Efficacy and Safety of Millet Seed Extract in Telogen Effluvium Treatment

NCT07348120 | Completed

• 1 other identifier: MS-95-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Telogen Effluvium

Keywords

hair loss; millet seed extract; hair growth; biotin; telogen effluvium

Outcome Measures

Primary Outcomes (1)

• Change in Telogen and Anagen Hair Densities measured by Dermoscopy-Assisted Phototrichogram

  Percentage change in telogen and anagen hair densities in the specified scalp area (external occipital protuberance region, 1 cm²) from baseline to week 12. Telogen and anagen densities will be calculated as the number of telogen/anagen hairs divided by total hair count in the selected area multiplied by 100. Measurements will be performed using dermoscopy-assisted phototrichogram (PTG) analysis with microphotographs taken on day 0 and day 3 of each assessment period

  Baseline (Week 0) and Week 12 of treatment

Secondary Outcomes (6)

• Patient Satisfaction with Treatment using Visual Analogue Scale (VAS)

  Week 12 (End of Study)

• Unwanted Body Hair Growth Assessment

  Baseline (Week 0) and Week 12 of treatment

• Physician Global Assessment of Hair Improvement using Standardized Macrophotographs

  Baseline (Week 0) and Week 12 (End of Study)

• Patient Global Assessment of Overall Hair Improvement

  Week 12 (End of Study)

• Change in Dermatology Life Quality Index (DLQI) Score

  Baseline (Week 0) and Week 12 (End of Study)

Study Arms (2)

Millet Seed Extract Group

EXPERIMENTAL

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.

Dietary Supplement: Millet Seed Extract group

Control Group

ACTIVE COMPARATOR

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

Dietary Supplement: Biotin group

Interventions

Millet Seed Extract group 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.

Millet Seed Extract Group

Biotin group DIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, Cairo Governorate, 11555, Egypt

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)