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CTRI Number  CTRI/2025/03/082197 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to Evaluate the Effectiveness of Gunja-Chitraktwak Lepa(a herbal paste) and Dhatryadi Kwath(a herbal decoction) in treating Shvitra (a Depigmentation Skin Condition). The study will help determine whether these traditional remedies can support skin repigmentation and improve the condition. 
Scientific Title of Study   Randomised open controlled clinical study to evaluate the efficacy of Gunja-Chitraktwak lepa for external use along with Dhatryadi kwath for internal use in Shvitra vyadhi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishnavi Rajan Dixit 
Designation  P. G. Scholar  
Affiliation  Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli  
Address  OPD no 17 Kayachikitsa department Ground floor Yashwant Ayurvedic College Post Graduate Training and research centre Kodoli Tal Panhala Dist Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9145036615  
Fax    
Email  vaishnavidixit2510@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suryakiran Parashuram Wagh 
Designation  Professor 
Affiliation  Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli 
Address  OPD no 17 Kayachikitsa department Ground floor Yashwant Ayurvedic College Post Graduate Training and research centre Kodoli Tal Panhala Dist Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9822846910  
Fax    
Email  suryakiran_wagh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Rajan Dixit 
Designation  P. G. Scholar  
Affiliation  Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli  
Address  OPD no 17 Kayachikitsa department Ground floor Yashwant Ayurvedic College Post Graduate Training and research centre Kodoli Tal Panhala Dist Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9145036615  
Fax    
Email  vaishnavidixit2510@gmail.com  
 
Source of Monetary or Material Support  
Manakarnika Aushadhalaya Sadashiv Peth Pune 411030 
 
Primary Sponsor  
Name  Dr Vaishnavi Rajan Dixit  
Address  CTS 4302 Plot B 4 Sushilanand Hsg Society Opp Prathamesh Plaza Near Aswaad misal Saswad Tal- Purandar Dist- Pune 412301 
Type of Sponsor  Other [Self ] 
 
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 Vaishnavi Rajan Dixit  Yashwant Dharmartha Rugnalaya Kodoli  OPD no 17 Kayachikitsa department Ground floor Yashwant Ayurvedic College Post Graduate Training and research centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA 		 9145036615

vaishnavidixit2510@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Yashwant Ayurvedic College PGT and RC Kodoli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pralepa, प्रलेप (Procedure Reference: Sharangadhar Samhita, Madhyam Khanda, Chapter 11, Procedure details: Lepa churna should be mixed in gomutra as per requirement. External application of freshly prepared lepa twice daily on the affected area & keep it for 20 minutes. Thickness of Varnya lepa should be 1/2 anguli as per Sharangdhar Samhita.)
(1) Medicine Name: Gunja-Chitraktwak lepa, Reference: Bhaishajya Ratnavali Kushtharog Adhyaya, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Duration: 90 Days
2Comparator ArmDrugClassical(1) Medicine Name: Dhatryadi kwath, Reference: Bhaishajya Ratnavali Kushtharog Adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Only choorna to prepare kwath will be supplied to the patients by principal investigator. Kwath preparation procedure will be explained to the patients and patients will be told to prepare the kwath freshly by themselves.
3Intervention ArmDrugClassical(1) Medicine Name: Dhatryadi Kwatha, Reference: Bhaishajya Ratnavali Kushtharog Adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Only choorna to prepare kwath will be supplied to the patients by principal investigator. Kwath preparation procedure will be explained to the patients and patients will be told to prepare the kwath freshly by themselves.
4Comparator ArmProcedure-pralepa, प्रलेप (Procedure Reference: Sharangadhar Samhita,Madhyam Khanda, Chapter 11,, Procedure details: Lepa churna should be mixed in gomutra as per requirement. External application of freshly prepared lepa twice daily on the affected area & keep it for 20 minutes. Thickness of Varnya lepa should be 1/2 anguli as per Sharangdhar Samhita.)
(1) Medicine Name: Kakodumbaradi lepa, Reference: Charak Chikitsa 7/170, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients having signs and symptoms of Shvitra. 2) Chronicity less than 1 year. 
 
