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1 Clinical Trial Details (PDF Generation Date :- Fri, 15 Mar :54:24 GMT) CTRI Number Last Modified On 29/10/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/12/ [Registered on: 23/12/2013] - Trial Registered Retrospectively Yes Interventional Drug Ayurveda Randomized, Parallel Group Trial Effect of Savarnakara yoga on Shvitra (a condition associated with depigmentation) Pharmaceutical standardization of two different dosage forms of Savarnakara yoga and its efficacy on Shvitra (Vitiligo) 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) Details of Principal Investigator RAHUL SHINGADIYA MD SCHOLAR IPGT AND RA Phone Fax Room no 106 Boys hostel Institute for Post Graduate Teaching and Research in Ayurveda GAU Gujarat shingadiyarahul@yahoo.in Details Contact Person (Scientific Query) prof PK Prajapati Prof. and Head Phone Fax Institute for Post Graduate Teaching and Research in Ayurveda GAU Department of RS and BK Institute for Post Graduate Training and Research in Ayurved GAU prajapati.pradeep1@gmail.com Details Contact Person (Public Query) prof PK Prajapati Prof. and Head Institute for Post Graduate Teaching and Research in Ayurveda GAU Department of RS and BK Institute for Post Graduate Training and Research in Ayurved GAU page 1 / 5

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 Inclusion Criteria Phone Fax prajapati.pradeep1@gmail.com Source of Monetary or Material Support > Institute for Post Graduate Teaching and Research in Ayurveda jamnagar Type of Sponsor List of Countries of Principal Investigator RAHUL SHINGADIYA Primary Sponsor Details Institute for Post Graduate Teaching and Research in Ayurveda Institute for Post Graduate Teaching and Research in Ayurveda jamnagar Research institution and hospital of Site Site Phone/Fax/ Institute for Post Graduate Training and Research in Ayurved Department of RS and BK Institute for Post Graduate Training and Research in Ayurved GAU shingadiyarahul@yaho o.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional ethics committee Institute for Post Graduate Training and Research in Ayurved GAU Status Not Applicable Health Type Patients Approved 10/09/2013 No Date No Date Specified Condition patients having signs and symptoms of shvitra(vitiligo) Type Details Intervention group A Savarnakara lepa lepa for local application qs Internally kanakbindwarishta-10 ml BD with water. Duration 2 month Comparator Agent group B Savarnakara ointment onitment for local application qs Internally kanakbindwarishta-10 ml BD with water duration 2 month Age From Age To Year(s) Year(s) Inclusion Criteria page 2 / 5

3 Exclusion Criteria Gender Details Details Both Patients having sign and symptoms of Shvitra (vitiligo). Patients with Chronicity less than 10 years. Exclusion Criteria Patients having Chronic condition : more than 10 years All other de-pigmentory disorders. Patients having serious cardiac, renal, hepatic diseases. Patients having major illness like Diabetes mellitus which is poorly controlled. Patches due to burning, chemical explosion etc. Located at region of Guhya, Panitala, Oshtha, Aekanga, Sarvanga. Patches with Raktaroma & sansakta. Any other serious systemic illness. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization An Open list of random numbers Open Label Primary Outcome Outcome Timepoints Improvement will be assessed on the basis of relief found in cardinal symptoms of disease. Progress in the signs and symptoms based on the standard pattern will be applied before and after treatment. 28 days Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Improvement will be assessed on the basis of relief found in cardinal symptoms of disease. Progress in the signs and symptoms based on the standard pattern will be applied before and after treatment. Total Sample Size=30 Sample Size from =30 21/12/2013 No Date Specified Years=1 Months=2 Days=0 Not Applicable Open to Recruitment 28 days Standard manufacturing procedure and quality parameters of Kanakbindvarishta Rahul Shingadiya, Kinnari Dhruve, VJ Shukla, Prajapati PK International Journal of Herbal Medicine 2015; 3(1): SUMMARY: The clinical study was aimed to evaluate clinical efficacy of Savarnakara Yoga s Lepa and ointment form in Shvitra (vitiligo). For inclusion of patients, specialized scoring pattern for criteria of page 3 / 5

4 assessment was adopted. Thereafter the observations and results are presented in tabular form followed by interpretation. The overall assessment of therapy was deduced on the basis of scoring pattern. POSOLOGY & GROUPING: Selected patients were randomly divided (by following computer generated randomisation sequence) into two groups viz; group A treated with Savarnakara Lepa and group B treated with Savarnakara ointment for local application once in a day in the morning with exposure to sunlight for minutes for 2 months. In both groups 10 ml of Kanakabindvarishta was administered orally with equal quantity of water twice a day after meal. Total 60 patients were registered in the study, out of which 52 completed the treatment. DEMOGRAPHIC DATA: Maximum numbers of patients (40%) were from the age group of years, were male (53.33%), married (70%) and Hindu (98.33%) by religion. Maximum patients were having Vata pitta Prakriti (65%), Twaka Sara (41.67%), Madhyama Satva (58.33%), Madhyama Samhanana (65%). Madhyama Pramana (63.33%), Madhyama Satmya (63.33%), Madhyama Vyayama Shakti (50%), Mandagni (48.33%) and Krura Koshta (43.33%) was found in maximum patients. In Nidanas, Ahara dominant in Madhura (73.33%), Guru (50%) and Ushna Guna (60%) was dominant. Also consumption of Viruddhahara (76.36%), Lavana + Dugdha (30%) and Mithya ahara (70%) food pattern (55%), Psychological disturbance during meal (40%) were found maximum. In Vihara, Vegavidharana (43.33%) and Divaswapa (40%) were found maximum. Maximum patients displayed duration of disease of ten year (20%) and negative family history of Shvitra (68.33%) and positive medication history (78.33%). Maximum patients showed symptoms of Swetabha Vaivarnyata (56.67%) and Mandalopatti (90%), Snigdhata (38.33%), and Kandu(38.33%) of patches. Maximum patients (56.37%) were found white coloured patches, maximum patients (53.33%) were found more than 4 patches, maximum patients (46.67%) were found 5 to 25% involved area of the body, maximum patients (23.33%) were found 2 cm size of patches and maximum patients (65%) were found in severe disease condition. page 4 / 5

5 Powered by TCPDF ( RESULTS: Savarnakara Lepa was seen to provide better results on size of patches (52.77%), Number of patches (27.46%), Saparidaha (399%) and Kandu (145%) where in Savarnakara ointment shows better result on area of patches (22.67%), colour of patches (61.42%) and Rukshata (100%). On statistical analysis, both groups were also seen to exhibit statistically highly significant results on colour, Number, area and size of patches, saparidaha and a kandu and significant on rukshata. Savarnakara Lepa showed moderate improvement in 20.83% patients, mild improvement in 75% and 4.17% patients showed unchanged as well as worsened. None of patient showed marked improvement and complete remission or remarked. In Savarnakara ointment, 7.14% patient showed marked improvement, 17.86% patients showed moderate improvement, 60.71% patients showed mild improvement, and 14.29% patients showed unchanged as well as worsened. None of patient showed marked improvement and complete remission or remarked. Blisters were observed in few patients but it cannot be considered as untoward effects due to presence of psoralen in Bakuchi, which is positive sign in the management of Shvitra. Considering the satisfactory remarks by patients & observed; it can be concluded that both the forms of Savarnakara Yoga are found as a safe remedy in vitiligo with significant pigment regenerating capacity as topical use. Further, trial may be attempted on the drug involving large sample size. page 5 / 5