Comparative Efficacy of three Hair Oil formulations in healthy adult females

Phase 2

Completed

• Registration Number: CTRI/2017/01/007645
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

a.Female subjects aged 18 to 35 years and capable of providing written informed consent. With complaint of mild to moderate dandruff and hair fall

b.Female subjects with at least shoulder length hair.

c.Regular (at least twice a week) user of a commercially available brand of hair oil and shampoo.

d.The female subject should be a healthy individual.

e.The female subject should be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator.

Exclusion Criteria

a.Pre-existing hair disease or scalp disease other than Hair fall (with no obvious underlying illness).

b.Concomitant medications or treatments affecting the hair (e.g.: Minoxidil application,

Chemotherapy)

c.A positive urine pregnancy test

d.Subjects not willing to provide informed consent.

e.Use of styling tools,hair dyes,perms etc.

f.Excessive exposure to sun,chemicals in pools (not more than once in a week), or salt in oceans .

g.Pregnant, lactating or sexually active women with childbearing potential who are not

using a medically accepted birth control method.

h.History or presence of cardiovascular , respiratory, hepatic, renal, gastrointestinal ,

endocrinological , neurological disorders.

i. History or presence of drug addiction.

j.History of frequent and severe headache.

k.Subjects who are known to have serum hepatitis, or who are carriers of the Hepatitis B surface antigen (Hbs-Ag),or Hepatitis C antibody or who are HIV positive.

I. Participation in another clinical trial in less than 12 weeks before the screening visit. m.Known allergy I intolerance to the investigational product.

n.Any clinical conditions that in the opinion of the Investigator would make the subject unsuitable for the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of hair oil H0/701 hair oil compared to H0/702 and H0/703 in healthy adult female subjects.Timepoint: Day 0 (baseline), 14, 28, 42, 56

Secondary Outcome Measures

Name	Time	Method
overall subject safetyTimepoint: Day 0 (baseline), 14, 28, 42, 56