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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
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,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula
China-Japan friendship hospital
Beijing, Beijing Municipality, China
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.
Time frame: week0、week12
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.
Time frame: week0、week12
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.
Time frame: week0、week4、week8、week12
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
Time frame: week0、week12
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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Time frame: week12
Composite of Relevant Endpoints for Sjogren Syndrome (CRESS)
It includes an assessment of five aspects，at least three out of the five have responded is defined as a response.
Time frame: week 12
erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
conventional inflammatory marks
Time frame: 0week、12week
36-Item Short Form Survey (SF-36)
The higher the score, the better the quality of life
Time frame: week0、week12
serum immunoglobulin（IgA、IgM、IgG）
Compare the differences in the values of various serological indicators between the two groups of patients at the time of enrollment and 12 weeks after treatment, as well as the proportion of improvement and aggravation of serological indicators.
Time frame: week0、week12
Complement (C3, C4）
Compare the differences in the values of various serological indicators between the two groups of patients at the time of enrollment and 12 weeks after treatment, as well as the proportion of improvement and aggravation of serological indicators.
Time frame: week0、week12