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CTRI Number  CTRI/2018/03/012284 [Registered on: 01/03/2018] Trial Registered Retrospectively
Last Modified On: 28/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmoceutical]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy evaluation of hair tonic in healthy human subjects 
Scientific Title of Study   A double blinded, randomized, placebo controlled study to evaluate the efficacy of hair tonic on healthy human subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/ITHS/2013-10,version 1.0 dated 25th Oct 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt.Ltd. 
Address  Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore

Bangalore
KARNATAKA
560025
India 
Phone  08040917253  
Fax  08041125934  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt.Ltd. 
Address  Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore


KARNATAKA
560025
India 
Phone  08040917253  
Fax  08041125934  
Email  mukesh.ramnane@mscr.in  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Ramnane  
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt.Ltd. 
Address  Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore


KARNATAKA
560025
India 
Phone  08040917253  
Fax  08041125934  
Email  mukesh.ramnane@mscr.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ITC R D Centre 
Address  Peenya Industrial Area, I Phase, Peenya, Bangalore 
Type of Sponsor  Other [FMCG] 
 
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 Mukesh Ramnane  MS Clinical Research Pvt Ltd  Room no. 1, hair evaluation department,Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore-560025
Bangalore
KARNATAKA 		 08040917253
08041125934
mukesh.ramnane@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom, Independent Ethics Committee, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1)Female subjects falling under Grade 2 – Grade-4 of hair loss severity grade. 2)Male subjects falling under Grade 2 to Grade 4 of hair loss severity grade. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair tonic  Dose: 7 ml of hair tonic per day Frequency: daily once Duration: 108 days for each subject. Mode of administration: Topical application 
Comparator Agent  Placebo  Dose: 7 ml of hair tonic per day Frequency: daily once Duration: 108 days for each subject. Mode of administration: Topical application 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)Female subjects falling under Grade 2 – Grade-4 of hair loss severity grade
2)Male subjects falling under Grade 2 to Grade 4 of hair loss severity grade
 
 
ExclusionCriteria 
Details  1)Subjects who are undergoing hair growth treatment 3 months before screening into the study.
2)Subjects who have scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluate the safety and efficacy of the investigational product in hair fall control or growth in comparison to baseline and placebo  1)Dermatological assessment of hair and scalp will be done on visits 1, 2, 4, 6, 8, 10, 12 and visit 14.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/12/2013 
Date of Study Completion (India) 28/05/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

·         In the study conducted with 100 enrolled subjects, over a period of 108 days to evaluate the efficacy of hair tonic on healthy human subjects. By imaging assessment, the improvement was seen highest in group A compared to group B.The products emerged to be overall safe with no clinically significant site application reaction reported during the study .Both group-A and group-B showed Improvement in flaking, itching and oiliness at visit11 compared to baseline. Scalling improved in two subjects out of four subjects reported at baseline. The severities of the dryness in one subject was resolved at visit 11. Subject perception on different parameters of hair was collected and assessed to be in favour of the both groups in hair fall rate and significant improvement in hair volume, hair growth rate and strength of the hair at visit 11. The group A showed significant improvement in reduction of hair fall on visit11 compared to group B by comb test (Hair with bulb) and the significant improvement was observed in the reduction of hair fall in both group A and group B by comb test (Hair without bulb). Phototrichogram assessment: There was an  improvement was observed in hair growth rate  at visit9vsvisit8 in both group A and Group-B at visit11 compared to visit 3 vs visit 2. 

ReRESULTS: The improvement in hair density was found to be higher in Group A compared to Group B. Both the groups also effective in scalp condition. Group A showed 100% normal scalp condition  and group B showed 96.3% normal scalp condition at visit 11.

 
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