| CTRI Number |
CTRI/2014/06/004681 [Registered on: 18/06/2014] Trial Registered Prospectively |
| 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 Dabur Oil formulation for hair fall reduction, strengthening of hair and overall improvement in hair & scalp condition in healthy Indian human subjects |
|
Scientific Title of Study
|
An efficacy evaluation of Dabur Ayurvedic Oil(DRDC/2014/014) for hair fall reduction, strengthening of hair and overall improvement in hair & scalp condition in healthy Indian human subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/DAAO/2014-01 Version 1.0 Date 27Apr2014 |
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 327/15 1st Main Road Cambridge layout Ulsoor Bangalore Karnataka India
Bangalore
KARNATAKA
560008
India |
| Phone |
8040917253 |
| Fax |
8041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs and Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Dabur Research and Development Centre
Dabur India Ltd
Plot No 22 Site IV Sahibabad Ghaziabad UP
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Sub Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
MS Clinical Research Pvt Ltd
327/15 1st Main Road Cambridge layout Ulsoor Bangalore Karnataka
Bangalore
KARNATAKA
560008
India |
| Phone |
8040917253 |
| Fax |
8041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited
22 Site IV Sahibabad Ghaziabad UP |
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Dabur Research & Development Centre
Dabur India Ltd
Plot No.22 Site IV Sahibabad Ghaziabad – 201 010
UP India
|
| Type of Sponsor |
Other [Healthcare and FMCG] |
|
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Details of Secondary Sponsor
|
|
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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 |
327/15 1st Main Road
Cambridge layout
Ulsoor
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 Hair strength Quality of Hair & Scalp |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbs & essential oil enriched Dabur formulation (DRDC/2014/014) |
The oil is multiple herbal and natural oil preparation to be tested for efficacy and safety in 12 weeks study.The oil has to be applied topically over hair and scalp.The Quantity of usage per application/dose is 5-10 ml approximately, depending on the length of hair.The subjects will be instructed to oil their hair twice a week only and wash their hair with the neutral shampoo on the next day of oiling. |
| Comparator Agent |
Marketed Ayurvedic Medicinal oil (DRDC/2014/025) |
The oil is a marketed oil formulation to be tested for efficacy and safety in 12 weeks study. The oil has to be applied topically over hair and scalp.The Quantity of usage per application/dose is 5-10 ml approximately, depending on the length of hair.The subjects will be instructed to oil their hair twice a week only and wash their hair with the neutral shampoo on the next day of oiling. |
| Comparator Agent |
Marketed Hair oil Formulation(DRDC/2014/026) |
The oil is marketed hair oil formulation to be tested for efficacy and safety in 12 weeks study. The oil has to be applied topically over hair and scalp.The Quantity of usage per application/dose is 5-10 ml approximately, depending on the length of hair.The subjects will be instructed to oil their hair twice a week only and wash their hair with the neutral shampoo on the next day of oiling. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Male and Female subjects in general good health.
•Subjects in the age group 18-65 years (both the ages inclusive).
•Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
•Female Subjects falling under Grade 2 - Grade 6 of hair loss severity grade evaluated as per standard photonumeric 6 point scale.
•Male subjects falling under Grade 3– Grade 6 of hair loss severity grade evaluated as per Norwood scale.
•Subjects willing to abide by and comply with the study protocol.
•Subjects who have not participated in a similar investigation in the past two weeks.
•Subjects complaining of hair fall and damage
•Healthy volunteers with no known allergy to any of the test ingredients as established by medical history.
•Subjects who show no sensitivity to test product.
•Subjects who are not on crash dieting.
•Subjects who agree not to change the brand of currently used hair colour, dye, treatment etc., if any during the study term.
•Subjects willing to refrain from any type of hair treatment like head massage, oil application (on scalp), perming, etc. during the study duration.
|
|
| ExclusionCriteria |
| Details |
•Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
•Subjects having any active scalp disease which may interfere in the study.
•Subjects who have treatments of cancer chemotherapy last 6 months before starting study or have a plan to do treatments of them during study terms.
•Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
•Subjects who have had hair transplant.
•Subjects who take pharmaceutical product which cause hirsutism.
•A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
•Subjects on oral medications which will compromise the study.
•Subjects who are pregnant lactating or nursing as established with medical history.
•Chronic illness which may influence the cutaneous state.
•Subjects participating in other similar cosmetic or therapeutic trial within last two weeks
•Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of heart and respiratory apparatus or any other serious medical illness
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To evaluate the efficacy of Dabur hair oil formulation in hair fall reduction strengthening of hair and overall improvement in hair & scalp condition in comparison to baseline.
•To evaluate the efficacy of Dabur Hair Oil formulation in hair fall reduction strengthening of hair and overall improvement in hair and scalp condition in comparison to marketed hair oil groups.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Safety of Investigational product by assessment of site application reaction by dermatologist and subjects. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/06/2014 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The study is double blinded, monocentre and comparator control study to assess the investigational product for hair fall reduction, hair growth, strengthening of hair and overall improvement in hair & scalp condition in healthy Indian human subjects. The study will be conducted for a period of approximately 12 weeks for each subject and will include a total of 9 visits i.e.1st visit will be a screening visit during. The eligible subjects will be enrolled. Visit 2, 4, 6 and 8 will be followed by Visit 3, 5, 7 and 9 respectively.The subjects who satisfy inclusion, exclusion criteria and sensitivity test will be enrolled after obtaining informed consent. A total of 90 male and female subjects with complain of hair fall, damaged hair and have not used hair oil for 2 weeks and aged between 18-65 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
|