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

Официальное название

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

Обзор

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.

Вмешательства

• Другое VitaGreen Capsule A+VitaGreen Tonic
  VitaGreen Capsule A+VitaGreen Tonic,use 24 weeks
• Другое VitaGreen Capsule B+VitaGreen Tonic
  VitaGreen Capsule B+VitaGreen Tonic,use 24 weeks
• Другое Capsule Placebo+VitaGreen Tonic
  Capsule Placebo+VitaGreen Tonic,use 24 weeks
• Другое Capsule Placebo+Tonic Placebo
  Capsule Placebo+Tonic Placebo,use 24 weeks

Первичные конечные точки

• Hair Shedding Count [Срок оценки: Baseline, week 12, week 24]
• Local Hair Count [Срок оценки: Baseline, week 12, week 24]
• Local Hair Density [Срок оценки: Baseline, week 12, week 24]
• percentage of Vellus Hair [Срок оценки: Baseline, week 12, week 24]
• Percentage of Terminal Hair [Срок оценки: Baseline, week 12, week 24]
• Scoring of Hair Changes from Images [Срок оценки: Baseline, week 12, week 24]

Вторичные конечные точки (9)

• local hair color scores and white hair Index [Срок оценки: Baseline, week 12, week 24]
• Complete Blood Count concentrations [Срок оценки: Baseline, week 24]
• Urinalysis concentrations [Срок оценки: Baseline, week 24]
• Aspartate Aminotransferase concentrations [Срок оценки: Baseline, week 24]
• Alanine Aminotransferase concentrations [Срок оценки: Baseline, week 24]
• Creatinine concentrations [Срок оценки: Baseline, week 24]
• Urea Nitrogen concentrations [Срок оценки: Baseline, week 24]
• Serum Uric Acid concentrations [Срок оценки: Baseline, week 24]
• Adverse Events [Срок оценки: Baseline, week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First People's Hospital of Xiangtan City — Xiangtan

Идентификаторы

NCT: NCT06998680 · 2025011301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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