To study the Safety and Efficacy of Investigational Hair oil in comparison with coconut oil and comparator Hair oil in subjects with mild to severe Hair fall
- Conditions
- HairfallAlopecia areata,
- Registration Number
- CTRI/2020/04/024824
- Lead Sponsor
- Thai Herbals
- Brief Summary
At screening on day 1 (Visit 1), Volunteers after giving written informed consent, will be given screening numbers and subjected to screening procedures. Eligible volunteers will be enrolled in the study and Medical History along with physical examination and demography will be collected.
All selected 40 subjects will be provided with Investigational Hair Oil or Coconut oil or Comparator Hair Oil in 2:1:1 ratio (as per randomization chart). In each arm, the subjects will be instructed to use the oil (quantity depending upon the length of hair) daily after hair wash.
Subjects will be asked to massage the scalp and comb hair, shake the bottle well to evenly distribute the medicinal content. They will be instructed to do the following:
1. Take 5ml of oil on palm and rub together, apply the oil onto scalp and from root to tip of hair.
2. Massage well for 3-5 minutes and leave on. Use a mild shampoo once in every 3 days to wash hair.
3. On other days wash hair with water alone if required
The subjects will be advised to stop the usage of any routine hair oil or any other hair care products for the entire study duration and use only the provided IP during these 6 weeks of study duration.
Assessment of the hair fall reduction, hair growth stimulation (both existing hair growth and new hair growth), hair damage protection, shine and health of hair , Cooling effect and dandruff control will be done by investigator during all the follow up visits in primary assessment sheet. (PAS). Adverse event recording will be done during all the visits.
Hair Test to analyze the tensile strength, porosity and cuticle alignment of hair strands, tug test, float test and slide test will be performed during each visit.
Assessment of visible hair fall reduction, hair growth in length and thickness, reduction in breakages and split ends, improvements in hair strength (elasticity), hair shine, smoothness, texture and appearance, scalp itching, scaling, product lightness and non-stickiness will be filled during final visit in subject assessment sheet (SAS) by subjects.
Assessment of visible hair fall reduction, hair growth in length and thickness, reduction in breakages and split ends, improvements in hair strength (elasticity), hair shine, smoothness, texture and appearance, scalp itching and scaling will be assessed during final visit in investigator assessment sheet (IAS) by investigator.
Subject’s feedback on product smell, smell of hair after applying the product, existence of smell on the hair will be done using subject feedback sheet during final visit by subject.
On the follow up visits (Day 7, Day 10, Day 15, Day 21, Day 28 and Day 42), the subjects will be asked to inform the investigator in case they take any medication for any condition during the study term/Period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- 1.Willingness to give written informed consent 2.Subjects with mild to severe hair fall.
- (Severe -50 percent, moderate-30 percent,mild- 20 percent) 3.Subjects with no skin allergies to any cosmetic products 4.Willingness to discontinue any hair care product other than the IP throughout the study.
- 5.Subjects who is not willing to color their hair throughout the treatment period 6.Subjects willing to discontinue all the hair care treatments such as hair spa,straightening, curling, hair perming, etc.
- throughout the treatment period 7.Willingness to follow the protocol requirements as evidenced by written informed consent 8.Comprehension of the nature and purpose of the study and compliance with the requirement of the entire procedure 9.In addition, female subjects selected for the study must be able to use a medically acceptable form of birth control during the study or be surgically sterile or be post menopausal for at least 1 year.
- 1.Subjects with known hypersensitivity to any specific ingredients of IP’s 2.Subjects below the age of 18 years and subjects above 50 years 3.Subjects not willing to participate in the study 4.Subjects who have previously undergone hair transplantation procedures 5.Subjects with other skin diseases.
- 6.Subjects are being treated for hair fall or severe active infection of any type.
- 7.Presence of any underlying significant uncontrolled medical illness involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic,immunologic, hematological, endocrine, or nervous systems or psychiatric disease, HIV.
- 8.Subjects with pre-existing scalp disorder such as scalp psoriasis, lichen planus,lichen planopilaris, DLE-Discoid lupus erythematosus, sebopsoriasis will be excluded from the study.
- 9.A female subject who is breast-feeding, pregnant or intends to become pregnant during the study.
- 10.Participating in a clinical research trial within 30 days prior to screening.
- 11.Subjects who are cognitively impaired and/or who are unable to give informed consent 12.Any other health or mental condition that in the Investigator’s opinion may adversely affect the ability to complete the study or its measures or that may pose significant risk to the subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Hair fall Reduction Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 2.Hair growth stimulation Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 3.Growth of existing hair Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 4.New hair growth Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 5.Hair damage protection Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 6.Shine and health of hair Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 7.Cooling effect Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42 8.Dandruff control Visit1 day1 | Visit2 day7 | Viist3 day10 | Visit4 day15 | Visit5 day21 | Visit6 day28 | Visit7 day42
- Secondary Outcome Measures
Name Time Method 1.Visible hair fall reduction 2.Hair growth improvement -length and thickness
Trial Locations
- Locations (1)
Singhvi Health center
🇮🇳Chennai, TAMIL NADU, India
Singhvi Health center🇮🇳Chennai, TAMIL NADU, IndiaDr Radha K RPrincipal investigator9176049309drradhakr770@gmail.com