An Safety Study to evaluate the effectiveness of Kalimera hair oil on Human hair health for hair Growth, Hair Strength, Hair Lustrous and Dandruff preventio

Not Applicable

Completed

• Registration Number: CTRI/2019/05/019022
• Lead Sponsor: BioVein Innovations Solutions Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-02
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Male and female volunteers 18-50 years old, inclusive.

Able to provide informed consent after risks and benefits of the study have been explained.

Be willing to undergo all study procedures

Ability to communicate effectively with study personnel.

Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study; also agrees to abstain from shaving the head during the course of the study

Exclusion Criteria

Women who are pregnant or lactating.

Subjects who took any medicine which can affect the hair growth in recent 3 months.

Subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.

Subjects with scalp / skin infection, history of hypersensitivity to study products which may interfere in the study.

Received any other investigational medicinal therapy within 30 days and topical therapy within 7 days prior to screening

Patient suffering from any active general illness or have history of any general illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of kalimera hair oil in the improvement of Hair growth (Trichoscan technique), Hair strength (Universal Tensile Testing Machine (UTM) and Improvement in scalp dandruff (By adherent scalp flaking score).Timepoint: day0 day90

Secondary Outcome Measures

Name	Time	Method
Compare the changes in Manual assessment of hair loss by One min (60sec) comb test or hair count test from screening visits to end of visits. <br/ ><br>Self-assessment of hair lustrous(shininess) by subjective questionnaires atTimepoint: Day 0 and Day 90 <br/ ><br>