Yiqi Yangyin Formula: Yiqi Yangyin Formula,consists of seven Chinese herbal medicines(Table 1): Rehmanniae Radix (Sheng Di Huang), Lilium brownii (Bai He), Adenophorae Radix (Nan Sha Shen), Fructus Hordei Germinatus (Sheng Mai Ya), Artemisia annua (Qing Hao), Cimicifuga foetida (Sheng Ma) , and Bupleurum chinense(Chai Hu)
Yiqi Yangyin Formula placebo: Yiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Primary outcome measure(s)
Unstimulated Whole Saliva flow rate (UWS) — 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.
Trial sites (1)
Facility
City
Region
Status
China-Japan friendship hospital
Beijing
Beijing Municipality
More China-Japan Friendship Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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