ExclusionCriteria 
Details  1) Patients not fulfilling the above criteria.
2) All that Shvitra having Asadhya lakshana as per mentioned in ayurvedic texts like Varshaganotpannam, Agnidagdhaja.
3) H/O Chronic illness like Diabetes Mellitus, Atopic dermatitis, other serious systemic illness.
4) Gravid and lactating women.
5) Lesions at Guhyanga (genital organ), Panipadatala (palms and soles), Oshtha (lips), Ekanga (involving an entire organ), Sarvanga (generalized lesions)
6) Patches with Raktaroma (Reddish hair) and Samsakta (Coalescent) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Gunja-Chitraktwak lepa along with Dhatryadi kwatha in management of Shvitra.  90 days interval 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study the mode of action of Gunja-Chitraktwak lepa.
2) To study the mode of action of Dhatryadi kwatha.
3) To study the mode of action of Kakaodumbaradi lepa.
4) To study about Shvitra in detail according to Ayurveda.
5) To assess the subjective and objective parameters according to assessment criteria.
5) To achieve the outcome of study in 90 days 		 90 days interval 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   30/03/2025 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   1) Title of study: Randomized open controlled clinical study to evaluate the efficacy of Gunja-Chitraktwak lepa for External use along with Dhatryadi kwath for Internal use in Shvitra vyadhi. 
2) Study Objective: Primary Objective- To study the efficacy of GUNJA-CHITRAKTWAK LEPA and DHATRYADI KWATH in Shvitra.
                                  Secondary Objectives- 1. To study the effect of GUNJA-CHITRAKTWAK LEPA for External applicaion and DHATRYADI KWATH for Internal use in signs and 
                                  symptoms like colour of patch, exudation, itching, burning sensation, snigdhatva or rukshatva, parushya, loss of hair follicles, size of patch, etc.
                                  2. To study etiopathology of Shvitra in detail.
                                  3. To assess various causes responsible for Shvitra in study population as well as according to review.
                                  4. To achieve the outcome of study in 90 days.
3) Study design: Type of study- Randomized open controlled, parallel 
                               Method of Randomization- Lottery method 
                                                                 
                                                                                                                 Screening of patients in study population      
                                                                                                                          /                                                 
                                                                                                        Inclusion criteria                           Exclusion criteria
                                                                                                                       |                                                          |
                                                                                              Informed and written consent                        Excluded
                                                                                                                       |
                                                              Divided in two groups Group A and Group B (by Lottery method)
                                                                         /                                                                                 
                                                       Trial Group (GROUP A)                                               Control Group (GROUP B)
                                                                         |                                                                                     |
                                     Gunja-Chitraktwak lepa and Dhatryadi kwath           Kakodumbaradi lepa and Dhatryadi kwath 
                                                                                                                                   /
                                                                                                          Initial assessment
                                                                                                                         |
                                                                                              Dietary modification adviced to all
                                                                                                                         |
                                                    Assessment of subjective and objective parameters on 30th, 60th and 90th Day
                                                                                                                         |
                                                                                                             Data collection
                                                                                                                         |
                                                                                                   Statistical analysis of data
                                                                                                                         |
                                                                            Discussion, Results, Conclusion and Summary of Study
4) Study Population: The regular and camp patients coming to OPD of Kayachikitsa Department.
                                     Patients having Shvitra of age group- 16 years to 60 years irrespective of gender.
                                     Time of study per patient- 90 days
                                     Follow up on 30th, 60th and 90th day.
    Inclusion Criteria- 1. Patients having Signs and Symptoms of Shvitra.
                                    2. Age group between 16-60 years
                                    3. Chronicity less than 1 year
    Exclusion Criteria- 1. Patients not fulfilling the above criteria
                                     2. All that Shvitra having Asadhya lakshana as per mentioned in Ayurvedic texts like Varshaganotpannam, Agnidagdhaj.
                                     3. H/o Chronic illness like Diabetes Mellitus, Atopic dermatitis, other serious systemic illness.
                                     4. Gravid and lactating women.
                                     5. Lesions at Guhyanga (genital organ), Panipadatala (palms and soles), oshtha (lips), Ekanga (involving an entire organ), Sarvanga (generalized lesion)
                                     6. Patches with Raktaroma (reddish hair), and Samsakta (coalescent)
5) Intervention: Intervention drug: Gunja-Chitraktwak lepa along with Dhatryadi kwath. 
6) Control group drug: Kakodumbaradi lepa and Dhatryadi kwath.
7) Treatment details: 
 Groups Trial group  Control group 
 No. of subjects 15  15 
 Drug Gunja-Chitraktwak lepa  Dhatryadi kwath  Kakodumbaradi lepa  Dhatryadi kwath 
 Time Twice in a day Twice in a day Twice in a day Twice in a day
 Application time Until the lepa gets dry (20 min)  Until the lepa gets dry (20 min) 
 Quantity 1 gm 40 ml 1 gm 40 ml
 Total duration 90 days 90 days 90 days 90 days
 Route of administration Local application Oral Local application Oral
 Follow up On 30th, 60th, 90th day  On 30th, 60th, 90th  Parisravi (discharge)

8) Assessment criteria: 
     Subjective parameters- Parisravi (discharge)
                                               Kandu (itching)
                                               Daha (burning sensation)
                                               Rukshatva (dryness)
                                               Romadhvansi (loss of hair follicles)
     Objective parameters- Number of mandala
                                             Size of mandala
                                             Colour of patches
                                             Chronicy of patches
9) Total effect of therapy: 
 Effect of therapy Percentage of improvement
 Cured 100%
 Marked improvement 75% and above relief in signs and symptoms
 Moderate improvement >50% to <75% relief in signs and symptoms
 Mild improvement >25% to <50% relief in signs and symptoms
 Unchanged <25% relief in signs and symptoms

10) Location: OPD no. 17 Kayachikitsa Department, Yashwant Ayurved College PG teaching and RC, Kodoli, Kolhapur, Maharashtra, 416114
                                             
                                               
 
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