TCTR20230116003已完成1 期
Efficacy and Safety of acupuncture in the treatment of primary Sjogren's syndrome: a randomized controlled trial
Wei Liu0 个研究点目标入组 138 人开始时间: 2023年1月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •(1) Age greater than or equal to 18 and less than or equal to 75
- •(2) Patient with a disease course of less than 10 years;
- •(3) Patients without fundus lesions;
- •(4) Hydroxychloroquine (HCQ) was taken before the test, the dosage was stable, and the treatment time was greater than or equal to 8 weeks;
- •(5) EULAR Sjogren's syndrome patient reported index (ESSPRI) score greater than or equal to 4 points;
- •(6) Salivary flow rate > 0 mL/15min;
- •(7) Schirmer test greater than or equal to 1 mm/5 min;
- •(8) Patients agreed to join the study and signed the informed consent form.
排除标准
- •(1) Secondary Sjogren's syndrome or combined with other connective tissue diseases, such as systemic lupus erythematosus and rheumatoid arthritis;
- •(2) Suffering from severe systemic diseases, such as pulmonary interstitial fibrosis and progressive renal damage, serious renal or liver dysfunction;
- •(3) Patients with immunodeficiency syndrome;
- •(4) Accompanied by severe heart, brain, liver, kidney, and other important organs or neuropathy;
- •(5) Patients with mental illness or unconsciousness;
- •(6) Patients with a history of alcohol or drug abuse;
- •(7) Patients who received immunosuppressants, glucocorticoids, traditional Chinese medicine, and other treatments other than hydroxychloroquine sulfate within four weeks before enrollment;
- •(8) Patients with contraindications to hydroxychloroquine sulfate;
- •(9) Platelet count < 50*109;
- •(10) Pregnant, lactating, or currently planned pregnant women;
- •(11) Participating in other clinical trials within three months before the trial or currently;
- •(12) Patients with contraindications to acupuncture (metal allergy and skin damage at relevant acupoints).
研究者
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