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研究疾病：
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白癜风
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研究疾病代码：
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Target disease：
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Vitiligo
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Target disease code：
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研究类型：
Study type：
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干预性研究
Interventional study
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研究设计：
Study design：
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段：
Study phase：
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探索性研究/预试验
Pilot clinical trial
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研究目的：
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确定固本通络方治疗经络瘀阻型白癜风的临床疗效
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Objectives of Study：
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Clinical study on Guben Tongluo Formula in the treatment of Vitiligo caused by Meridian stasis
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药物成份或治疗方案详述：
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治疗组：选择固本通络方
中药配方颗粒：
旱莲草8g 白芷8g 何首乌 5g，
沙蒺藜8g 刺蒺藜8g 紫草 5g，
紫丹参8g 苍术8g 赤芍8g
川芎8g 桃仁8g 红花8g
日1剂，分两次服用，温开水冲服，连续治疗3个月。
基础治疗：他卡西醇软膏（商品名称：萌尔夫 20ug：10g；生产企业：帝人制药株式会社，批准文号：H20090570）
对照组：
白灵片：口服，3次/日，4粒/次
他卡西醇软膏，取适量均匀涂抹于白斑处，并轻柔按摩，2次/日，连续治疗3个月。
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Description for medicine or protocol of treatment in detail：
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Treatment group: the prescription granules of Guben Tongluo prescription were 8g Angelica dahurica 8g Polygonum multiflorum 5g, Tribulus terrestris 8g Tribulus terrestris 8g Zicao 5g, Radix Salviae Miltiorrhizae 8g, Radix Paeoniae Alba 8g, Rhizoma Chuanxiong 8g, peach kernel 8g, safflower 8g a day, take it twice, take it with warm boiled water, and treat it continuously for 3 months. Basic treatment: tacrocarnitol ointment (trade name: Mengerfu 20ug 10g; production enterprise: Teijin Pharmaceutical Co., Ltd., approval number: H20090570)
Control group: Bailing tablet: oral administration, 3 times a day, 4 tablets per time, evenly apply proper amount to leukoplakia, and gently massage twice a day for 3 months.
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纳入标准：
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①中医诊断符合经络瘀阻型伴肝肾不足型白癜风：主要表现为皮肤白斑日久，色瓷白或乳白，边界清楚，或伴有面色发暗、唇甲青紫；舌质紫暗或有瘀斑，脉涩等；或失眠多梦，头晕目眩、腰膝酸软；舌红、少苔，脉细或沉细数等
②西医诊断为稳定期非节段性白癜风，包括：散发型、泛发型、面颈型、肢端型和黏膜型。
③年龄在18-65岁，性别不限，病程≤5年；
④白癜风受累面积必须同时符合以下两点：
-必须存在面部受累，面部受累面积≥0.1%体表面积（BSA）
-全身受累面积≤20%（BSA）
注：计算全身受累面积时，包括面颈部，不包含手、足、黏膜、生殖器部位。
⑤自愿签署知情同意书，愿意并依从访视和治疗计划、实验室检查和治疗前后配合留取照片等研究程序；
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Inclusion criteria
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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
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排除标准：
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①抵抗或不能坚持口服中药者；
②对他卡西醇软膏成分过敏者；
③其他类型包括节段性、混合型、未分类型白癜风的受试者；
④筛选期存在任意1条血常规、肝肾功能异常者；
-血红蛋白水平<9.0g/dL；或红细胞压积<30%；或白细胞绝对计数<3.0×109/L；或中性粒细胞绝对计数(ANC)<1.2×109/L；或血小板计数<100×109/L；
-肝功能损伤(如总胆红素、天冬氨酸氨基转移酶(AST)或丙氨酸氨基转移酶(ALT)>2倍正常值上限)的受试者；
-肾功能异常（肌酐（Scr） 男＞132umol/L,女＞106umol/L）
⑤基线前一段时间内接受过任意1种其他治疗的受试者：
-在基线前4周内接受针对白癜风的任何激光或光学治疗(包括日光浴床)；
-在基线前4周内接受旨在控制/改善白癜风症状的口服或全身用药物(如糖皮质激素、环孢素、甲氨蝶呤、他克莫司等)；
-基线前2周内接受旨在控制/改善白癜风症状的外用治疗(如糖皮质激素、他克莫司、吡美莫司、卡泊三醇等)；
-已接受皮肤褪色治疗；
⑥存在任意1条合并严重疾病，如严重心、脑、肝、肾、造血系统等系统疾病，或恶性肿瘤患者；
-人类免疫缺陷病毒(HIV)或乙型肝炎病毒或丙型肝炎病毒或梅毒相关实验室检查阳性的受试者；
-患有恶性肿瘤或有恶性肿瘤病史(除经充分治疗或切除的皮肤非转移性基底细胞癌或鳞状细胞癌)；
-既往存在或目前存在有临床意义的疾病或异常检查结果或需要使用方案中不允许的药物的疾病。“有意义”定义为研究者认为参与研究会对受试者的安全造成风险或在研究期间疾病/病症加重时会影响疗效或安全性分析；
⑦患有焦虑症、抑郁症等精神类疾病或疾病史，经研究者评估不宜参与本研究的受试者；
⑧处于妊娠期、哺乳期或半年内计划怀孕的女性患者；
⑨皮损局部有红肿、破损或感染者；
-基线访视时患有可能干扰研究药物使用或研究药物疗效评价的其他活动性皮肤病变(银屑病、皮炎、皮肤破溃等)或皮肤感染(细菌、真菌、病毒等)；
-既往发作过两次及以上带状疱疹、发生过一次播散性带状疱疹史或其他研究者认为可能会因参与研究而出现加重的感染史；
-在筛选访视前1个月内存在临床重大感染(需要住院且胃肠外使用抗生素、抗病毒药物、抗真菌药物等治疗3天及以上)或者在筛选期存在正在接受治疗的活动性感染；
-患有活动性结核、正在接受抗结核治疗或首次接受研究药物前1年内接受过抗结核治疗；
⑩其他情况不适合的受试者；
-基线访视前8周内接受过任何活病毒疫苗接种；
-研究者认为可能导致受试者不适合入选研究的其他任何状况。
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Exclusion criteria：
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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;
-received any live viral vaccination within 8 weeks prior to the baseline visit;
-any other condition that the researchers believe may render the subject unsuitable for the study. Research program
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研究实施时间：
Study execute time：
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从From
2021-11-30
至To
2022-12-31
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征募观察对象时间：
Recruiting time：
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从From
2022-03-15
至To
2022-12-31
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