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CTRI Number  CTRI/2023/04/051369 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 21/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of shwitrarilepa and khadiradi kashaya in vitiligo 
Scientific Title of Study   A Comparative clinical study to evaluate the efficacy of Shwitrari lepa externally with or without Khadiradi Kashaya internally in cases of Shwitra w.s.r to Vitiligo 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidhya Arora 
Designation  P.G Scholar 
Affiliation  State Ayurvedic College Lucknow 
Address  P.G Department of Kayachikitsa State Ayurvedic College Tulsidas Marg ,Turiyaganj Lucknow, Uttar pradesh

Lucknow
UTTAR PRADESH
226001
India 
Phone  8630261978  
Fax    
Email  vidhyaarora2014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shachi Srivastava 
Designation  Reader  
Affiliation  P.G Department of Kayachikitsa State Ayurvedic College Lucknow 
Address  P.G Department of Kayachikitsa State Ayurvedic College Tulsidas Marg ,Turiyaganj Lucknow, Uttar pradesh

Lucknow
UTTAR PRADESH
226001
India 
Phone  8840833317  
Fax    
Email  drshachi09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidhya Arora 
Designation  P.G Scholar 
Affiliation  State Ayurvedic College Lucknow 
Address  P.G Department of Kayachikitsa State Ayurvedic College Tulsidas Marg ,Turiyaganj Lucknow, Uttar pradesh

Lucknow
UTTAR PRADESH
226001
India 
Phone  8630261978  
Fax    
Email  vidhyaarora2014@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College And Hospital Lucknow 226001 
 
Primary Sponsor  
Name  Dr Vidhya Arora 
Address  P.G Department of Kayachikitsa State Ayurvedic College Tulsidas Marg ,Turiyaganj Lucknow, Uttar pradesh 
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 Vidhya Arora  State Ayurvedic College Lucknow  P.G Department of Kayachikitsa State Ayurvedic College Tulsidas Marg ,Turiyaganj Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH 		 8630261978

vidhyaarora2014@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  (1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: shwitrari lepa, Reference: charak chikitsa7/170, Route: Topical, Dosage Form: Lepa Churna, Dose: 00(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Group-B-In this group patients will be treated with only SHWITRARI LEPA for local application only once in a day for the period of 3 month.
2Intervention ArmDrugClassical(1) Medicine Name: shwitrari lepa, Reference: charak chikitsa 7/170, Route: Topical, Dosage Form: Lepa Churna, Dose: 00(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: khadiradhi kashaya, Reference: yoga ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: In this group patients will be treated with SHWITRARI LEPA for local application once in a day and KHADIRADI KASHAYA with the prakshepa of BAKUCHI CHURNA (3 GM) in dose of 40 ml 12 hourly after meal for the period of 3 months. Ist Dose – Ist dose of Khadiradi Kashaya will be taken 2 hour before sun ex
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient willing for trial will first and foremost criteria.
2)Patient of switra having essential criteria with or without non essential criteria selected for the clinical trial.
3)Patient between age 21 to 60 years.
4) Patient having VETI SCORE between the range of 0.1- 22.2.
5)Patient with chronicity of less than 3 years. 
 
ExclusionCriteria 
Details  1)Hyperpigmented or depigmented skin lesion due to burn, injury,and infectious disease like Leprosy and
Pitriasis Alba etc.
2)Patient having hypopigmentation associated with sensory motor loss.
3) Patient having chronicity more than 3 years.
4)Patient having VETI SCORE>22.2.
5)Patient having hypopigmentation in lips (oushtha), genitals(Guha Pradesh), etc
6)Depigmentation due to endocrinal disorder.
7) Patient having pregnancy or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Aparisravi,sweta,rakt,tamravranmandal-non secretory white coppery,reddish lesion.
A. Rukshata of lession - Dryness at depigmented lesion
B. Daha in lesion - Burning sensation of skin at depigmented lesion.
C. Romadwansi in lesion - Getting hair fall at depigmented lesions.
D. Roma vivarnata of lesion- Change in the color of hairs at depigmented skin lesion.
E. Kandu in lesion – itching of skin at depigmented skin lesion. 		 D15,D30,D45,D60,D75,D90 (Days) 
 
Secondary Outcome  
Outcome  TimePoints 
VETI SCORE(Vitiligo Extent Tensity Index)  D15,D30,D45,D60,D75,D90(days) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/05/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary    TITLE OF THE STYDY-“A Comparative clinical study to evaluate the efficacy of Shwitrari lepa externally with or without Khadiradi Kashaya internally in cases of Shwitra w.s.r to Vitiligo”.

 NEED OF THE STUDY -Patients suffering from Vitiligo are not only affected physically but also suffer from social stigma. 
 -It affects the quality of life of an individual as it leaves behind cosmetic disfigurement. 
 -Overall prevalence of Vitiligo is about 1% affecting equally men and women and 4% prevalence in Indian population. 
 -The most potent form of Psoralen i.e. 8-Methoxy psoralen which is mainly used in modern medicine has so many side effects viz phototoxicity , hyperpigmentation, and solar elastosis. 
 -Ayurveda has different approach to the understanding and treatment of Shwitra (Vitiligo) which requires extensive research.

 AIM-To establish the comparative role of Shwitrari Lepa and Khadiradi Kashaya (Kwath) in cases of Shwitra (Vitiligo) 
 
OBJECTIVE
 1)PRIMARY OBJECTIVE-.To assess the efficacy of Shwitrari lepa and Khadiradi Kashaya in cases of Shwitra w.s.r to Vitiligo. 
2)SECONDARY OBJECTIVE .To assess safety of trial drug .
 .To assess the benefit of Sthanic prayoga of lepa. .
To assess the effectiveness of trial drug in improving the quality of life in patients of Shwitra. 

