CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 08:36:33 GMT)

CTRI Number CTRI/2016/12/007523 [Registered on: 02/12/2016] - Trial Registered Retrospectively Last Modified On 16/11/2016 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Ayurveda Study Design Single Arm Trial Public Title of Study Single Blind Clinical Study of Shodhana Karma and an indigenous Drug Combination on Polycystic Ovarian Disease Scientific Title of Single Blind Clinical Study of Shodhana Karma and an indigenous Drug Combination on Polycystic Study Ovarian Disease Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Mamatha Trial Coordinator (multi-center study) Designation Professor Affiliation SDM College of Ayurveda and Hospital Kuthpady Address Department of Prasuti Tantra and Streeroga SDM College of Ayurveda and Hospital, Kuthpady Udupi District 574118 Karnataka Department of Prasuti Tantra and Streeroga Udupi KARNATAKA 574118 India Phone 08202520332 Fax 08202533970 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Mamatha Query) Designation Professor Affiliation SDM College of Ayurveda and Hospital Kuthpady Address Department of Prasuti Tantra and Streeroga SDM College of Ayurveda and Hospital, Kuthpady Udupi District 574118 Karnataka Department of Prasuti Tantra and Streeroga Udupi KARNATAKA 574118 India Phone 08202520332 Fax 08202533970 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Mamatha Designation Professor Affiliation SDM College of Ayurveda and Hospital Kuthpady Address Department of Prasuti Tantra and Streeroga SDM College of Ayurveda and Hospital, Kuthpady Udupi District 574118 Karnataka Department of Prasuti Tantra and Streeroga Udupi

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KARNATAKA 574118 India Phone 08202520332 Fax 08202533970 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ayurveda formulations Primary Sponsor Primary Sponsor Details Name Rajiv Gandhi University of Health Sciences Karnataka Address 4th T Block Jayanagar Bangalore 560 041 Type of Sponsor Government funding agency Details of Secondary Name Address Sponsor Department of AYUSH Ministry of Health and Family Welfare, New Delhi 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 Mamatha KV SDM College of Room no. 103, 9448215605 Ayurveda and Hospital Department of Prasuti 08202533970 Kuthpady Udupi Tantra and Stree Roga, [email protected] SDM Ayurveda Hospital Kuthpady Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IEC-Human Approved 03/12/2015 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Diagnostic cases of PCOD Intervention / Type Name Details Comparator Agent Comparator Agent No No comparator agent used in the study Intervention Asanadi gana quata, Asanadi gana quata 50 ml twice Kanchanaraguggulu and a day orally for 6 months and shatapushpa churna Kanchanara guggulu 2 tablet twice a day orally for 6 months and Shatapushpa churna 5 gm twice a day orally for 6 months Inclusion Criteria Inclusion Criteria Age From 15.00 Year(s) Age To 45.00 Year(s) Gender Female Details PCOD with hypothyroidism
PCOD with infertility
PCOD with menstrual irregularity
Diagnostic cases of PCOD with the help of ultrasonography and hormonal assay

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Exclusion Criteria Exclusion Criteria Details Cases of obesity other than PCOD Ammenorrhoea due to pregnancy, genital tuberculosis and premature ovarian failure PCOD cases with severe systemic illness

Method of Generating Not Applicable Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Regularization of menstrual cycle Regularization of menstrual cycle Conception in eligible infertile couple Conception in eligible infertile couple Normalization of PCOD findings in Normalization of PCOD findings in ultrasonography and hormonal assay ultrasonography and hormonal assay

Secondary Outcome Outcome Timepoints Regularization of menstrual cycle 6 months Conception in eligible infertile couple Normalization of PCOD findings in ultrasonography and hormonal assay

Target Sample Size Total Sample Size=100 Sample Size from India=100 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 3 Date of First 01/04/2016 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 Open to Recruitment Trial (India) Publication Details Will be published in Peer reviewed index journal Brief Summary PCOD is a widely seen life style disorder affecting the adolescent and reproductive age group of patients which needs an urgent, sure, safe, permanent yet a cost effective solution. In treasures of Ayurveda lot of such combinations are available which are safe, cost effective, non-invasive and time tested. But lack of documented scientific data regarding this is limiting its wide acceptance worldwide and in the scientific community. Polycystic ovarian disease which is very much benign to start with presenting as menstrual disturbance, obesity and hirsutism but if neglected may progresses into a full blown syndromic presentation having infertility, hypertension, hyperlipidemia, atherosclerosis, endometrial carcinoma etc. Tragedy is, the adolescents of the nation who has to concentrate on

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their studies and constructive work are spending time in the labs and clinics for diagnosing and getting treatment for this frustrating condition. In the current study diagnosed patients of PCOD from the OPD of SDM Hospital of Ayurveda are randomly selected after screening them for the prefixed inclusion and exclusion criteria. As the disease is not self limiting the control group is not considered. The selected patients are thoroughly assessed before treatment with the help of the detailed proforma and investigated. Based on their presentation and body constitution a course of udgharshana and rookshana followed by vamana or virechana are administered as shodhana therapy. Asanadi gana quata and kanchanaraguggulu having the property of kapha meda haratwa, being indicated in granti and prameha, shatapushpa churna acting as vyadhi pratyaneeka chikitsa in the said disorder and hence they are administered in all kinds of presentations of the patients. The oral medication is continued for a period of six months as the results can’t be expected with short treatment period in this case. At the end of 6 months investigations are repeated and patients are reevaluated for changes. In case of conception, total reversal of the condition or on observing any adverse effects of the treatment the medication is interrupted and patient is managed as per the need. The completed patients are evaluated with the proper assessment criteria and the results are analyzed with the appropriate statistical methods and the results will be documented.

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