Efficacy and Safety of Millet Seed Extract in Telogen Effluvium Treatment

NCT ID: NCT07348120

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-03-31

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.

Conditions

Telogen Effluvium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Millet Seed Extract Group

Participants in this group received Millet seed extract capsules containing 420 mg millet seed extract, 200mcg biotin, 6mg L-cystine, and 27.48 mg vitamin B5, taken orally twice daily for 12 weeks.

Group Type: EXPERIMENTAL

Millet Seed Extract group

Intervention Type: DIETARY_SUPPLEMENT

Millet seed extract capsules containing 420 mg millet seed extract, 200 mcg biotin, 6 mg L-cystine, and 27.48 mg vitamin B5, taken orally twice daily for 12 weeks. The extract is standardized to miliacin content.

Control Group

Participants in this group received capsules containing 5mg of biotin once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Biotin group

Intervention Type: DIETARY_SUPPLEMENT

Capsules containing 5 mg of biotin, taken orally once daily for 12 weeks.

Interventions

Millet Seed Extract group

Millet seed extract capsules containing 420 mg millet seed extract, 200 mcg biotin, 6 mg L-cystine, and 27.48 mg vitamin B5, taken orally twice daily for 12 weeks. The extract is standardized to miliacin content.

Intervention Type: DIETARY_SUPPLEMENT

Biotin group

Capsules containing 5 mg of biotin, taken orally once daily for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Hair shedding degree of 4 or higher according to the Hair Shedding Visual Scale (Sinclair scale).
• Diagnosis of telogen effluvium confirmed by a dermatologist after ruling out other causes of non-scarring alopecia (e.g., alopecia areata, androgenetic alopecia).
• No use of topical or systemic hair loss treatments or oral hair growth supplements for at least 1 month prior to the study.

Exclusion Criteria

• Pregnancy or breastfeeding.
• History of scalp diseases or conditions affecting hair growth like androgenic alopecia and alopecia areata.
• Use of medications known to cause hair loss.
• Any underlying medical condition that could interfere with the study.
• Use of topical treatment in the last 3 month.
• Use of systemic treatment in the last 3 month such as iron, biotin or any hair growth supplements.
• Annemia or low serum level of ferritin.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

heba ahmed abdelgayed ibrahim

Lecturer of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr El Aini Hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

MS-95-2025

Identifier Type: -

Identifier Source: org_study_id