6-Month Trial of Chinese Herbal Treatments for Hair Loss and Gray Hair

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVita Green Pharmaceutical (H.K.) Ltd.

About this trial

This will be a 6-month randomized, double-blind, placebo-controlled trial. A total of 152 participants with hair loss, including some with gray hair, will be enrolled and randomly assigned to four groups. Each group will receive a combination of oral capsules and hair tonic, to be used as directed for 24 weeks. Participants will attend three in-person visits, during which assessments-including hair-related tests and photographs-will be conducted to evaluate hair count and density. Additionally, 10 participants with gray hair from each group will undergo extra assessments focused on changes in hair color. All relevant clinical data will be systematically collected and recorded for statistical analysis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must sign the informed consent form prior to enrollment and fully understand the study's purpose, procedures, and potential adverse events.

Adults aged 18 to 60 years, both male and female; each group must include no less than 50% female participants.

Hair length must be greater than 5 cm.

Women must meet the Savin scale classification between grades 1-3 to II.

Disqualifiers

Pregnant or breastfeeding women, or individuals planning to conceive in the near future.

Individuals with medical conditions causing hair loss, such as refractory alopecia areata, inflammatory scarring alopecia, or psoriatic alopecia; or those diagnosed with other scalp or hair disorders.

Individuals with diagnosed psychiatric or psychological disorders, or those with long-term sleep disturbances or emotional regulation issues.

Use of anti-hair loss cosmetics or other hair growth-promoting products within the past 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VitaGreen Capsule A+VitaGreen Tonic

    Other intervention

    VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks

  • VitaGreen Capsule B+VitaGreen Tonic

    Other intervention

    VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks

  • Capsule Placebo+VitaGreen Tonic

    Other intervention

    Capsule Placebo+VitaGreen Tonic,use 24 weeks

  • Capsule Placebo+Tonic Placebo

    Other intervention

    Capsule Placebo+Tonic Placebo,use 24 weeks

Treatment groups

152 Participants
are divided into 4 treatment groups
Group A: VitaGreen Capsule A+VitaGreen TonicExperimental treatment 1 intervention
Group B: VitaGreen Capsule B+VitaGreen TonicExperimental treatment 1 intervention
Group C: Capsule Placebo+VitaGreen TonicExperimental treatment 1 intervention
Group D: Capsule Placebo+Tonic PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hair Shedding Count

Combing the hair 60 times and recording the number of hairs that fall out during the process

Time frame
Baseline, week 12, week 24
2

Local Hair Count

Detected by Dermatoscope

Time frame
Baseline, week 12, week 24
3

Local Hair Density

Detected by Dermatoscope

Time frame
Baseline, week 12, week 24
4

percentage of Vellus Hair

Detected by Dermatoscope

Time frame
Baseline, week 12, week 24

Secondary outcomes

1

local hair color scores and white hair Index

Doctor evaluates local hair color scles according to Wig Color Grading(Value1 to Value 6)and calculates the white hair Index

Time frame
Baseline, week 12, week 24
2

Complete Blood Count concentrations

Blood sample detected by Hematology Analyzer

Time frame
Baseline, week 24
3

Urinalysis concentrations

Urine sample detected by Urine Analyzer

Time frame
Baseline, week 24
4

Aspartate Aminotransferase concentrations

Blood sample detected by Biochemical analyzer

Time frame
Baseline, week 24

Other outcomes

Sponsors and contacts

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