primary Sjögren's syndrome
Conditions
Interventions
Placebo control group:Take orally, Chere Cunjin Gao Simulator (placebo), 20g each time, 3 times daily (afer morning, lunch and dinner) for 12 weeks
High-dose group of Chere Cunjin Gao:Take orally high-dose Chere Cunjin Gao 20g each time 3 times daily (afer morning lunch and dinner) for 12 weeks
Low-dose group of Chere Cunjin Gao:Take orally, low-dose Chere Cunjin Gao, 20g each time, 3 times daily (afer morning, lunch and dinner) for 12 weeks
Sponsors
Chongqing Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for primary Sjögren's syndrome (pSS) in Western medicine; 2.Meet the TCM syndrome differentiation criteria for Zao Bi of yin deficiency with dryness-heat type; 3.VAS score for main symptoms (mouth or eye dryness)=4; 4.Age =18 and =75 years; 5.The informed consent process complies with ethical requirements and the subject or legal representative has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with secondary Sjögren's syndrome; 2.Individuals with severe cardiovascular or cerebrovascular diseases (myocardial infarction post-coronary stent implantation cerebral infarction cerebral hemorrhage) liver diseases (ALT and/or AST > 1.5 times the upper reference limit) kidney diseases (abnormal renal function and/or urine protein > + and/or renal tubular acidosis) hematological disorders (white blood cells < 3×10^9/L and/or hemoglobin < 90g/L and/or platelets < 75×10^9/L) lung diseases (chest imaging consistent with structural lung damage (excluding old tuberculosis) or space-occupying lesions) or other severe life-threatening diseases such as tumors or AIDS; 3.Individuals who have used glucocorticoids (such as hydrocortisone cortisone prednisone prednisolone methylprednisolone dexamethasone betamethasone) immunomodulators (such as total glucosides of paeony tripterygium glycosides) immunosuppressants (such as methotrexate iguratimod leflunomide sulfasalazine hydroxychloroquine thalidomide cyclophosphamide azathioprine cyclosporine mycophenolate mofetil) biological agents (such as etanercept infliximab adalimumab golimumab tocilizumab rituximab tofacitinib citrate) or glandular secretion stimulants (such as pilocarpine) within one month prior to inclusion; 4.Individuals with diabetes mellitus; 5.Those presenting with chronic diarrhea symptoms (=4 times per day); 6.Women who are pregnant planning to become pregnant or are lactating; 7.Individuals with a known allergy to the investigational drug or its components; 8.Those currently participating or having participated in other drug clinical trials within the past 4 weeks; 9.Individuals with a suspected or confirmed history of alcohol or drug abuse; 10.Those with other conditions that may reduce the likelihood of enrollment or complicate the enrollment process such as frequent changes in work environment that may lead to loss to follow-up; 11.Patients unable to cooperate with the study such as those with blindness deafness mutism intellectual disabilities or psychiatric disorders; 12.Patients deemed by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EULAR Sjogren's Syndrome Patient Reportsd Index (ESSPRI); | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Score for Fatigue;Single TCM Syndrome Score;Schirmer's Test;VAS Score for Pain;Salivary Flow Rate Test;C Reactive Protein (CRP);TCM Syndrome Score;Immunoglobulin G (IgG);VAS Score for Mouth Dryness;EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI);VAS Score for Eye Dryness;Erythrocyte Sedimentation Rate (ESR); | — |
Countries
China
Contacts
Public ContactBin Wu
Chongqing Traditional Chinese Medicine Hospital
Outcome results
None listed