研究疾病:
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银屑病
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研究疾病代码:
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Target disease:
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psoriasis
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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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II期临床试验
Phase II clinical trial
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研究目的:
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从“湿与银屑病”的角度出发,治则上提出要重视“祛湿”,选用临床上疗效切确的验方作为研究载体,严格采用随机双盲对照试验的临床研究试验设计开展符合国际规范的临床评价研究,促进临床处方的开发和成果转化。
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Objectives of Study:
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From the perspective of "dampness and psoriasis", it is proposed to pay attention to "removing dampness" in the treatment principle, select the clinically effective prescription as the research carrier, strictly adopt the clinical research trial design of randomized double-blind controlled trial, carry out clinical evaluation research in line with international norms, and promote the development of clinical prescriptions and the transformation of achievements.
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药物成份或治疗方案详述:
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(1)干预措施
试验组1:固本祛湿化瘀方+参苓白术散口服
试验组2:固本祛湿化瘀方+安慰剂口服
试验组3:参苓白术散+安慰剂口服
对照组:安慰剂+安慰剂口服
固本祛湿化瘀方的药物组成:主要由黄芪、赤芍、土茯苓等9味中药组成,由于当前本方处于国家发明专利申请状态,暂不便公开全部中药组分,待获得专利授权后即可公开。
参苓白术散的药物组成:人参、茯苓、白术(炒)、山药、白扁豆(炒)、莲子、薏苡仁(炒)、砂仁、桔梗、甘草。
安慰剂成分:辅料、苦味素及香料等。
(2)基础用药:
治疗期给予患者局部10%浓度的尿素软膏按需外用,采集皮肤菌群前要停用尿素软膏12小时。
(3)应急性用药:
受试者出现忍受不了的瘙痒时使用紧急用药,予应急用药抗组胺类药物(盐酸西替利嗪片)口服,并记录用药时间及用量。
受试者颜面部皮疹出现突然加重,予应急用药他克莫司或他卡西醇外用,并记录用药时间及用量。
(4)疗程
参照国内外文献并结合本课题组前期研究结果,疗程定为16周,随访时间12周。
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Description for medicine or protocol of treatment in detail:
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(1) Intervention measures
Experimental group 1: Guben Qushi Huayu Decoction + Shenling Baizhu powder orally
Experimental group 2: Guben Qushi Huayu formula + placebo orally
Experimental group 3: Shenling Baizhu powder + placebo orally
Control group: placebo + placebo orally
Drug composition of Guben Qushi Huayu Recipe: it is mainly composed of 9 traditional Chinese medicines such as Astragalus membranaceus, red peony root and poria cocos. Since we are currently in the state of national invention patent application, it is inconvenient to disclose all traditional Chinese medicine components temporarily, which can be disclosed after obtaining patent authorization.
The drug composition of Shenling Baizhu powder: ginseng, Poria cocos, Atractylodes macrocephala (fried), yam, white lentil (fried), lotus seed, coix seed (fried), Amomum villosum, Platycodon grandiflorum and licorice.
Placebo ingredients: excipients, bitter and spices.
(2) Basic medication:
During the treatment period, the patients were given local 10% urea ointment for external use as needed. The urea ointment should be stopped for 12 hours before collecting skin flora.
(3) Emergency medication:
In case of intolerable pruritus, the subjects used emergency medication, took the emergency antihistamines (cetirizine hydrochloride tablets) orally, and recorded the medication time and dosage.
When the skin rash on the face and face of the subjects suddenly worsened, they were given tacrolimus or taccathinol for external use, and the medication time and dosage were recorded.
(4) Course of treatment
Referring to domestic and foreign literature and combined with the previous research results of our research group, the treatment course was set as 16 weeks and the follow-up time was 12 weeks.
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纳入标准:
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①年龄18-70岁,男女不限;②符合稳定期斑块型银屑病诊断标准的患者;③皮损程度达到中度(3≤PASI<10或3%≤BSA<10%);④符合湿证的证候诊断标准;⑤签署知情同意书者。
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Inclusion criteria
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1.The age is 18-70 years old, both male or female; 2.The patients who meet the diagnostic criteria of stable plaque psoriasis; 3.The degree of skin lesions was moderate (3 ≤ PASI < 10 or 3% ≤ BSA < 10%); 4.The patients who meet the diagnostic criteria of dampness syndrome; 5.Patients with informed consent.
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排除标准:
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①点滴型、反向型、关节型、脓疱型、红皮病型银屑病,或进行期、消退期的寻常型银屑病。②妊娠、哺乳期妇女,或1年内计划妊娠者。③合并有呼吸系统、循环系统、消化系统、内分泌系统和泌尿系统等严重原发性疾病,常规用药无法控制的患者;合并严重感染、肝炎、肺结核、淋巴细胞增生、造血系统异常、肿瘤的患者;合并有严重水、电解质及酸碱平衡紊乱的患者;合并原发或继发性免疫缺陷及超敏患者;或临床检测指标属于以下几种情况之一的患者:谷丙转氨酶或谷草转氨酶增高>1.5倍正常值上限;肌酐增高>1.5倍正常值上限;血红蛋白增高>20g/L正常值上限;血小板计数减少<75.0×10e9/L;白细胞计数减少<3.0×10e9/L;血钾升高>5.5mmol/L或降低<3mmol/L,或其他实验室检查异常研究者判断不适合参与此试验的患者。④已知对本研究中所用药物过敏及含有相关药物成分过敏的患者。⑤正在参加其它药物临床试验者或1个月内参加过其它临床试验者。⑥研究者认为不适合纳入的患者。
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Exclusion criteria:
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1.Drip type, reverse type, joint type, pustular type, erythrodermic psoriasis, or psoriasis vulgaris in progressive stage and regression stage. 2.Pregnant or lactating women, or those planning pregnancy within 1 year. 3.Patients with severe primary diseases such as respiratory system, circulatory system, digestive system, endocrine system and urinary system, which can not be controlled by conventional drugs; Patients with severe infection, hepatitis, pulmonary tuberculosis, lymphocyte proliferation, abnormal hematopoietic system and tumor; Patients with severe disorders of water, electrolyte and acid-base balance; Patients with primary or secondary immunodeficiency and hypersensitivity; Or patients whose clinical test indexes belong to one of the following situations: the increase of alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal value; The increase of creatinine > 1.5 times the upper limit of normal value; Hemoglobin increase > 20g / L, upper limit of normal value; Thrombocytopenia < 75.0 × 10e9/L Decrease in leukocyte count < 3.0 × 10e9/L The increase of blood potassium is more than 5.5mmol/l or the decrease is less than 3mmol / L, or other abnormal laboratory tests. The researchers judge that it is not suitable for patients to participate in this test. 4.Patients who are known to be allergic to the drugs used in this study and those containing related drug components. 5.Those who are participating in other drug clinical trials or have participated in other clinical trials within 1 month. 6.Patients considered unsuitable for inclusion by the researchers.
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研究实施时间:
Study execute time:
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从From
2022-01-01
至To
2026-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-04-01
至To
2026-06-30
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