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A study of Chewable Gummies for Hair-fall.

An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Chewable Gummies in healthy adult subjects with Hair fall.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044809
Enrollment
36
Registered
2022-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nyumi Happy Hair Gummies: Simply chew and swallow 2 gummies together after dinner for 90 days. Control Intervention1: NA: NA

Sponsors

Ikaria Wellness Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects having 50 to 100 hair fall per day. 2.Females with at least 50 count of hair fall and Males with 30-50 count of hair fall from hair combing method. (60-sec hair count) 3.Subjects with thin hair. 4.Male subjects with minimum hair length of 2 inches will be included.

Exclusion criteria

Exclusion criteria: 1.History of any dermatological condition of the scalp other than hair loss and/or dandruff. 2.Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study. 3.Subjects who have undergone hair growth treatment within 3 months before screening. 4.Subjects who are on chronic oral steroids 03 months before initial application and during the study period.

Design outcomes

Primary

MeasureTime frame
Anagen and telogen ratio (A:T ratio) by hair pluck test and microscopic evaluationTimepoint: baseline i.e., Day 01 and after treatment on Day 90 (plus 2 days)

Secondary

MeasureTime frame
Change in general appearance of scalp hair i.e. Hair Volume (Full â?? Medium â?? Small), Hair Density (Dense â?? Thinned/Shed) and Hair Shininess (Poor â?? Average â?? Good) by DermatologistTimepoint: baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Change in general appearance of scalp skin i.e., itchiness, redness, roughness and scaliness of scalp by DermatologistTimepoint: baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Hair Fall Reduction by counting no. of hair break after 60 second combing methodTimepoint: screening visit, baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Hair Gloss by GlossymeterTimepoint: baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Hair Strength by Hair Pull TestTimepoint: baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Hair thickness, Hair density and Hair growth by CASlite NovaTimepoint: baseline on Day 01 and after treatment on Day 50 (plus minus 2 Days) and Day 90 (plus 2 days).;Nail brittleness on the basis of Global improvement rating performed by the DermatologistTimepoint: baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Nail growth and nail health satisfaction by using 0-10 VAS scaleTimepoint: baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Product perceptionTimepoint: Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days);Subject Satisfaction QuestionnaireTimepoint: Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026