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

Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 22:42:55 GMT)

CTRI Number CTRI/2012/01/002362 [Registered on: 23/01/2012] - Trial Registered Prospectively Last Modified On 05/03/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Siddha Study Design Single Arm Trial Public Title of Study An open clinical trial of a Siddha formulation Kandhaga rasayanam in ringworm infection. Scientific Title of evaluation of preclinical toxicity of a siddha formulation kandhaga rasayanam and its therapeutic Study efficacy in padarthamarai(dermatophytoses) by an open clinical trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr RMeena Trial Coordinator (multi-center study) Designation Ph.D scholar (full time) Affiliation NATIONAL INSTITUTE OF SIDDHA Address no.5/10,evallappan street, sundarambal nagar, sanatorium, -47. National institute of siddha, tambaram sanatorium, chennai-47. Kancheepuram TAMIL NADU 600047 Phone 9444088634 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr RMeena Query) Designation Ph.D scholar (full time) Affiliation NATIONAL INSTITUTE OF SIDDHA Address no.5/10,evallappan street, sundarambal nagar, tambaram sanatorium, chennai-47. National institute of siddha, tambaram sanatorium, chennai-47. Kancheepuram TAMIL NADU 600047 India Phone 9444088634 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name DrRSRamaswamy Designation professor and head,department of sirappu maruthuvam, Affiliation NATIONAL INSTITUTE OF SIDDHA Address 11A/5,DURGA COLONY MAIN ROAD, ,CHENNAI. National institute of siddha, tambaram sanatorium, chennai-47. Kancheepuram TAMIL NADU 600073

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India Phone 9444941489 Fax 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 sanatoium, chennai-47 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 DrRSRamaswamy national institute of tambaram sanatorium, 944494189 siddha chennai Kancheepuram drrsramaswamy@gmail TAMIL NADU .com Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? National Institute of Approved 15/06/2011 No Siddha-institutional ethics commitee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Dermatophytosis, unspecified Patients tinea infection Intervention / Type Name Details Comparator Agent Intervention kandhaga rasayanam-2gram internal drug containing sulphur,withania somnifera,smilax china etc. Dose: 2 grams B.D Duration: 48 days. frequency of visit: 7 days once. mode of administration: oral route. Comparator Agent not applicable nO comparator used. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) Gender Both Details Patients clinically diagnosed with tinea infection (tinea pedis, cruris, corporis, capitis, barbae, mannum ,ungium.).
Patients of both sexes. Patients between 18 years to 60 years of age.
Ability to understand and sign the informed consent.
Direct microscopic examination of the skin scraping which shows positive for dermatophytes.

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Exclusion Criteria Exclusion Criteria Details Pregnant women or nursing mother. Use of other topical or oral antifungal drugs, immunosuppressive drugs, anthelmintic drugs either currently or during the 2 weeks preceding initiation of drug trial. Allergy or hypersensitivity of any component of the drug. Clinical case of Eczema, Psoriasis, Lichen planus, Pityriasis versicolor, Drug induced eruptions, Urticaria, Intertrigo. Diabetic patients.

Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints skin scrapping test negative for dermatophytes skin scrapping test negative for dermatophytes Secondary Outcome Outcome Timepoints relief from itching,burning sensation, ooze, 45 days vesicles, putules, hyperkeratosis etc Target Sample Size Total Sample Size=50 Sample Size from India=50 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 01/08/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Closed to Recruitment of Participants Trial (India) Publication Details Preclinical works published Brief Summary this is an single centric,phase 2 clinical trial. trialcentre is national institute of siddha. preclinical acute and chronic toxicity studies will be carried out as per WHO guidelines. invitro antidermatophytic activity will be done. a pilot study with 5 cases will be carried out. then main study will be conducted.the trial drug kandhaga rasayanam is chosen from classic siddha text siddha vaidhya thirattu ( approved book as per drugs and cosmetics act).

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