2019/10/021833 [Registered on: 31/10/2019] - Trial Registered Prospectively Last Modified On 25/11/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Siddha Study Design Single Arm Trial Public Title of Study STUDY ON MADHUMEGAM [TYPE 2 DIABETES MELLITUS] WITH SIDDHA MEDICINE ULOGA CHENDURAM AND OIL BATH ASHWAGANDHATHI THAILAM Scientific Title of A CLINICAL TRIAL ON THERAPEUTIC EFFICACY OF SIDDHA HERBOMINERAL Study FORMULATION ULOGA CHENDURAM (INTERNAL) AND ASHWAGANDHATHI THAILAM(OIL BATH) FOR NEERIZHIVU(NON-INSULIN DEPENDENT (TYPE II) DIABETES MELLITUS). Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr R Gomathi Trial Coordinator (multi-center study) Designation second year pg scholar Affiliation Ayodidoss pandithar hospital Address Room no:1 Department of maruthuvam, National institute of siddha, Tambaram sanatorium Chennai. Room no: 1 Department of maruthuvam, National institute of siddha, Tambaram sanatorium, chennai. Kancheepuram TAMIL NADU 600047 India Phone 9487537505 Fax 04422381314 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr T Lakshmi kantham Query) Designation Associate professor Affiliation Ayodidoss pandithar hospital Address Room no : 1 Department of maruthuvam National institute of siddha Tambaram sanatorium chennai Room no :1 Department of maruthuvam National institute of siddha Tambaram sanatorium chennai Kancheepuram TAMIL NADU 600047 India Phone 944466880 Fax 04422381314 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr R Gomathi Designation second year pg scholar Affiliation Ayodidoss pandithar hospital Address Room no: 1 Department of maruthuvam, National institute of siddha,

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Tambaram sanatorium. Room no : 1 Department of maruthuvam, National institute of siddha, Tambaram sanatorium, chennai. Kancheepuram TAMIL NADU 600047 India Phone 9487537505 Fax 04422381314 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > National institute of siddha Primary Sponsor Primary Sponsor Details Name National Institute Of Siddha Address National institute of siddha, Tambaram sanatorium, chennai Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor nil nil Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr RGomathi AYOTHIDOSS Room no :1,Department 9487537505 PANDITHAR of maruthuvam 04422381314 HOSPITAL, National ,National Institute of [email protected] Institute of Siddha, Siddha, Tambaram m sanatorium, chennai. Kancheepuram TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 20/09/2018 No ETHICS COMMITTEE Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Endocrine, nutritional and metabolic diseases Intervention / Type Name Details Comparator Agent Intervention ULOGA MANDOORAM SINGLE ARM STUDY Comparator Agent ULOGA MANDOORAM 488mg bd with thiripala decotion external ashwagandhathi thylam weekly twice for three months. Inclusion Criteria Inclusion Criteria Age From 30.00 Year(s) Age To 65.00 Year(s) Gender Both Details fasting blood sugar; above 120 mgs/dl
post prandial blood sugar; below 300mgs/dl
HbA1c 6.5%
diagonosed with or without clinical symptoms, polyuria, polydipsia, polyphagia, body pain, nocturia. weight loss, tiredness, burning feet and genital pruritis, subjects who fulfil the above three criteria wioll be included in

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the clinical trial Exclusion Criteria Exclusion Criteria Details Insulin dependent diabetes mellitus Hba1c >10% Thyroid dysfunctions gestational diabetes other endocrine abnormalities existing renal, hepatic, cardiac disease and major illness womens who are planning for pregnancy subjects who are not willing to give informed consent Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints The outcome will be mainly assessed by 90 days comparing the before and after treatment value of serum HbA1c levels Secondary Outcome Outcome Timepoints secondary outcome will be assessed by 90 days comparing the following parameters, pre and post treatment changes in siddha clinical parameters changes in investigation like fasting blood sugar, post prandial blood sugar Target Sample Size Total Sample Size=30 Sample Size from India=30 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2 Date of First 09/11/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details not yet Brief Summary This is a single arm open clinical trial , in which 30, type 2 diabetes mellitus subjects will be select based on the inclusion and exclusion criteria, after that trial drug uloga chenduram will administer to the subjects as 488mg twice a day for 90 days and ashwagandhathi thailam 50 ml for oilbath [twice a week ] for 90 days, laboratory investigation and serum Hba1c levels will be checked before and after treatment. the diet regimen will explain to the subjects, after the completion of treatment the collected data will analysed stastically and conclude.

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