Clinical study on Guben Tongluo Formula in the treatment of Vitiligo caused by Meridian stasis

Phase 1

• Conditions: Vitiligo

• Registration Number: ITMCTR2200005657
• Lead Sponsor: Dermatology Hospital of Southern Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.TCM diagnosis is consistent with meridian stasis type with liver and kidney deficiency type of vitiligo: the main manifestations are skin leukoplakia for a long time, porcelain white or milky white, clear boundaries, or accompanied by dark complexion, blue and purple lips, dark purple tongue or ecchymosis, astringent pulse, or insomnia, dizziness, sore waist and knees. Red tongue, less fur, fine pulse or sunken number, etc.
2.Western medicine diagnosed as non-segmental vitiligo, including: sporadic, generalized, face and neck type, limb type and mucous type.
3.the age is 18-65 years old, the sex is not limited, the course of disease is = 5 years; 4. the affected area of vitiligo must conform to the following two points at the same time:-there must be facial involvement, facial involved area = 0.1% body surface area (BSA)-whole body involved area = 20% (BSA) Note: when calculating the whole body involved area, including the face and neck, excluding hands, feet, mucous membranes and genitals.
5. voluntarily sign informed consent, be willing and follow the research procedures such as visit and treatment plan, laboratory examination and cooperation before and after treatment

Exclusion Criteria

1.Those who resist or cannot insist on oral traditional Chinese medicine;
2.Those who are allergic to the ingredients of tacrocarnitol ointment;
3.Subjects with segmental, mixed and unclassified vitiligo;
4.Those with any blood routine and abnormal liver and renal function during the screening period;
-Hemoglobin level < 9.0g / DL; or hematocrit < 30%; or absolute white blood cell count < 3.0 × 109 / L; or absolute neutrophil count (ANC) < 1.2 × 109 ml. Or platelet count < 100 × 109 / L
-subjects with impaired liver function (such as total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the normal limit).
-Renal dysfunction (Scr male > 132umol/L, female > 106umol/L)
5.subjects who had received any other treatment during the period prior to the baseline:
-received any laser or optical therapy for vitiligo (including tanning beds) within 4 weeks before the baseline.
-to receive oral or systemic drugs (e.g., glucocorticoid, cyclosporine, methotrexate, tacrolimus, etc.) designed to control / improve the symptoms of vitiligo within 4 weeks before the baseline;
-topical therapy to control / improve the symptoms of vitiligo within 2 weeks before the baseline (e.g., glucocorticoid, tacrolimus, pimecrolimus, capotriol, etc.);-skin discoloration therapy has been received.
6.There is any one complicated with serious diseases, such as severe heart, brain, liver,kidney,hematopoietic system diseases, or patients with malignant tumors;
-subjects who are positive in laboratory tests for human immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or syphilis;
-Have a malignant tumor or have a history of malignant tumors (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin after adequate treatment or resection).
-Diseases that have previously existed or currently have clinical significance or abnormal test results or require the use of drugs that are not allowed in the regimen. meaningful is defined as the fact that the researchers believe that participation in the study will pose a risk to the safety of the subjects or affect the efficacy or safety analysis when the disease / illness worsens during the study period;
7.With a history of mental illness or disease such as anxiety or depression, it is not appropriate for the researchers to participate in this study;
8.female patients who are pregnant, breastfeeding or planning to become pregnant within half a year.
9.local skin lesions are red, swollen, damaged or infected;-during baseline visits, they suffer from other active skin lesions (psoriasis, dermatitis, skin rupture, etc.) or skin infections (bacteria, fungi, viruses, etc.) that may interfere with the use of research drugs or the evaluation of the efficacy of research drugs.
-two or more previous episodes of herpes zoster, a history of disseminated herpes zoster or a history of infection that other researchers believe may be aggravated by participation in the study;
-there is a major clinical infection within 1 month before the screening visit (need to be hospitalized and treated with antibiotics, antivirals, antifungal drugs, etc.) or active infections that are being treated during the screening period.
-had active TB, was receiving anti-TB treatment or received anti-TB treatment within 1 year before receiving the first study drug;
10.subjects whose other conditions were not appropriate;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Facial leukoplakia area;

Secondary Outcome Measures

Name	Time	Method
Scoring form of TCM symptoms;Overall leukoplakia area;