Hair growth after using Herbodaya hair oil

Phase 3

Completed

• Conditions: Other androgenic alopecia,

• Registration Number: CTRI/2018/12/016730
• Lead Sponsor: SKM SIDDHA AND AYURVEDA COMPANY INDIA Pvt Ltd

Brief Summary

The subjects who fulfilled the inclusion and exclusion criteria willbe enrolled in the study

The selected subjects should be randomized for test and controltherapy.

The Test arm 1 will receiveHerbodaya Bringa Hair oil & Shikaka Hair Wash. The subjects will be asked to take 5-10ml of the hair oiland gently apply & massage the oil daily for a period of 12 weeks. Theywill be asked to apply the oil from the ends towards the roots of the hairfollicles, hair root, scalp and to the length of the hair. The oil will beallowed to work on the scalp overnight. Herbodaya Shikaka hair wash will beused to wash the hair twice a week for 12 weeks.

The Reference arm 2 will receive Indulekha bringha hair oil. Thesubjects will be asked to take 5-10ml and gently apply & massage the oildaily for a period of 12 weeks.

The Reference arm 3 will receive Dhatri hairoil. The subjects will be asked to take 5-10ml and gently apply & massagethe oil daily for a period of 12 weeks.

The primary and secondary outcome will be analyzed on 4th, 8th and 12th week.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-31
• Study Completion: 2019-03-21
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subjects with hair loss disorders such as telogen effluvium (as first line therapy), chronic female pattern hair loss, Androgenetic Alopecia (Stage I – IV) 2.
• Subjects who are willing to give written informed consent.

Exclusion Criteria

• 1.Androgenetic alopecia (Stage V and beyond) 2.Evidence of dermatological disease as revealed by history, physical examination or laboratory assessment which may interfere with administration or assessment of study medication 3.Current use of dermatological drugs / preparations which may interfere with study evaluation.
• 4.Intolerance to any of ingredients of the formulation 5.Current alcohol or drug abuse 6.Subjects viewed by the investigator as not being able to complete the study.
• 7.Use of Hair product such as hair dyes, sprays, setting gels and restorers 8.Any procedures for hair enhancement and curling or straightening technique 9.Pregnant or breastfeeding women 10.
• Having abnormal thyroid profile.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in global photographic assessment for hair growth.	AT 4 weeks, 8 weeks and 12 weeks.
2. VAS- Visual analog scale.	AT 4 weeks, 8 weeks and 12 weeks.
3. Change in the investigator assessment score for Hair count in each	AT 4 weeks, 8 weeks and 12 weeks.
visit from enrollment onwards after treating with IP.	AT 4 weeks, 8 weeks and 12 weeks.
4. Subjective Assessment by the subjects using diary card	AT 4 weeks, 8 weeks and 12 weeks.
Evaluation technique.	AT 4 weeks, 8 weeks and 12 weeks.
5. Percentage of subjects responding to the therapy.	AT 4 weeks, 8 weeks and 12 weeks.
6. Acceptability of the treatment.	AT 4 weeks, 8 weeks and 12 weeks.
7. Global assessment for efficacy by Investigator and subjects.	AT 4 weeks, 8 weeks and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events measured	4,8 and 12 weeks

Trial Locations

Locations (1)

Madras Medical College, Chennai; 🇮🇳 Vellore, TAMIL NADU, India

Madras Medical College, Chennai

🇮🇳Vellore, TAMIL NADU, India

Dr Ramesh Kannan

Principal investigator

7708925866

srkguruvarshan@gmail.com