CTRI Number	CTRI/2012/11/003157 [Registered on: 30/11/2012] Trial Registered Prospectively
Last Modified On:	30/01/2015
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Effect of Apamarga Kshara Yoga on white patches of any part of body
Scientific Title of Study	Pharmaceutical standardization of two different dosage form of Apamarg Kshara Yoga and Their clinical efficacy on Shvitra(vitiligo)
Secondary IDs if Any Modification(s)	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Hasmukh R Jadav  Address  department of RS BK I P G T and R A Gujarat ayurved university Jamnagar 361008 Jamnagar GUJARAT 361008 India  Phone  9824085638   Fax     Email  hasmukhjadav005@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Prof P K Prajapati  Address  department of RS BK I P G T and R A Gujarat ayurved university Jamnagar 361008 Jamnagar GUJARAT 361008 India  Phone  9428315733   Fax     Email  prajapati.pradeep1@gmail.com
Details Contact Person Public Query Modification(s)	Name  DR Galib  Address  department of RS BK I P G T and R A Gujarat ayurved university Jamnagar 361008 Jamnagar GUJARAT 361008 India  Phone  9428671275   Fax     Email  galib14@yahoo.co.in
Source of Monetary or Material Support Modification(s)	Institute for Post Gradute Teaching and Research of Ayurved Gujarat Ayurved Universuty jamnagar
Primary Sponsor	Name  Institute for Post Graduate Teaching and Research in Ayurveda  Address  I P G T and R A Gujarat Ayurved Universuty Jamnagar 361008  Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Hasmukh Jadav  OPD NO 13 RS & BK IPGT & RA GAU Jamnagar  I P G T and R A Gujarat Ayurved Universuty Jamnagar 361008 Jamnagar   9824085638 hasmukhjadav005@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Patients suffering from Vitiligo
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Lepa of Apamargaksharyoga  Dose: QS for local application, once in a day at morning time Duration: 8weeks Follow up: 4weeks  Intervention  Ointment of Apamargaksharyoga  Dose: QS for local application, once in a day at morning time Duration: 8weeks Follow up: 4weeks
Inclusion Criteria	Age From  16.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  Patients having signs and symptoms of Shvitra (vitiligo). Patient between the age of 16 to 60 years. Patients with chronicity of less than 5 years.
ExclusionCriteria	Details  Patients with chronicity more than 5 years Patients having serious cardiac, renal, hepatic diseases, major illness like IDDM, NIDDM, patches due to burning, chemical exposure, any other serious systemic illness. Gravid and lactating women.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  The effect will be assessed on the basis of subjective and objective criteria. Improvement in the signs and symptoms will be appraised on the basis of special adopted scoring pattern for scrutinizing the symptomatology. The score will be given on the basis of site, size, colour, numbers, and chronicity of the patches etc.   8weeks
Secondary Outcome	Outcome  TimePoints  The effect will be assessed on the basis of subjective and objective criteria.  4weeks
Target Sample Size	Total Sample Size="30" Sample Size from India="30"
Phase of Trial Modification(s)	Phase 1
Date of First Enrollment (India)	03/12/2012
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	nil
Brief Summary Modification(s)	Brief summary for CTRI SUMMARY: The clinical study was aimed to evaluate clinical efficacy of Apamarga Kshara Yoga’s Lepa and ointment form in Shvitra (vitiligo). For inclusion of patients, specialized scoring pattern for criteria of 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 Apamarga Kshara Yoga Lepa and group B treated with Apamarga Kshara Yoga ointment for local application once in a day in the morning with exposure to sunlight for 10 minutes for 2 months. In both groups 3gm of Rasayana Churna was administered orally along with honey and ghee as adjuvant. Total 55 patients were registered in the study, out of which 50 completed the treatment. DEMOGRAPHIC DATA: Maximum numbers of patients (47.26%) were from the age group of 16-30 years, male (54.55%), unmarried (65.45%) and Hindu (92.73%) by religion. Maximum patients were having Vata Kapha Prakriti (40%), Madhyama Sara (65.46%), Madhyama Satva (56.36%), Madhyama Samhanana (72.73%). Madhyama Pramana (65.45%), Madhyama Satmya (67.27%), Madhyama Vyayama Shakti (56.36%), Mandagni (49.09%) and Madhyama Koshta (70.90%) was found in maximum patients.             In Nidanas, Ahara was dominant in Guru (88.89%) and Snigdha Guna (74.07%) and Sheeta (81.41%). Consumption of Viruddhahara (76.36%), Rasona or Plandu + Dugdha (47.27%) and Drava-Snighdha-Guru-Ahara Seavana (47.27%) was found maximum. In Vihara, Divaswapa (81.82%) and Usna Shita Kramaviruddha Sevana (47.27%) was found maximum whereas in Vegadharana (74.55%) was dominant.             Maximum patients displayed duration of disease less than one year (29.09%) and have negative family history of Shvitra (80%). Maximum patients showed symptoms of Swetabha Vaivarnyata and Mandalopatti (100%), Rukshata (49.09%), and Bahala (34.55%) of patches.             Maximum patients (80%) were found white coloured patches, and most (54.55%) were found to have more than 4 patches, maximum patients (38.18%) were found 2% involved area of the body, maximum patients (40%) were found more than 4 cm size of patches and maximum patients (52.73%) were found in moderately disease condition. RESULTS: Apamarga Kshara Yoga Lepa was seen to provide better results on colour of patches (57.26%), Number of patches (43.80%), area of patches (40.58%) and size of patches (42.42) where in Apamarga Kshara Yoga ointment shows better results on colour of patches (55.36%), Number of patches (40.20%), area of patches (35.53%) and size of patches (42.45). Both groups were observed to exhibit statistically highly significant results on colour, number, area and size of patches. No ADRs found during clinical study.             Apamarga Kshara Lepa showed moderate improvement in 52% patients, mild improvement in 32% and 16% patients showed unchanged. None of patients showed marked improvement and complete remission. In Apamarga Kshara Yoga ointment, 52% patients showed moderate improvement, 36% patients showed mild improvement and 12% patients were unchanged. None of the treated patients showed marked improvement or complete remission in both groups. Considering the satisfactory remarks by patients & observed; it can be concluded that the trial drug can be safe and used in cases of Shvitra (vitiligo). Further, trial may be attempted on the drug involving large sample size.