 PLAN OF STUDY-For the purpose of clinical trial, the patient fulfilling the clinical criteria for diagnosis of Shwitra will be randomly selected irrespective of their sex , caste , and religion from OPD of state Ayurvedic College and Hospital , Lucknow and referred cases from other hospitals. A careful history ,physical examination and necessary investigation will be performed as per performa prepared for the present trial.

 TYPE OF STUDY-Phase-2 Rational, Parallel group Study. 

RANDOMIZATION- Computer generated random table.

 SAMPLE SIZE-Minimum 40 patient of Switra w.s.r to vitiligo From OPD and other nearby hospital will be selected according to the Inclusion and Exclusion criteria and randomly divided into two groups i.e-Group A and Group B with approximately 10% drop out .

 DIAGNOSTIC CRITERIA-The parameters for the diagnosis will completely based on classical signs and symptoms. 

 1)ESSENTIAL CRITERIA(OBJECTIVE CRITERIA)
 A .Aparisravi,sweta,rakt,tamravranmandal-non secretory white coppery,reddish lesion.
 B .VETI SCORE between the range of 0.1-22.2 . 
 2)NON ESSENTIAL CRITERIA-(SUBJECTIVE CRITERIA) Rukshata of lesion, Daha in lesion, Romadwansi in lesion ,Roma vivarnata of lesion ,Kandu in lesion. .

 INCLUSION CRITERIA 1)Patient willing for trial will first and foremost criteria. 2)Patient of switra having essential criteria with or without non essential criteria selected for the clinical trial. 3)Patient between age 21 to 60 years. 4) Patient having VETI SCORE between the range of 0.1- 22.2. 5)Patient with chronicity of less than 3 years.
 EXCLUSION CRITERIA 1)Hyperpigmented or depigmented skin lesion due to burn, injury,and infectious disease like Leprosy and Pitriasis Alba etc. 2)Patient having hypopigmentation associated with sensory motor loss. 3) Patient having chronicity more than 3 years. 4)Patient having VETI SCORE>22.2. 5)Patient having hypopigmentation in lips (oushtha), genitals(Guha Pradesh), etc 5)Depigmentation due to endocrinal disorder. 6) Patient having pregnancy or lactating women. 
 CRITERIA FOR WITHDRAWAL 1) Acute skin allergies. 2)Any other fatal side effect. 3)Increase in size of lesion or number of lesion during treatment. 4)Personal matter/any other difficulties/not willing to continue trial. 
 LABORATORY INVESTIGATIONS 1)Routine:- Hematological investigation,Urine,L.F.T,K.F.T,Lipid profile,Blood sugar,Thyroid Function test. 2) Specific investigation-Photography of lesion with same Camera ,Distance, natural sun light , Position and background,Skin smear(if possible),Serum copper level(if possible),Vit B12 level (if possible) 

GROUPING OF PATIENTS
 Group-A- In this group patients will be treated with SHWITRARI LEPA for local application once in a day and KHADIRADI KASHAYA with the prakshepa of BAKUCHI CHURNA (3 GM) in dose of 40 ml 12 hourly after meal for the period of 3 months. -Ist Dose – Ist dose of Khadiradi Kashaya will be taken 2 hour before sun exposure. -IInd dose -IInd dose of Khadiradi Kashaya will be taken after 12 hours of first dose. 

 Group-B-In this group patients will be treated with only SHWITRARI LEPA for local application only once in a day for the period of 3 month. 

 TREATMENT SCHEDULE WITH DOSE & DURATION: 
 1)SHWITRARI LEPA-Depending upon the area of involvement of disease lepa will be applied once a day 10 minutes before sun exposure for maximum upto 30 minutes.
 2)KHADIRADI KASHAYA- 40 ml of the Kashaya 12 hourly after meal for the period of 3 months. -Ist Dose – Ist dose of Khadiradi Kashaya will be taken 2 hour before sun exposure. -IInd dose -IInd dose of Khadiradi Kashaya will be taken after 12 hours of first dose.

 PERIOD OF STUDY- Total duration of clinical trial will be 90 days. 
 FOLLOW UP PERIOD- Studies of all registered cases will be done at fortnight interval for a period of 3 months with trial drug and one month without drug to access the condition of patient and to observe any other side effect .
 DURING TREATMENT – D15,D30,D45,D60,D75,D90. 
 AFTER TREATMENT-30 days without treatment (after the trial is completed) 

CRITERIA FOR ASSESSMENT OF RESULT-The total effect of the therapy will be assessed considering the following criteria. 1)RELIVED - If improvement in subjective and objective parameters >75% of the initial score. 2)IMPROVED Moderate -if improvement in subjective and objective parameters 50%-74% of the initial score. Mild - If improvement in subjective and objective parameters 25% to 49% of the initial score. 3)UNCHANGED - Less than 25% improvement in subjective and objective parameters . 4)WORSENED RESPONSE - If increased in number and size of patches,hypopigmentation/depigmentation of normal skin and increased in other associated feature or develops complications. 
 CONCLUSION & STATISTICAL ANALYSIS OF THE TRIAL-Conclusion will be drawn after complete assessment of the patients with each and every follow up by using standard statistical methodology . For deciding the effectiveness of the trial drugs in both the group “ paired t-test” will be applied as the sample size is small . 
 
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