Telogen EffluviumNCT07348120
Efficacy and Safety of Millet Seed Extract in Telogen Effluvium Treatment
A study testing Millet Seed Extract group and Biotin group in people with Telogen Effluvium, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Telogen Effluvium
- What is being tested?
- Millet Seed Extract group and Biotin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Millet Seed Extract in the Treatment of Telogen Effluvium in Female Patients: A Randomized, Double-Blind, Controlled Trial
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.
Read the 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
- Being tested
- Millet Seed Extract group, Biotin group
- Keywords
- hair loss, millet seed extract, hair growth, biotin, telogen effluvium
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Millet Seed Extract groupDietary 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.
Biotin groupDietary supplement
Capsules containing 5 mg of biotin, taken orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Biotin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Week 0) and Week 12 of treatment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the 12-week treatment period at Baseline (Week 0), Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 May 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telogen EffluviumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed abdelgayed ibrahim, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348120
- Sponsor's protocol ID
- MS-95-2025
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Millet Seed Extract in the Treatment of Telogen Effluvium in Female Patients: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07348120
- Acronym / sponsor ID
- MS-95-2025
- Conditions
- Telogen Effluvium
- Keywords
- hair loss, millet seed extract, hair growth, biotin, telogen effluvium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Millet Seed Extract Group | Experimental | Dietary Supplement: Millet Seed Extract groupParticipants 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. |
| Control Group | Active comparator | Dietary Supplement: Biotin groupParticipants in this group received capsules containing 5mg of biotin once daily for 12 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Millet Seed Extract groupMillet 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. | Dietary supplement | Millet Seed Extract Group |
| Biotin groupCapsules containing 5 mg of biotin, taken orally once daily for 12 weeks. | Dietary supplement | Control Group |
Primary outcome
Change in Telogen and Anagen Hair Densities measured by Dermoscopy-Assisted Phototrichogram
Time frame: Baseline (Week 0) and Week 12 of treatment
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
6 secondary outcomes
Patient Satisfaction with Treatment using Visual Analogue Scale (VAS)
Time frame: Week 12 (End of Study)
Unwanted Body Hair Growth Assessment
Time frame: Baseline (Week 0) and Week 12 of treatment
Physician Global Assessment of Hair Improvement using Standardized Macrophotographs
Time frame: Baseline (Week 0) and Week 12 (End of Study)
Patient Global Assessment of Overall Hair Improvement
Time frame: Week 12 (End of Study)
Change in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline (Week 0) and Week 12 (End of Study)
Safety and Tolerability of Millet Seed Extract and Biotin Forte Capsules
Time frame: Throughout the 12-week treatment period at Baseline (Week 0), Week 6, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Millet Seed Extract group and Biotin group in people with Telogen Effluvium, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Telogen and Anagen Hair Densities measured by Dermoscopy-Assisted Phototrichogram (time frame: Baseline (Week 0) and Week 12 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.