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CTRI Number  CTRI/2024/07/070086 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Conversion of haridradi oil to cream to study their effect in patients with melasma 
Scientific Title of Study   A comparitive pharmaceutico analytical and clinical evaluation of Haridradi taila and conversion to cream in the management of vyanga w.s.r to melasma 
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 Swathi K S 
Designation  PG Scholar  
Affiliation  ALN Rao Memorial Ayurvedic Medical College 
Address  Department of Rasashastra and Bhaishajya kalpana ALN Rao Memorial Ayurvedic Medical College Koppa, Chikmagalur Karnataka

Chikmagalur
KARNATAKA
577126
India 
Phone  8951300131  
Fax    
Email  swathi23ks@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagadeesha mayya A 
Designation  Professor 
Affiliation  ALN Rao Memorial Ayurvedic Medical College 
Address  Department of Rasashastra and Bhaishajya kalpana ALN Rao Memorial Ayurvedic Medical College Koppa, Chikmagalur Karnataka

Chikmagalur
KARNATAKA
577126
India 
Phone  9448525235  
Fax    
Email  jagdeeshmayya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swathi K S 
Designation  PG Scholar  
Affiliation  ALN Rao Memorial Ayurvedic Medical College 
Address  Department of Rasashastra and Bhaishajya kalpana ALN Rao Memorial Ayurvedic Medical College Koppa, Chikmagalur Karnataka

Chikmagalur
KARNATAKA
577126
India 
Phone  8951300131  
Fax    
Email  swathi23ks@gmail.com  
 
Source of Monetary or Material Support  
Department of Rasashastra and Bhaishajya kalpana, ALN Rao Memorial Ayurvedic Medical College, Koppa, Chikkmagalur, Karnataka-577126 
 
Primary Sponsor  
Name  Dr Swathi K S 
Address  Department of Rasashastra and Bhaishajya kalpana, ALN Rao Memorial Ayurvedic Medical College, Koppa, Chikkmagalur, Karnataka-577126 
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 Swathi K S  Aroor Laxminarayana Rao Memorial Ayurvedic Medical College Hospital  Department of Rasashastra and Bhaishajya kalpana, General OPD division, Room number 16
Chikmagalur
KARNATAKA 		 8951300131

swathi23ks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALN Rao Memorial Ayurvedic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Haridradi Cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: cream of quantity suffecient applied over face only
2Comparator ArmDrugClassical(1) Medicine Name: Haridradi Taila, Reference: Chakradatta , Route: Topical, Dosage Form: Taila, Dose: 8(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with clinical signs of Vyanga as per Ayurvedic classics will be included.
2. Patients between age group of 16 to 60 years will be selected for the study.
3. Patients irrespective of sex, religion and occupation will be selected for the study. 
 
ExclusionCriteria 
Details  1. Female on oral contraceptive pills, pregnant women, lactating women.
2. Hyperpigmentation since birth.
3. Any other condition interfering the course of treatment. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Number of circular lesions
2. Color of skin lesion
3. Area of distribution of skin lesion 		 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
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/ Phase 3 
Date of First Enrollment (India)   15/07/2024 
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="0"
Days="21" 
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 is a comparitive pharmaceutico analytical and clinical evaluation of Haridradi taila and conversion to cream for 21 days. This study comprise of two groups of 20 subjects with Vyanga. Study will be conducted in ALN Rao Memorial Ayurvedic Hospital in Koppa taluk, Chikmagalur district, Karnataka 577126, Primary outcome measure will be Number of circular lesions present over the face, Dark brown color lesion over the skin and Area of distribution of painless lesion. 
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