A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Unstimulated Whole Saliva flow rate (UWS)
研究概览
简要总结
This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged18-75 years old (including the critical value), gender not limited;
- •Patients meeting the classification criteria of primary Sjogren's syndrome in ACR/EULAR 2016;
- •Patients with dry mouth VAS ≥4 and ESSDAI score < 5;
- •Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
- •Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;
- •The subjects were informed and voluntarily signed the informed consent form.
排除标准
- •Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;
- •Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;
- •Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;
- •Patients who are pregnant, preparing for pregnancy or breastfeeding;
- •Patients who have used cholinergic drugs or artificial tears/saliva in last 1 week;
- •Patients who have used hydroxychloroquine, total glycosides of Paeonia lactide, Iguratimod, cyclophosphamide, cyclosporine A, tacrolimus, and azathioprine in last 1 month;
- •Patients who have used glucocorticoids, methotrexate or mycophenolate mofetil in last 3 months;
- •Patients who have used Leflunomide in last 6 months;
- •Patients who have used rituximab in last 6 months, or have used other biological agents (such as tofacitinib) other than rituximab in last 3 months;
- •Patients who have participated in or are currently receiving any other experimental drugs or experimental medical devices within the past three months;
- •Other situations that researchers consider ineligible for inclusion (such as cognitive impairment, taking psychotropic drugs).
研究组 & 干预措施
Yiqi Yangyin Formula
The herbal prescription for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks.
干预措施: Yiqi Yangyin Formula (Drug)
Yiqi Yangyin Formula placebo
The herbal prescription placebo for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks.
干预措施: Yiqi Yangyin Formula placebo (Drug)
结局指标
主要结局
Unstimulated Whole Saliva flow rate (UWS)
时间窗: week0、week12
Before the measurement, the participants should avoid eating, drinking, smoking, brushing teeth. and sit still for 10 minutes to collect all the saliva that flows out within 15 minutes in a clean container. The volume will be measured and the salivary secretion rate per unit time will be calculated, which is the UWS (ml/min). UWS ≤ 0.1 ml/min is defined as low UWS.
次要结局
- bilateral Schirmer's test(week0、week12)
- EULAR Sjögren Syndrome Patient Reported Index (ESSPRI)(week0、week4、week8、week12)
- EULAR Sjögren syndrome disease activity index (ESSDAI)(week0、week12)
- Sjögren's Tool for Assessing Response (STAR)(week12)
- Composite of Relevant Endpoints for Sjogren Syndrome (CRESS)(week 12)
- erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)(0week、12week)
- 36-Item Short Form Survey (SF-36)(week0、week12)
- serum immunoglobulin（IgA、IgM、IgG）(week0、week12)
- Complement (C3, C4）(week0、week12)
研究者
Luo Jing
Associate chief physician
China-Japan Friendship Hospital