| CTRI Number |
CTRI/2013/10/004079 [Registered on: 18/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An efficacy evaluation of hair oil for hair fall reduction, growth and strengthening of hair in healthy Indian human volunteers |
|
Scientific Title of Study
|
An efficacy evaluation of hair oil for hair fall reduction, growth and strengthening of hair in healthy Indian human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/DAHO/2013-03 version 1.0 dated 06th August 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 |
MS Clinical Research Pvt. Ltd, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore-560025, Karnataka India
Bangalore
KARNATAKA
560025
India |
| Phone |
8040917253 |
| Fax |
8041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Sub Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd |
| Address |
MS Clinical Research Pvt. Ltd, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore-560025, Karnataka, India
Bangalore
KARNATAKA
560025
India |
| Phone |
8040917253 |
| Fax |
8041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Dabur Research & Development Centre
Dabur India Ltd
Plot No.22, Site IV, Sahibabad, Ghaziabad
UP, India
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Dabur Research & Development Centre
Dabur India Ltd
Plot No.22 Site IV
Sahibabad Ghaziabad
Uttar Pradesh
India
|
| Type of Sponsor |
Other [Healthcare and FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
MS Clinical Research Pvt. Ltd
Mezzanine Floor
Classic Court
9/1 Richmond Road
Bangalore
Karnataka
India
Bangalore
KARNATAKA |
8040917253
8041125934
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM ETHICS COMMITTEE, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair fall Hair growth Strengthening of hair Overall hair condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coconut Oil |
Plain Coconut oil group will be evaluted for safety and efficacy |
| Intervention |
Herb enriched oil formulation (DRDC/2013/006) |
The Study will be conducted for a period of approximately 12 weeks for each subject and will be evaluated at baseline, 4, 8 and 12 weeks for dermatological safety and efficacy of hair oil. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects in general good health.
•Subjects in the age group 18-45 years (both the ages inclusive)
•Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
•Subjects complaining of hair loss, hair fall and damage
•Subjects willing to abide by and comply with the study protocol.
•Subjects who have not participated in a similar investigation in the past four weeks.
•Subjects who have not used hair oil in past 2 weeks
•Subjects who have not undergone any hair therapy in minimum 3 months
•Healthy volunteers with no known allergy to any of the test ingredients
•Subjects who show no sensitivity to test product.
•Subjects who are not on dieting.
•Subjects who are willing to refrain from using dyes/henna/hair treatment throughout the study.
•Subjects willing not to tie hair tightly.
|
|
| ExclusionCriteria |
| Details |
•Subjects who are undergoing hair growth or hair straightening or transplant treatment 3 months before screening into the study
•Subjects who have diseased Scalp conditions at the time of screening.
•Subjects who have alopecia areata
•Subjects who have treatments of chemotherapy within 6 months before starting study
•Subjects who have history of addiction or drug abuse or psychiatric disorder
•Subjects who use hairpiece during study terms
•Subjects on oral medications or suffering from chronic illness which will compromise the study.
•Subjects who are pregnant lactating or nursing
•Subjects participating in other similar cosmetic or therapeutic trial.
•Any underlying uncontrolled medical illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in hair growth,reduction of hair fall and strength of hair in comparison to baseline as determined by Dermatological assessment |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Safety of Investigational product by dermatologist and subjects.
•Improvement in overall condition of hair as assessed by dermatological and subject
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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)?
|
|
Brief Summary
|
The study is double blinded Coconut oil controlled study to assess the
investigational product (Herbs enriched oil -DRDC/2013/006) for the safety and
efficacy in hair fall treatment, growth and strengthening of hair in healthy
human Indian volunteers. The Study
will be conducted for a period of approximately 12 weeks for each subject and
will be evaluated at baseline, 4, 8 and 12 weeks. The subjects who satisfy
inclusion, exclusion criteria will be enrolled after obtaining informed
consent. A total of 60 male and female subjects with complain of hair fall,
damaged hair aged between 18-45 years (both the age inclusive) will be enrolled
in the study. Subjects will be asked to wash their hair on the day following oiling
(twice a week only) day with Neutral Shampoo which will be dispensed along with
the test product.
Subjects will be assessed for Dermatologist’s assessment for safety and
efficacy, Subject’s self assessment and Instrumental
assessment –Imaging, Strength of hair etc |