AlopeciaNCT06998680
6-Month Trial of Chinese Herbal Treatments for Hair Loss and Gray Hair
A study testing VitaGreen Capsule A+VitaGreen Tonic and VitaGreen Capsule B+VitaGreen Tonic in people with Alopecia and Canities, run by Vita Green Pharmaceutical (H.K.) Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- VitaGreen Capsule A+VitaGreen Tonic and VitaGreen Capsule B+VitaGreen Tonic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Xiangtan City
Xiangtan, Hunan, 411100
Longke Tan, 86-13907329755, 328636581@qq.com
About this study
Official 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
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.
- Being tested
- VitaGreen Capsule A+VitaGreen Tonic, VitaGreen Capsule B+VitaGreen Tonic, Capsule Placebo+VitaGreen Tonic, Capsule Placebo+Tonic Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaGreen Capsule A+VitaGreen TonicOther
VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks
VitaGreen Capsule B+VitaGreen TonicOther
VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks
Capsule Placebo+VitaGreen TonicOther
Capsule Placebo+VitaGreen Tonic,use 24 weeks
Capsule Placebo+Tonic PlaceboOther
Capsule Placebo+Tonic Placebo,use 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| VitaGreen Capsule A+VitaGreen Tonic | Experimental | Not described Receives: Other: VitaGreen Capsule A+VitaGreen Tonic |
| VitaGreen Capsule B+VitaGreen Tonic | Experimental | Not described Receives: Other: VitaGreen Capsule B+VitaGreen Tonic |
| Capsule Placebo+VitaGreen Tonic | Experimental | Not described Receives: Other: Capsule Placebo+VitaGreen Tonic |
| Capsule Placebo+Tonic Placebo | Placebo comparator | Not described Receives: Other: Capsule Placebo+Tonic Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Shedding Count
Combing the hair 60 times and recording the number of hairs that fall out during the process
Measured: Baseline, week 12, week 24
Local Hair Count
Detected by Dermatoscope
Measured: Baseline, week 12, week 24
Local Hair Density
Detected by Dermatoscope
Measured: Baseline, week 12, week 24
percentage of Vellus Hair
Detected by Dermatoscope
Measured: Baseline, week 12, week 24
Percentage of Terminal Hair
Detected by Dermatoscope
Measured: 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
Measured: Baseline, week 12, week 24
Secondary outcomes (9)
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
Measured: Baseline, week 12, week 24
Complete Blood Count concentrations
Blood sample detected by Hematology Analyzer
Measured: Baseline, week 24
Urinalysis concentrations
Urine sample detected by Urine Analyzer
Measured: Baseline, week 24
Aspartate Aminotransferase concentrations
Blood sample detected by Biochemical analyzer
Measured: Baseline, week 24
Alanine Aminotransferase concentrations
Blood sample detected by Biochemical analyzer
Measured: Baseline, week 24
Creatinine concentrations
Blood sample detected by Biochemical Analyzer
Measured: Baseline, week 24
Urea Nitrogen concentrations
Blood sample detected by Biochemical Analyzer
Measured: Baseline, week 24
Serum Uric Acid concentrations
Blood sample detected by Biochemical Analyzer
Measured: Baseline, week 24
Adverse Events
counting and documenting adverse events happening during the experiment
Measured: Baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start30 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies 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, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vita Green Pharmaceutical (H.K.) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998680
- Sponsor's protocol ID
- 2025011301
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06998680
- Acronym / sponsor ID
- 2025011301
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Vita Green Pharmaceutical (H.K.) Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 31 May 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| VitaGreen Capsule A+VitaGreen TonicVitaGreen Capsule A+VitaGreen Tonic,use 24 weeks | Other | VitaGreen Capsule A+VitaGreen Tonic |
| VitaGreen Capsule B+VitaGreen TonicVitaGreen Capsule B+VitaGreen Tonic,use 24 weeks | Other | VitaGreen Capsule B+VitaGreen Tonic |
| Capsule Placebo+VitaGreen TonicCapsule Placebo+VitaGreen Tonic,use 24 weeks | Other | Capsule Placebo+VitaGreen Tonic |
| Capsule Placebo+Tonic PlaceboCapsule Placebo+Tonic Placebo,use 24 weeks | Other | Capsule Placebo+Tonic Placebo |
Primary outcome
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
Local Hair Count
Time frame: Baseline, week 12, week 24
Detected by Dermatoscope
Local Hair Density
Time frame: Baseline, week 12, week 24
Detected by Dermatoscope
percentage of Vellus Hair
Time frame: Baseline, week 12, week 24
Detected by Dermatoscope
Percentage of Terminal Hair
Time frame: Baseline, week 12, week 24
Detected by Dermatoscope
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
9 secondary outcomes
local hair color scores and white hair Index
Time frame: Baseline, week 12, week 24
Complete Blood Count concentrations
Time frame: Baseline, week 24
Urinalysis concentrations
Time frame: Baseline, week 24
Aspartate Aminotransferase concentrations
Time frame: Baseline, week 24
Alanine Aminotransferase concentrations
Time frame: Baseline, week 24
Creatinine concentrations
Time frame: Baseline, week 24
Urea Nitrogen concentrations
Time frame: Baseline, week 24
Serum Uric Acid concentrations
Time frame: Baseline, week 24
Adverse Events
Time frame: Baseline, week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaGreen Capsule A+VitaGreen Tonic and VitaGreen Capsule B+VitaGreen Tonic in people with Alopecia and Canities, run by Vita Green Pharmaceutical (H.K.) Ltd. at 1 site in China.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naya Chen (86-021-31073699, chenyinghuixuan@cti-cert.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Shedding Count (time frame: Baseline, week 12, week 24). The study lists 6 primary outcomes in all. 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 19 Sep 2025.