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NCT Number: NCT06998680

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First People's Hospital of Xiangtan City

Xiangtan, Hunan, 411100, China

Location status: Recruiting

Location contact

Longke Tan

CONTACT

[email protected]

86-13907329755

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Men must meet the Norwood-Hamilton classification between stages II and VI.
  • At least 10 participants in each group must have gray hair, with a minimum of 5 gray hairs within a 1 cm × 4 cm area of the scalp.
  • Participants must not have undergone any special hair treatments-such as dyeing, perming, or styling-within the past two months.

Exclusion criteria

  • 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.
  • Use of any systemic or topical medications known to affect hair growth within the past 6 months.
  • History of hair transplantation.
  • Curly hair.
  • Individuals with highly sensitive constitutions.
  • Individuals diagnosed with severe anemia or abnormal liver/kidney function during physical examination.
  • Participation in any other clinical trials involving the test area within the past 2 months.
  • Any other conditions deemed unsuitable for participation by the clinical investigators.

Treatment and study plan

VitaGreen Capsule A+VitaGreen Tonic

Other

VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks

VitaGreen Capsule B+VitaGreen Tonic

Other

VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks

Capsule Placebo+VitaGreen Tonic

Other

Capsule Placebo+VitaGreen Tonic,use 24 weeks

Capsule Placebo+Tonic Placebo

Other

Capsule Placebo+Tonic Placebo,use 24 weeks

Primary outcomes

  1. Hair Shedding Count

    Time frame: Baseline, week 12, week 24

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

  2. Local Hair Count

    Time frame: Baseline, week 12, week 24

    Detected by Dermatoscope

  3. Local Hair Density

    Time frame: Baseline, week 12, week 24

    Detected by Dermatoscope

  4. percentage of Vellus Hair

    Time frame: Baseline, week 12, week 24

    Detected by Dermatoscope

  5. Percentage of Terminal Hair

    Time frame: Baseline, week 12, week 24

    Detected by Dermatoscope

  6. Scoring of Hair Changes from Images

    Time frame: Baseline, week 12, week 24

    Doctor scores hair changes from Images pictured by camera with scale of 0 to 4

Secondary outcomes

  1. local hair color scores and white hair Index

    Time frame: Baseline, week 12, week 24

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

  2. Complete Blood Count concentrations

    Time frame: Baseline, week 24

    Blood sample detected by Hematology Analyzer

  3. Urinalysis concentrations

    Time frame: Baseline, week 24

    Urine sample detected by Urine Analyzer

  4. Aspartate Aminotransferase concentrations

    Time frame: Baseline, week 24

    Blood sample detected by Biochemical analyzer

  5. Alanine Aminotransferase concentrations

    Time frame: Baseline, week 24

    Blood sample detected by Biochemical analyzer

  6. Creatinine concentrations

    Time frame: Baseline, week 24

    Blood sample detected by Biochemical Analyzer

  7. Urea Nitrogen concentrations

    Time frame: Baseline, week 24

    Blood sample detected by Biochemical Analyzer

  8. Serum Uric Acid concentrations

    Time frame: Baseline, week 24

    Blood sample detected by Biochemical Analyzer

  9. Adverse Events

    Time frame: Baseline, week 24

    counting and documenting adverse events happening during the experiment

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Vita Green Pharmaceutical (H.K.) Ltd.

Industry

Registry information

Official study title

A 6-Month Randomized Double-Blind Placebo-Controlled Trial Assessing the Efficacy of Oral and Topical Traditional Chinese Medicine Products on Alopecia and Canities

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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