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CTRI Number  CTRI/2022/12/048288 [Registered on: 20/12/2022] Trial Registered Prospectively
Last Modified On: 03/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmectics]  
Study Design  Single Arm Study 
Public Title of Study   Clinical Study on Anti-Dandruff Herbal Shampoo 
Scientific Title of Study   A prospective, open label, one arm study to evaluate the safety and efficacy of LAFZ ETHNIC Tea Tree Oil & Lemon Refreshing Anti-Dandruff Herbal Shampoo in reduction of mild to moderate dandruff in healthy male or female volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/ADHS/2022, Version Number: 1.0, Date: 02-Nov-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058, Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058, Karnataka, India


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058, Karnataka, India


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Source of Monetary or Material Support  
Believe Pte. Ltd 2. Havelock Road, Unit 04 – 15, Singapore – 059763  
 
Primary Sponsor  
Name  Believe Pte. Ltd., 
Address  2. Havelock Road, Unit 04 – 15, Singapore – 059763  
Type of Sponsor  Other [Cosmetics Industry] 
 
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 Madan Mohan N T  Sigma Skin & Cosmetology Clinic   4th Model House St, Nagasandra circle, NR Colony, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA 		 9845074316

drmadan1969@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LAFZ ETHNIC Tea Tree Oil & Lemon Refreshing Anti-Dandruff Herbal Shampoo  Dosage form: Liquid, Usage: Wet your hair. Take a coin-sized dollop of shampoo and work it into a lather. Gently massage for 2-3 minutes from root to tip. Rinse thoroughly with plain water. Repeat this process once again if required. Application: Twice a week 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  • Healthy Indian male/female volunteer aged between 18-45 years (both inclusive)
• Willing to give Informed Consent
• Subjects diagnosed with of mild to moderate dandruff, assessed by mean total Adherent Scalp Flaking Score (ASFS) of 8 zones in the scalp.
• Willing to complete the study assessments/questionnaires.
• Willing to avoid usage of his/her own hair care products in controlling hair fall and dandruff for at least one week before the commencement and during this study.
 
 
ExclusionCriteria 
Details  • Pregnancy or breast feeding.
• Patients diagnosed with severe dandruff, Itching, flaking, pruritis and visible inflammation over face, retro auricular area, and the upper chest.
• Patients with inflammatory or infective scalp conditions.
• Patients with history of hypersensitivity to hair products
• Patients with mild to severe anaphylaxis reaction.
• Patients with pre existing severe systemic disease necessitating long term medication.
• Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation.
• History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
• Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Reduction of dandruff through Adherent Scalp Flaking Score (ASFS) from baseline to end of the study.  Day 0 to Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
• Consumer feedback will be obtained via a set of subjective questionnaires to evaluate the response towards the product.  Day 0 to Day 30 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/12/2022 
Date of Study Completion (India) 21/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After obtaining the Ethics committee approval subjects will be asked to visit the site. Informed consent will be administered to study volunteers, and after obtaining their consent in writing, the subjects will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. Subjects shall avoid using their own hair care products for at least one week before commencement of this study. Once the subjects are found eligible, they will be provided with IP and advised to use twice a week. They also will be advised to take the efficacy assessments like Videoscopy, Adherent Scalp Flaking Score and asked to fill the feedback questionnaire. The results obtained will be analyzed at the end of the trial. 
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