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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Capsules containing 5 mg of biotin, taken orally once daily for 12 weeks.
Kasr El Aini Hospital
Cairo, Cairo Governorate, Egypt
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, 1.5 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 7 of each assessment period
Time frame: Baseline (Week 0) and Week 12 of treatment
Patient Satisfaction with Treatment using Visual Analogue Scale (VAS)
Patient satisfaction will be measured using a 10-point visual analogue scale (VAS) where 0 = "Not satisfied at all" and 10 = "Completely satisfied". This assessment will be conducted at the end of the study (Week 12) to evaluate overall treatment satisfaction.
Time frame: Week 12 (End of Study)
Unwanted Body Hair Growth Assessment
Clinical evaluation and dermoscopy-assisted phototrichogram analysis of unwanted body hair growth in a 4 cm x 4 cm standardized area on the anterior surface of the mid-thigh. Assessment includes visual macrophotograph evaluation for hair growth and density, and dermoscopic analysis using the same dermoscopy-assisted phototrichogram (PTG) technique applied to the scalp assessment.
Time frame: Baseline (Week 0) and Week 12 of treatment
Physician Global Assessment of Hair Improvement using Standardized Macrophotographs
Assessment of overall hair improvement by two blinded dermatologists and one non-blinded dermatologist using standardized macrophotographs taken at baseline and end of therapy. Scoring will use a 5-point scale: -1 = Worsening; 0 = No improvement; 1 = Mild improvement; 2 = Moderate improvement; 3 = Excellent improvement.
Time frame: Baseline (Week 0) and Week 12 (End of Study)
Patient Global Assessment of Overall Hair Improvement
Patient self-assessment of overall hair improvement at the end of the study period using a 5-point scale: -1 = Worsening; 0 = No improvement; 1 = Mild improvement; 2 = Moderate improvement; 3 = Excellent improvement.
Time frame: Week 12 (End of Study)
Change in Dermatology Life Quality Index (DLQI) Score
Assessment of the impact of telogen effluvium on quality of life using the validated Dermatology Life Quality Index (DLQI) questionnaire. The DLQI measures the effect of skin disease on patients' quality of life across six domains. Change from baseline to end of study will be evaluated.
Time frame: Baseline (Week 0) and Week 12 (End of Study)
Safety and Tolerability of Millet Seed Extract and Biotin Forte Capsules
Clinical evaluation and monitoring for any adverse effects including gastrointestinal discomfort, allergic reactions, and unwanted body hair growth. Adverse events will be graded for severity and documented including date of onset, duration, severity, action taken, and outcome. Serious adverse events will be reported to the principal investigator and ethics committee.
Time frame: Throughout the 12-week treatment period at Baseline (Week 0), Week 6, and Week 12
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