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

NCT06998680 | Recruiting

• 1 other identifier: 2025011301
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alopecia; Canities

Outcome Measures

Primary Outcomes (6)

• Hair Shedding Count

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

  Baseline, week 12, week 24

• Local Hair Count

  Detected by Dermatoscope

  Baseline, week 12, week 24

• Local Hair Density

  Detected by Dermatoscope

  Baseline, week 12, week 24

• percentage of Vellus Hair

  Detected by Dermatoscope

  Baseline, week 12, week 24

• Percentage of Terminal Hair

  Detected by Dermatoscope

  Baseline, week 12, week 24

• Scoring of Hair Changes from Images

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

  Baseline, week 12, week 24

Secondary Outcomes (9)

• local hair color scores and white hair Index

  Baseline, week 12, week 24

• Complete Blood Count concentrations

  Baseline, week 24

• Urinalysis concentrations

  Baseline, week 24

• Aspartate Aminotransferase concentrations

  Baseline, week 24

• Alanine Aminotransferase concentrations

  Baseline, week 24

Study Arms (4)

VitaGreen Capsule A+VitaGreen Tonic

EXPERIMENTAL

Other: VitaGreen Capsule A+VitaGreen Tonic

VitaGreen Capsule B+VitaGreen Tonic

EXPERIMENTAL

Other: VitaGreen Capsule B+VitaGreen Tonic

Capsule Placebo+VitaGreen Tonic

EXPERIMENTAL

Other: Capsule Placebo+VitaGreen Tonic

Capsule Placebo+Tonic Placebo

PLACEBO COMPARATOR

Other: Capsule Placebo+Tonic Placebo

Interventions

VitaGreen Capsule A+VitaGreen Tonic OTHER

VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks

VitaGreen Capsule A+VitaGreen Tonic

VitaGreen Capsule B+VitaGreen Tonic OTHER

VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks

VitaGreen Capsule B+VitaGreen Tonic

Capsule Placebo+VitaGreen Tonic OTHER

Capsule Placebo+VitaGreen Tonic,use 24 weeks

Capsule Placebo+VitaGreen Tonic

Capsule Placebo+Tonic Placebo OTHER

Capsule Placebo+Tonic Placebo,use 24 weeks

Capsule Placebo+Tonic Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vita Green Pharmaceutical (H.K.) Ltd.: lead

Study Sites (1)

The First People's Hospital of Xiangtan City

Xiangtan, Hunan, 411100, China

RECRUITING

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

Central Study Contacts

Naya Chen

CONTACT

86-021-31073699; chenyinghuixuan@cti-cert.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 31, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)