Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:59 PM
Study NCT ID:
NCT07348120
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Millet Seed Extract in Telogen Effluvium Treatment
Sponsor:
Kasr El Aini Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Millet Seed Extract in the Treatment of Telogen Effluvium in Female Patients: A Randomized, Double-Blind, Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, double-blind, controlled clinical trial investigating the efficacy and safety of millet seed extract capsules in treating telogen effluvium in female patients. The study will recruit 60 female participants with telogen effluvium who will be randomly assigned to receive either millet seed extract capsules (containing 420 mg millet seed extract, 200 mcg biotin, 6 mg L-cystine, and 27.48 mg vitamin B5) twice daily or Biotin forte capsules (5 mg biotin) once daily for 12 weeks. The primary outcome will measure changes in telogen and anagen hair densities using dermoscopy-assisted phototrichography. Secondary outcomes will assess patient satisfaction and unwanted body hair growth. Safety will be monitored throughout the study period at Cairo University's dermatology clinic.
Detailed Description:
Telogen effluvium is characterized by diffuse hair shedding that significantly impacts quality of life. Millet seed extract, rich in bioactive compounds including miliacin, offers a promising natural treatment approach. This 12-week randomized, double-blind, controlled trial will recruit 60 female patients with telogen effluvium at Kasr Al Ainy, Cairo University. Participants will be randomly assigned to receive either millet seed extract capsules (420 mg millet seed extract, 200 mcg biotin, 6 mg L-cystine, 27.48 mg vitamin B5 twice daily) or biotin forte capsules (5 mg once daily). Primary outcome measures include telogen and anagen hair densities assessed by dermoscopy-assisted phototrichography at baseline and week 12. Secondary outcomes include patient satisfaction, unwanted body hair growth assessment, and Dermatology Life Quality Index scores. Safety will be monitored throughout the study period with adverse event reporting. The study includes female patients aged 18+ with clinically and trichoscopically confirmed telogen effluvium and hair shedding degree of 4 or higher on the Sinclair scale, excluding those with pregnancy, scalp diseases, or medication-induced hair loss.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: