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CTRI Number  CTRI/2025/06/088566 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Exploring Ayurvedic Solutions for Hyperpigmentation: Comparing Palaash Oil and Chandan Bathing Powder 
Scientific Title of Study   Comparative Clinical Evaluation of Palaash Infused Sesame Oil and Chandan Herbal Bathing Powder in Hyperpigmentation 
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 JANKI M LUKHI 
Designation  Associate professor 
Affiliation  J S Ayurved Mahavidyalaya 
Address  PG Department of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad

Kheda
GUJARAT
387001
India 
Phone  8758810939  
Fax    
Email  jankilukhi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Vidhi Bapna 
Designation  Professor and HOD 
Affiliation  J S Ayurved Mahavidyalaya 
Address  PG Department of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad

Kheda
GUJARAT
387001
India 
Phone  9428972618  
Fax    
Email  drkumathvidhi29@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Vidhi Bapna 
Designation  Professor and HOD 
Affiliation  J S Ayurved Mahavidyalaya 
Address  PG Department of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad

Kheda
GUJARAT
387001
India 
Phone  9428972618  
Fax    
Email  drkumathvidhi29@yahoo.com  
 
Source of Monetary or Material Support  
Bilvam Jaganmaata Herbals Pvt Ltd, Anand-Umeta Road, Napad, Gujarat 
 
Primary Sponsor  
Name  J S Ayurved Mahavidyalaya 
Address  J S Ayurved Mahavidyalaya, college road, Nadiad 387001 
Type of Sponsor  Private medical college 
 
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 
Janki Lukhi  J S Ayurved Mahavidyalaya  Department of Dravyaguna, J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital, College Road, Kheda, Nadiad
Kheda
GUJARAT 		 8758810939

jankilukhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Chandan bathing powder, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Patient has to apply Chandan bathing powder after washing face
2Comparator ArmDrugOther than Classical(1) Medicine Name: Palaash infused sesame oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Patient has to apply Palaash infused sesame oil on washed face
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having signs of hyperpigmentation (dark patches) on face fulfilling the diagnosis will be included 
 
ExclusionCriteria 
Details  1.Patients having any other diseases like AIDS, STD, itching, wound, active acne, burning, eczema, dermatitis and other disorders which lead to fatal condition for the patients.
2.Birth marks and moles will be excluded.
3.Pregnant and lactating women.
4.Patients who are on corticosteroid drugs or immune suppressants and past history of steroidal use in the last 6 months.
5.Other concomitant skin disease occurring with allergic reaction of any other disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in signs of hyperpigmentation  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in clinical efficacy of Palaash infused sesame oil and chandan herbal bathing powder together and seperately  12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   17/07/2025 
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="1"
Months="6"
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   This study is Randomized clinical trial to evaluate the effect of Palaash infused sesame oil and chandan herbal bathing powder in hyperpigmentation. 60 patients fulfilling the inclusion criteria will be selected from OPD and randomly divided into three groups of 20 patients in each group. Medicine will be given to the patients of hyperpigmentation to apply externally on the affected part of the face twice a day. Duration of application will be of 3 months. Patients will be assessed before and after the treatment. 
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