Primary Sj?gren's syndrome
Conditions
Interventions
Sponsors
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with SS-related symptoms/signs can be diagnosed as SS if the following 3 objective tests meet 2 or more items 1. Serum anti-SSA and (or) anti-SSB antibody (+), or rheumatoid factor positive with ANA >=1:320; 2. The pathology of the labial glands showed lymphocyte foci >=1/4mm2 (at least 50 lymphocytes gathered in the 4mm2 tissue; 3. OSS (ocular staining score) for keratoconjunctivitis sicca: Staining score >=3 (the patient is not currently using eye drops due to glaucoma, and there is no history of corneal surgery and eye and face plastic surgery in the past 5 years); Must be excluded: history of cervical, head and face radiotherapy, hepatitis C virus infection, AIDS, sarcoidosis, amyloidosis, graft versus host disease, IgG4-related diseases. TCM syndrome differentiation standard According to the pathological characteristics of primary Sjogrens syndrome and the functional characteristics of Runzao Decoction to invigorate qi, nourish fluid, nourish yin and moisturize dryness, and give consideration to specimens, the syndrome of deficiency of qi and body fluid was selected as the observation syndrome type (refer to "Guiding Principles for Clinical Research of New Chinese Medicines" and hygiene The Ministry of "Traditional Chinese Medicine Syndrome Classification Standards" was formulated). The main symptoms: dry mouth and throat, dry eyes, fatigue, fatigue, abnormal tongue (tongue is bright red with little fluid, cracked, little or no coating, or tongue is fat and large). Secondary symptoms: frequency of drinking, dry skin, dry nasal cavity; blurred vision, appetite, abdominal distension after eating, weak bowel movements, abnormal stools, or dry or loose stools. Pulse condition: Shen thin and weak. Tongue appearance: Except for light red and chapped, or the tongue is fat, or dark purple or ecchymosis. It can be diagnosed with 4 main symptoms; or 2 main symptoms plus 2 or more minor symptoms. In line with the 2012 ACR Sjogrens syndrome (diagnostic) criteria and the 2002 primary Sjogrens syndrome diagnostic criteria, the subject has clinical manifestations of spleen-qi deficiency and dryness, which can be diagnosed as pSS Qi-deficiency syndrome. Case inclusion criteria 1) Aged 18 to 75 years old; 2) Primary Sjogren's syndrome that meets the above diagnostic criteria of Western medicine; 3) Primary Sjogrens syndrome that meets the above-mentioned TCM syndrome differentiation criteria; 4) Be informed and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Case exclusion criteria 1) Excluding secondary Sjogren's syndrome caused by mixed connective tissue disease, rheumatoid arthritis, and systemic lupus erythematosus; 2) Exclude those who belong to the category of Diabetes in Chinese medicine but do not meet the diagnostic criteria of Western medicine for Sjogrens syndrome; 3) Pregnant or lactating women. 4) People with allergies or allergic to the components of the medicine. 5) Patients with severe primary diseases such as heart, brain, liver, kidney, hematopoietic system, etc. 6) Mental patients. 7) It is suspected that there is a history of alcohol or drug abuse, or other medical history that reduces the possibility of enrollment or complicates enrollment according to the judgment of the investigator, such as frequent changes in the work environment, which may easily cause loss to follow-up. 8) Those who have participated in or are participating in other drug clinical trials within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer Test;BUT tear film rupture time;Saliva flow rate;Score of the number of nights drinking water every night;Dry mouth score;Dry Eye Score;Nasal dryness score;Skin dryness score;Improvement degree of spleen deficiency symptoms; | — |
Countries
China
Contacts
Public ContactKOU Qiuai
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Outcome results
None listed