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CTRI Number  CTRI/2022/01/039493 [Registered on: 17/01/2022] Trial Registered Prospectively
Last Modified On: 24/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Haridradi tail in Acne and Pigmentation 
Scientific Title of Study   Clinical Study to assess the Efficacy and Safety of Haridradya Taila in Acne and Acne-induced Post-inflammatory Hyperpigmentation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumit Nathani 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Dept of Dravyaguna National Institute of Ayurveda Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  7665809886  
Fax    
Email  sumitnathani2@rediff.com  
 
Details of Contact Person
Scientific Query  
Name  Sumit Nathani 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Dept of Dravyaguna National Institute of Ayurveda Amer Road


RAJASTHAN
302002
India 
Phone  7665809886  
Fax    
Email  sumitnathani2@rediff.com  
 
Details of Contact Person
Public Query  
Name  Sumit Nathani 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Dept of Dravyaguna National Institute of Ayurveda Amer Road


RAJASTHAN
302002
India 
Phone  7665809886  
Fax    
Email  sumitnathani2@rediff.com  
 
Source of Monetary or Material Support  
Ms Ozone Pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Ms Ozone Pharmaceuticals Ltd 
Address  Ozone pharmaceuticals Ltd. 1, LSC, Block A-3, Janakpuri New Delhi- 110058  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Sumit Nathani  NIA Hospital  opd no 19, Department of Dravyaguna, Amer Road, Jaipur
Jaipur
RAJASTHAN 		 7665809886

sumitnathani2@rediff.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L810||Postinflammatory hyperpigmentation. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Haridradi tail, Reference: kshudr roga adhikar, Chakradutta, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients of either sex having mild to moderate facial Acne and mild to moderate acne induced PIH in clinical features.
ï‚· Patients of age between 18 - 45 years.
ï‚· Willing to take part in study and signing consent form 
 
ExclusionCriteria 
Details  1. With Present History of Skin Disease e.g. Psoriasis, Dermatitis, Vitiligo etc. related to face.
2. Person suffering from any infective or contagious skin disease
3. Under medication with antibiotics, antifungal and steroid during last one month.
4. Women on Oral contraceptives
5. Patients of known uncontrolled hormonal disease.
6. Any kind of diagnosed hereditary skin disorder.
7. Patient who had undergone any type of skin treatment like laser therapy in last 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary endpoint – Changes from baseline to the end of trial period in
ï‚· Individual lesion count and overall lesion count in Acne
 Overall grading of Acne in Investigator’s Global Assessment scale for Acne
 		 baseline, 4 weeks and 8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Endpoint
 –Changes from baseline to the end of trial period in Acne induced Post inflammatory hyperpigmentation severity scale
Safety/Tolerability Endpoints
ï‚· No visible Erythema, oedema, , scaling, dryness, burning, tingling stinging & itching
ï‚· Monitoring of adverse events throughout the course of the study 		 baseline, 4 weeks and 8 weeks
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   31/01/2022 
Date of Study Completion (India) 31/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Haridradya Taila is a classical preparation mentioned in kshudra
rogadhikar of Chakradatta.iii .
This taila is indicated in conditions of Acne as well as Hyper pigmentation of facial skin.
Present study aims to Evaluate and Document the Efficacy and Safety of local application of Haridradya Taila in treatment of Acne and post inflamatory Hyperpigmentation .
Primary Objective –
1. To assess the efficacy of local application of Haridradya taila for its effect on mild to moderate Acne.
Secondary objective –
1. To assess the efficacy of local application of Haridradya Taila for its effect on Acne induced post inflammatory Hyper pigmentation.
2. To assess the safety and tolerability of local application of Haridradya Taila.

Assessment 
For Efficacy  Investigator’s Global Assessment (IGA) Scale for Acne Severity (Annex 1)  Lesion counting (non inflammatory, inflammatory and total )  Acne induced Post inflammatory hyperpigmentation severity scale (Annex 2) For Safety and Tolerance  Tolerance (0 – 3 point assessment scale)iv : Erythema, edema, scaling, dryness, burning, stinging & itching Photographs at baseline & 8 weeks: Findings will be compared and analyzed for their significance to draw conclusion.
 
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