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CTRI Number  CTRI/2019/09/021018 [Registered on: 02/09/2019] Trial Registered Prospectively
Last Modified On: 06/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [safety and efficacy study]  
Study Design  Other 
Public Title of Study   Safety and efficacy study of a Hair Care Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and Oil Replacement used in combination in treatment of hair fall control  
Scientific Title of Study   An open-label, single-center, safety and efficacy study of a Hair Care Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and Oil Replacement used in combination in treatment of hair fall control in healthy adult human subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KLS19-DAB-159 Version: 00, Dated 07 Aug 19  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nayan.patel@karmiclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549


GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nayan.patel@karmiclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Tamboli 
Designation  HOD-Consumer Research 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  maheshvari.tamboli@karmiclifesciences.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Dabur International Limited 
Address  P. O. Box 16944 Jebel Ali Free Zone, Dubai - U.A.E. Phone#: (971-4) 8817756, 8817689 Fax: (971-4) 8817732 
Type of Sponsor  Other [Private Manufacture] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  Cliantha Research  Consumer Research Department, Garden View Corporate House No. 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 91 7966219549
Ahmadabad
GUJARAT 		 9909013286
07966219549
nayan.patel@karmiclifesciences.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  18 to 65 years adult female subjects having 50 to 100 hair fall per day. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Hair Oil 2. Shampoo 3. Hot Oil (Hamamzaith) 4. Oil Replacement  1. Once in a week 2. Thrice in a week 3. Once in a week 4. Thrice in a week 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1) Age: 18 to 65 years (both inclusive) at the time of consent.
2) Sex: Healthy non-pregnant/non-lactating females.
3) Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit.
4) Subjects generally in good health.
5) Subjects having 50 to 100 hair fall per day.
6) Females with 50 count of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before treatment.
7) Subjects willing to give written informed consent and willing to follow study procedure.
8) Subjects who have used other marketed product for hair fall control in the past.
9) Subjects willing to refrain from any other treatment for the main indications for which the study test products are being given during the course of the study.
10) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair fall treatment/ hair products other than the test product for the entire duration of the study.
11) Willing to use test product throughout the study period. 
 
ExclusionCriteria 
Details  1) Subjects with history of severe Hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
2) History of any dermatological condition of the scalp other than hair loss and/or dandruff.
3) History of prior use of scalp hair growth treatment within 3 months.
4) History of any prior hair growth procedures (e.g., hair transplant or laser).
5) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
6) History of alcohol or drug addiction.
7) Subjects using other marketed hair fall control products during the study period.
8) Subjects who have plans of shaving of scalp hair during the course of the study.
9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
11) Subjects having a history or present condition of an allergic response to any cosmetic products.
12) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
13) Pregnant or breastfeeding or planning to become pregnant during the study period.
14) History of chronic illness which may influence the cutaneous state.
15) Subjects participating in other similar cosmetic or therapeutic trial within last two weeks. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean percentage change in hair fall reduction after 12 weeks of treatment from Baseline on Day 01 before treatment to Day 21, Day 45, Day 63 and Day 90 (±2 Days) after treatment using 60-S Hair count technique.  Baseline on Day 01 before treatment, after treatment on Day 21, Day 45, Day 63 and Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in general appearance of hair (Hair Volume, Hair Density, Hair Plasticity, Hair strength, Hair smoothness, Hair Oiliness, Shininess), Change in appearance of scalp skin (itchiness, redness, roughness and scaliness of scalp), Change in hair shine, hair strength & hair frizziness, Measuring overall quality of hair i.e. Hair Thickness, Hair Density and Scalp condition & Product perception.
2. Measuring hair growth phase i.e. % anagen hairs, % telogen hairs and A:T ratio.
 		 1. Baseline Day 01 before treatment, after treatment on Day 21, 45, 63, 90.
2. Baseline Day 01 before treatment, after treatment on Day 90.
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/09/2019 
Date of Study Completion (India) 04/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

An open-label, single-center, study to evaluate the safety and efficacy of a Hair Care Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and Oil Replacement used in combination in treatment for hair fall control in healthy adult human subjects.

Total study duration is 90 days i.e. 3 Months. 
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