A cluster randomized controlled trial of Uyghur medicine combined with glucocorticoid in the treatment of advanced Vitiligo

Not Applicable

• Conditions: Vitiligo

• Registration Number: ITMCTR2023000029
• Lead Sponsor: Hospital of Xinjiang Traditional Uyghur Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients diagnosed as vitiligo in advanced stage, and with VIDA score>1 point.
2) Patients whose severity rating is Grade 1 (mild, unlimited in special parts, and = 0.09% in other parts (3 knuckles)); Level 2 (moderate, with a white spot area of 1% -5% of the body surface area); Level 3 (moderate to severe, with a white spot area of 6% -50%); Patients with grade 4 (severe, with a white spot area greater than 50%).
3) Vitiligo patients diagnosed as non-segmental (ordinary) Vitiligo, including sporadic, generalized and mixed vitiligo.
4) Vitiligo patients with astringent myxoid syndrome in Uyghur medicine.
5) aged 18-65
6) with imformed consent.

Exclusion Criteria

1) Patients with Vitiligo of external genitalia, anus and mucous membrane in special parts.
2) Some skin rashes have left behind Depigmentation, anemic nevus, albinism, and other syndromes that cause leukoplakia, senile leukoplakia, amelanotic nevus, and solar leukoplakia.
3) Patients with active tuberculosis, malignant tumor progression, or a history of tumor within 5 years.
4) Combined with severe cardiac insufficiency, severe primary diseases such as liver and kidney systems. (Note: ALT and AST exceed the upper limit of the normal range by 2 times, while Cr exceeds the upper limit of the normal range.)
5) I have taken steroids and any kind of medicine for Vitiligo in recent 2 weeks; And/or took retinoic acid drugs or steroid preparations for external use and any Topical medication for the treatment of Vitiligo within one week.
6) Plan for pregnant, pregnant, or lactating women.
7) Suspected or confirmed history of alcohol or drug abuse.
8) Allergic constitution (to 2 or more other drugs), or allergic to the drug components in this diagnosis and treatment plan.
9) Other situations that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, mental disorders, communication difficulties, etc., are deemed unsuitable by researchers to participate in this clinical trial.
10) participated in clinical trials of other drugs or are currently participating in other clinical trials within the past month.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitiligo area score index (VASI) score decline index;

Secondary Outcome Measures

Name	Time	Method
yghur Medical Syndrome Score;Post effect of 24 weeks;Stable condition in week 12;Dermatology Life Quality Index, DLQI;