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CTRI Number  CTRI/2015/07/005986 [Registered on: 08/07/2015] Trial Registered Prospectively
Last Modified On: 19/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of white patches (leucoderma) by herbo-mineral gel 
Scientific Title of Study   Pharmaceutico-therapeutic evaluation of gel prepared from Karpanpatru Taila and Shvitrahara Yoga on Shvitra (vitiligo) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hasmukh R Jadav 
Designation  PhD Scholar 
Affiliation  Institute for post graduate teachind and research in Ayurveda 
Address  Room no 29 PG Boys Hostel IPGT and RA GAU Jamnagar
Room no 29 PG Boys Hostel IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone    
Fax    
Email  hasmukhjadav005@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Galib 
Designation  Assistant professor 
Affiliation  Institute for post graduate teachind and research in Ayurveda 
Address  Dept of RS and BK IPGT and RA GAU Jamnagar
Dept of RS and BK IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone    
Fax    
Email  galib14@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof P K Prajapati 
Designation  Director and Head of Department 
Affiliation  Institute for post graduate teachind and research in Ayurveda 
Address  Head Dept of RS and BK IPGT and RA GAU Jamnagar
Head Dept of RS and BK IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone    
Fax    
Email  Prajapati.prdeep1@gmail.com  
 
Source of Monetary or Material Support  
PG Hospital Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Opposite relience fresh Jamnagar - 361008 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Opposite relience fresh Jamnagar - 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Hasmukh R Jadav  IPGT & RA  IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT 		 09824985638

hasmukhjadav005@gmail.com 
 
Details of Ethics Committee  
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 having signs and symptoms of Shvitra (vitiligo). Patients having ages of 16 to 60 years. Patients with chronicity of less than 10 years. Wood’s lamp test positive. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gel prepared from Karnapatru Taila   Dose: QS for local application, once in a day at morning time Duration: 8weeks Follow up: 4weeks 
Intervention  Gel prepared from Shvitrahara Yoga  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  Female 
Details  • Patients having signs and symptoms of Shvitra (vitiligo).
• Patients having Sadhya Lakshana of Shvitra.
• Patients having ages of 16 to 60 years.
• Patients with chronicity of less than 10 years.
• Wood’s lamp test positive.
 
 
ExclusionCriteria 
Details  Patients having
• Chronicity more than 10 years.
• Serious cardiac, renal, hepatic diseases, major illness like IDDM, NIDDM, patches due to burning, chemical explosion, any other serious systemic illness.
• Gravid and lactating women.
• Lesions at region of Guhyanga (genital organ), Panipadatala (sole of palm and feet), Oshtha (lips), Aekanga (particular whole organ), Sarvanga (whole body).
• Patches with Raktaroma (reddish hair) & Samsakta (coalescent).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that the trial drugs will exert a significant action on Shvitra.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• By providing better effect on Shvitra, the drug will effect psycho-somatic level of patient and stress condition due to disease and enhance quality of life.  2 monts 
 
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 Enrollment (India)   15/08/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

SUMMARY:

The clinical study was aimed to evaluate clinical efficacy of gel prepared from Karpanpatru Taila and Shvitrahara Yoga 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 Karpanpatru gel and group B treated with Shvitrahara Yoga gel for local application once in a day in the morning with exposure to sunlight for 10 minutes for 2 months. In both groups 1gm of Bakuchi Churna and 1 gm of Vidanga Churna was administered orally along with honey and ghee as adjuvant. Total 111 patients were registered in the study, out of which 100 completed the treatment.

DEMOGRAPHIC DATA:

Maximum numbers of patients (78.57%) were from the age group of 16-30 years, male (58.18%), married (70.91%) and Hindu (92.73%) by religion. Maximum patients were having Vata Kapha Prakriti (54.96%), Madhyama Sara (63.03%), Madhyama Satva (66.67%), Madhyama Samhanana (63.96%). Madhyama Satmya (65.77%), Madhyama Vyayama Shakti (69.37%) and Madhyama Koshta (54.55%) was found in maximum patients.

            In Nidanas, Ahara dominant of Guru Guna (83.78%) and Snigdha Guna (50.45%) was found. Consumption of Viruddhahara (76.36%), Lavana + Dugdha (22.52%), Tila-Guda Sevana (57.66%), Amla Rasa + Dugdha (27.03%) and Lavana Rasa + Digdha (36.94%) was found maximum. In Vihara, Divaswapa (57.66%), Ajirna Bhojana (61.26%) and Usna Shita Kramaviruddha Sevana (28.83%) was found maximum whereas in Vegadharana (72.07%) was dominant.

            Maximum patients displayed duration of disease less than one year (30.63%) and negative family history of Shvitra (83.78%). Maximum patients showed symptoms of Swetabha Vaivarnyata (72.02%) and Mandalopatti (81.98%), Snigdha (65.77%), and Romavidhwansi (37.84%) of patches. Maximum patients (80%) were found white coloured patches, maximum patients (76.58%) were found more than 4 patches, (9.01%) patients were found having 1 patch. 72.97% were having Avyakta Lakshna as Purvarupa. All the patients had Svetabha Vaivarnata as a symptom, 97.29% of patients had Anagnidagdha as Sadhya symptoms. Asadhya Lakshana as Varshganottpana was found in 71.17% of the patients.

           

RESULTS:

Karpanpatru gel was seen to provide better results on area score (34.38%) in left side and (35.07%) in right side of the body which is statistically significant. In number of patches, (18.97%) in left side and (18.38%) in right side improvement was found which is statistically significant. In Mandalottapatti, (32.91%) in left side and (35.53%) in right side improvement was found which is statistically significant. Shvitrahara Yoga gel was seen to provide better results on area score (22.69%) in left side and (23.06%) in right side of the body which is statistically significant. In number of patches, (10.78%) in left side and (10.95%) in right side improvement was found which is statistically significant. In Mandalottapatti, (20.72%) in left side and (17.14%) in right side improvement was found which is statistically significant. In between groups there are no significant difference was observed so the both groups are effective in the symptoms of Shvitra.

 

Karpanpatru gel showed marked improvement in 14% patients, moderate improvement in 56% patients, mild improvement in 28% patients and 2% patients showed unchanged. None of patient showed complete remission or remarked. Shvitrahara Yoga gel showed marked improvement in 16% patients, moderate improvement in 50% patients, mild improvement in 32% patients and 2% patients showed unchanged. None of patient showed complete remission or remarked. No adverse drug reaction was found during study period or in follow up time.

            Considering the satisfactory remarks by patients & observed; it can be concluded that trial drug can be safe and used in cases of Shvitra (vitiligo). Further, trial may be attempted on the drug involving large sample size.

 
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