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CTRI Number  CTRI/2016/04/006785 [Registered on: 01/04/2016] Trial Registered Retrospectively
Last Modified On: 21/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   DHATRYADI KWATHA ORALLY AND FALGU PATRA SWARASA APPLICATION WITH AND WITHOUT VIRECHANA IN SHWITRA(VITILIGO) 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY ON DHATRYADI KWATHA AND EXTERNAL APPLICATION OF FALGU PATRA SWARASA ALONG WITH VIRECHANA IN THE MANAGEMENT OF SHWITRA W.S.R. TO VITILIGO 
Trial Acronym  SHWITRA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR RAJDIP RAO 
Designation  PG SCHOLAR DEPARTMENT OF PANCHAKARMA 
Affiliation  INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  DEPARTMENT OF PANCHAKARMA IPGT AND RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
46 PG BOYS HOSTEL IPGT AND RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India 
Phone  8460132141  
Fax    
Email  rajdip.rao@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anup Thakar 
Designation  Professor and HOD 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof P K Prajapati 
Designation  Professor and Director 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9978403323  
Fax    
Email  prajapati.pradeep1@gmail.com  
 
Source of Monetary or Material Support  
IPGT & RA GAU JAMNAGAR GUJARAT INDIA 361008 
 
Primary Sponsor  
Name  IPGT and RA GAU JAMNAGAR GUJARAT 
Address  DEPARTMENT OF PANCHAKARMA IPGT and RA GAU JAMNAGAR GUJARAT INDIA 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 
DR RAJDIP RAO  IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT  DEPARTMENT OF PANCHAKARMA IPGT & RA GUJARAT AYURVEDA UNIVERSITY JAMNAGAR 361008
Jamnagar
GUJARAT 		 8460132141

rajdip.rao@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Depigmented macules. Hypo pigmented skin lesions. classical symptoms of Shwitra , (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dhatraydi kwatha and external application of Falgu patra swarasa  Internal Drugs: Dhatryadi kwatha- 40ml twice a day. External: Falgu patra swarsa application Q.S. Duration: 6 weeks Follow up: 4 weeks  
Intervention  Virechana karma followed by Dhatrayadi kwatha and external application of Falgu patra swarasa  Classical Virechana karma Internal Drugs: Dhatryadi kwatha- 40ml twice a day. External: Falgu patra swarsa application Q.S. Duration: 6 weeks Follow up: 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having sign and symptoms of Shwitra (Vitiligo).
2. Patients indicated for Virechana as per Ayurvedic classics.
3. If the patients to withdrawn ongoing medications like systemic corticosteroids, systemic or local photosensitizers or drugs scientifically proven to cause hyperpigmentation on local application or systemic administration will be included. Washout period after quitting will be for 7 days.
 
 
ExclusionCriteria 
Details  1.Patients having chronic condition, more than 10 years
2.Patients contraindicated for Virechana as per Ayurvedic classics.
3.Patients having all other de-pigmentory disorders.
4.Patients having serious cardiac, renal, hepatic diseases.
5.Patients having major illness like IDDM, NIDDM which are poorly controlled and any other systemic diseases.
6.Patches due to burning, chemical explosion etc.
7.Located at region of Guhya(Genital region), Panitala(Foot soles and Hand soles), Oshtha (Lips), Aekanga, Sarvanga(whole body).
8.Patches with Raktaroma & sansakta.
9.Patients with known drug hypersensitivity, photosensitivity,
10.Pregnant and lactating women.
11.Patients with ongoing medications like systemic corticosteroids, systemic or local photosensitizers or drugs scientifically proven to cause hyperpigmentation on local application or systemic administration.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
ASSESSMENT WILL BE DONE ON THE SPECIALLY DESIGNED PROFORMA OR ASSESSING SIGN AND SYMPTOMS IN SCORING PATTERN  2 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
ASSESSMENT WILL BE DONE ON THE SPECIALLY DESIGNED PROFORMA OR ASSESSING SIGN AND SYMPTOMS IN SCORING PATTERN  2 MONTHS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   23/02/2016 
Date of Study Completion (India) 31/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

1.      Shwitra characterized by white patches which effectively resembles and represents Vitiligo according to modern science.

2.      Most of the patients of Shwitra were more concerned about Shweta Mandala (hypo pigmented or white coloured patches) instead of any other symptoms of Shwitra and visit hospital for same.

3.      Viruddha Ahara (incompatible diet) like milk with salt, milk with sour foods, excess taking of fermented foods were observed in most of patients of Shwitra.

4.      Virechana, Dhatryadi Kwatha and External application of Phalgu-patra swarasa (Group A) therapy showed better results in cardinal symptoms like colour, number, area and size of patches than Dhatryadi Kwatha and External application of Phalgu-patra swarasa (Group B) therapy.

5.      Group B showed better effect on Mandalotpatti and Rukshata like symptoms.

6.      Group A presented better repigmentation response on face, neck, dorsa of hands, elbows and ankles and didn’t respond on distal extremities and on Sansrishta (mixed one another patches). 

7.      Virechana group showed better result in VASI, VETF and VETI score as compare to Shamana group.

8.      Group A exhibited better percentage fraction than Group B on Quality of life parameters i.e. DLQI, VitiQoL and VIS-22.

9.      Results of Group B indicated that effective inhibition of the inflammatory response alone might not be sufficient to induce spontaneous repigmentation in Shwitra (Vitiligo).

10.  Overall 60% patients showed moderate improvement, 33.33% patients showed marked improvement and 6.67% showed mild improvement in Group A. Overall 66.67% patients showed mild improvement while 33.33% patients showed moderate improvement in Group B.

11.  Therapeutically, both the groups (Group A- Virechana, Dhatryadi Kwatha and External application) and Group B- Dhatryadi Kwatha and External application) provided considerable symptomatic relief. However, Group A (Virechana group) was found to be relatively more effective in the management of majority of the symptoms and on quality of life.

Hence, the null hypothesis is rejected and alternative hypothesis is accepted i.e. “Dhatryadi Kwatha and external application of Phalgu-patra swarasa are more effective along with Virechana in the management of Shwitra (Vitiligo)”.

 
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