PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Fri, 09 Nov :32:51 GMT) CTRI Number Last Modified On 23/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/08/ [Registered on: 23/08/2013] - Trial Registered Retrospectively Yes Interventional Drug Ayurveda Randomized, Parallel Group, Active Controlled Trial Hypothyroidism and its management with Ayurveda A Clinical Study On the Role of Vamana and Virechana in the management of Hypothyroidism with Punarnava Amruta Guggulu Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Designation Affiliation Details of Principal Investigator PRATIKSHA PATERIYA Phone Fax Designation Affiliation PG Scholar Department of Panchkarma Gujarat Ayurveda University JAMNAGAR GUJRAT Gujarat Ayurveda University JAMNAGAR drpratikshaayu@gmail.com Details Contact Person (Scientific Query) Prof M S Baghel Phone Fax Designation Affiliation Director of Institute for Post Graduate Teaching and Research Ayurveda Gujarat Gujrat Ayurveda University JAMNAGAR Gujrat Ayurveda University JAMNAGAR baghelayu@rediffmail.com Details Contact Person (Public Query) Dr Anup B Thakar Associate Professor and HOD of Panchkarma Department Gujarat page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone Fax > Gujarat Ayurveda University Type of Sponsor List of Countries of Principal Investigator Dr pratiksha pateriya Gujrat Ayurveda University JAMNAGAR Gujrat Ayurveda University JAMNAGAR anup_thakar@yahoo.com Source of Monetary or Material Support Primary Sponsor Details Institute for Post GraduateTeaching and Reseach in Ayurveda Gujarat Ayurveda University Gujarat Ayurveda University Research institution and hospital of Site Site Phone/Fax/ Institute for Post Graduate Teaching and Research in Ayurveda Department of Panchkarma OPD No 20 Gujarat drpratikshaayu@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Approved 21/09/2012 No Status Not Applicable Health Type Patients Date No Date Specified Condition HYPOTHYROIDISM Type Details Intervention Group B Virechana karma followed by punaranava amruta guggulu Virechana karma with Trikatu churna 2gram Triphala churna 5gram Danti churna 10gram Trivritta churna 10gram Chitraka churna 1gram Snuhi kshira 10ml Gudodaka 80ml for 1 day followed by punaranava amruta page 2 / 7

3 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Intervention Comparator Agent Age From Age To Gender Details Details Group A Vamana karma followed by punaranava amruta guggulu Group C Controlled drug Levothyroxine sodium Year(s) Year(s) Both Coin toss, Lottery, toss of dice, shuffling cards etc An Open list of random numbers Open Label Inclusion Criteria guggulu 500mg 2 tablets thrice in a day for 45 days Vamana karma with madanphalapippali churna 10gram vacha churna 5gram saidhava 10gram Madhu 50ml for 1 day followed by punaranava amruta guggulu 500mg 2 tablets thrice in a day for 45 days Dose as recommended by modern physician empty stomach in morning with water for 45 days Patients with clinical features of Hypothyroidism namely increase level of serum TSH decrease level of serum T3 serum T4 irregular menstruation weakness fatigue weight gain hair fall constipation puffiness of face bilateral peripheral edema dry and coarse skin palpitation cold intolerance lethargy Exclusion Criteria Patients with Ischemic heart diseases Uncontrolled hypertension Myocardial infarction Cardiovascular event Cardiac arrhythmia Pregnancy Active malignant disease Primary Outcome Outcome Timepoints The efficacy of treatment will be assessed on the basis of relief in signs and symptoms Evaluation of BIOCHEMICAL parameters such as serum TSH serum T3 and T4 in all groups with Hematological Urine routine and microscopic examination before and after treatment 60 Days in two interventional group A B and 45 Days in Controle group Secondary Outcome Outcome Timepoints Target Sample Size Exacerbation in signs and symptoms Total Sample Size=45 Sample Size from =45 Phase of Trial Phase 1/ Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) 05/02/2013 No Date Specified Years=1 Months=2 Days=0 Not Applicable 4 Weeks page 3 / 7

4 Recruitment Status of Trial () Publication Details Brief Summary Open to Recruitment The present study is designed with the aims to study to evaluate the efficacy of Vamana karma in the management of Hypothyroidism, to study to evaluate the efficacy of Virechana karma in the management of Hypothyroidism after this as shamana drug PUNARANAVA AMRUTA GUGGULU in both groups and group C is controle with tablet Levothyroxine sodium IN GROUP A VAMANA KARMA Deepan pachana Trikatu churna 2g TDS with luke warm water 3-7days Snehpan Go ghrita as per Koshtha 3-7days Abhyanga and Swedana Bala oil 2 times a day 1day vamana yoga(1day) Madanphalapippali 6-10g Vacha churna 2-5g Saidhava 5-10g Honey 50ml Yastimadhu phant 2-3 Liter samsarjana karma Diet (as per shuddhi) 3-7days page 4 / 7

5 IN GROUP B VIRECHANA KARMA Deepan pachana(as Snehpana(as above) Abhyanga Swedana 3days Bala oil Virechana yoga(1 day) Trikatu churna 2g Triphala churna 5g Danti churna 10g Trivritta churna 10g Chitraka churna 1g 10ml Snuhikshira 40-80ml Gudodaka Samsarjana karma (as per shuddhi) page 5 / 7

6 3-7 days Internal Shamana yoga :Punaranava amruta guggulu 1g tds(2 tablets each 500mg) ANUPAN:Luke warm water 45 days GROUP C : Standered controle Tab Levothyroxine sodium dose :as per physician prescribe 45 days CRITERIYA FOR ASSESSMENT: The efficacy of treatment will be assessed on the basis of relief in signs and symptoms On the basis of changes in the laboratory investigation Status of Dosha,Dushya and Agni will be assessed before after treatment FOLLOW UP: Follow up will be done for four weeks after the complition of treatment to see the long standing effect of the treatment. page 6 / 7

7 Powered by TCPDF ( PDF of Trial Patients will be redirected to regular OPD treatment after the stipulated time of research work. page 7 / 7