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.
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 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;
Parallel
Yiqi Yangyin Formula
DrugYiqi 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
DrugYiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula
Unstimulated Whole Saliva flow rate (UWS)
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.
bilateral Schirmer's test
Without surface anesthesia, in a quiet and dim environment, bend the standard Schirmer filter paper at the scale and gently place it on the edge of the lower temporal eyelid of the subject. Instruct the subject to gently close their eyes and keep the filter paper for 5 minutes. After 5 minutes, remove the filter paper and measure the wet length. Schirmer≤5 mm/5 min indicates the presence of dry eye syndrome.
EULAR Sjögren Syndrome Patient Reported Index (ESSPRI)
The ESSRPI is a patient-reported index for Sjogren's syndrome, which includes scores for sjogren's symptoms, limb pain, and physical fatigue. The weights of the three aspects are the same, and each aspect's score ranges from 0 to 10. ESSPRI is defined as the average of these three aspects, with a score range of 0 to 10. The higher the value, the more severe the condition. A symptom state of less than 5 is acceptable to the patient, while a symptom state of ≥5 is unsatisfactory to the patient.
EULAR Sjögren syndrome disease activity index (ESSDAI)
Low activity is defined as ESSDAI \< 5 points, moderate activity as 5≤ESSDAI≤13 points, and high activity as ESSDAI≥14 points
Sjögren's Tool for Assessing Response (STAR)
It includes the assessment of ESSDAI system involvement, the subjective perception assessment of ESSPRI patients, the functional changes of salivary glands and lacrimal glands, and the evaluation of serological indicators for treatment response. A total score of ≥5 is considered a treatment response.
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