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CTRI Number  CTRI/2024/12/078711 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Clinical trial on Skin related problem (leukoderma)]  
Study Design  Single Arm Study 
Public Title of Study   The use of Telosma pallida fruits in leucoderma  
Scientific Title of Study   A non-randomized, observational clinical study on formulation containing aqueous juice of Telosma pallida (Roxb.) Craib. Fruit for the treatment of white patches on the skin (leucoderma) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MAM Uni/IECHR/2024/40 date 24/04/2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Punitkumar R Bhatt 
Designation  Assistant Professor 
Affiliation  Faculty of Pharmacy, Dharmsinh Desai University 
Address  Faculty of Pharmacy Department of Pharmacognosy Room No. 307 Near Konkran Hanuman Mandir Opposite Aquenos Restaurant Uttarsanda Road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9725209039  
Fax    
Email  puns003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejal G Soni 
Designation  Professor and Dean 
Affiliation  Faculty of Pharmacy, Dharmsinh Desai University 
Address  Faculty of Pharmacy Department of Pharmaceutics Room No. 103 Near Konkran Hanuman Mandir Opposite Aquenos Restaurant Uttarsanda Road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9601904294  
Fax    
Email  tejalsoni.ph@ddu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Tejal G Soni 
Designation  Professor and Dean 
Affiliation  Faculty of Pharmacy, Dharmsinh Desai University 
Address  Faculty of Pharmacy Department of Pharmaceutics Room No. 103 Near Konkran Hanuman Mandir Opposite Aquenos Restaurant Uttarsanda Road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9601904294  
Fax    
Email  tejalsoni.ph@ddu.ac.in  
 
Source of Monetary or Material Support  
Material support include patients and infrastructural facilities from P D Patel Ayurved Hospital, Kayachhikitsa OPD, Room No. 102, Ground floor, J S Ayurveda Mahavidyalaya, College Road, Nadiad–387001 (Gujarat) India 
Monetory support from Dharmsinh Desai University, College road, Nadiad (Gujarat) 
 
Primary Sponsor  
Name  Dharmsinh Desai University 
Address  College Road, Nadiad-387001(Gujarat) India 
Type of Sponsor  Other [University] 
 
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 Punit Bhatt  P. D. Patel Ayurved Hospital  Kayachhikitsa OPD, Room No. 102, Ground floor, J S Ayurveda Mahavidyalaya, College Road, Nadiad – 387001
Kheda
GUJARAT 		 9725209039

puns003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research of the Maganbhai Adenwala Mahagujarat University, Nadiad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Juice of Telosma pallida fruits  Lotion or any other suitable formulation containing aqueous juice of fruits of Telosma pallida will be provided to the patients. Frequency - daily Total duration - 4 weeks Patients will be instructed to apply the sufficient amount of lotion on the white patches in the morning and expose the affected part in the sunlight for at least 20 to 30 minutes. At night, the lotion will be applied and left it overnight. In the morning, after taking bath, again morning application will be made. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female patient with confirmed leucoderma due to genetic or non-genetic reason can be included in the study.  
 
ExclusionCriteria 
Details  Female patients having pregnancy, breast feeding or post-delivery period.
Patients having evidence of extensive disease or any other treatment is continue.
Patients having patches or white spots due to chemical or burning hazard.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Skin color will be changed towards normal from hyperpigmentation.
This will be evaluated using the method given by Geel et al. (2020).
1. confetti-like depigmentation
2. Koebner phenomenon
3. hypochromic areas/borders

 		 Time-point is 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Size of the white patches or number of white patches will be reduced. The size of the white patches may be measured by putting a transparent plastic sheet on the skin & draw the area of the patch using pointed marker pen.
The scoring method to assess the effect of the treatment will be adopted.

 		 Time points will be, measurement at the end of the 1st 2nd 3rd & 4th week of the treatment. 
 
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   N/A 
Date of First Enrollment (India)   07/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This will be non-randomized, open label, clinical observational study. The study will be planned to generate the scientific data on the use of traditional medicine on leucoderma. 

Treatment protocol

Lotion or any other suitable formulation containing aqueous juice of fruits of Telosma pallida will be provided to the patients.

Patients will be instructed to apply the sufficient amount of lotion on the white patches in the morning and expose the affected part in the sunlight for at least 20 to 30 minutes. At night, the lotion will be applied and left it overnight. In the morning, after taking bath, again morning application will be made. 

Details of study procedures: 

All the patients, who fulfill the inclusion criteria, will select for the study from the in-patient and out-patient department of the P. D. Patel Ayurved Hospital, Nadiad. The patients will be instructed to take conventional treatment for leucoderma and do not apply any allopathy medicine during the treatment period. 

Patient having mild to moderate leucoderma will be kept as a treatment group. There is no control group in the present study. All the patients under the treatment group will be provided herbal formulation containing juice of fruits of Telosma pallida (lotion or any other suitable formulation) to apply on the affected area twice a day. 

Formulation to be given to the patient will be prepared at the Faculty of Pharmacy, Dharmsinh Desai University, Nadiad. 

All the patients will be clinically assessed before and after treatment. Signs and symptoms will be assessed by giving score. The grade score of signs and symptoms are prepared from us.

 
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