Sjögren's Syndrome
Conditions
Interventions
Control group:Conventional Western medicine medication regimen (stable dosage and type of medication for at least 12 weeks) or cessation of medication for at least 12 weeks or no concomitant medicatio
When thirsty, drink plain water and control the daily water intake between 500ml and 1000ml
The treatment period is 4 weeks.
Intervention group:Treat with Shengjin Runkou Drink for 4 weeks
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the International Classification (Diagnosis) criteria for Sjogren's Syndrome in 2002/2016, and the course of the disease is less than 10 years; 2. Patients who meet the criteria for traditional Chinese medicine syndrome of Yin deficiency and Jin deficiency; 3. Age range from 18 to 65 years old; 4. The patient agrees to receive one month of treatment and examination, and signs an informed consent form; 5. Combination medication situation:1) No concomitant medication; or 2) Stop medication for at least 12 weeks; or 3) The amount and types of medication drinks should be stable for at least 12 weeks (including non steroidal anti-inflammatory drugs, oral corticosteroids, pilocarpine, methotrexate, cyclophosphamide, cyclosporine, azathioprine, hydroxychloroquine sulfate, artificial tears, and traditional Chinese patent medicines and simple preparations, including tripterygium wilfordii drink, total glucosides of paeony capsules, etc.).
Exclusion criteria
Exclusion criteria: 1. Apply traditional Chinese medicine decoction or granules for treatment within 3 months before enrollment; 2. Severe organ lesions in important organs such as the heart, liver, kidney, and brain that are not caused by this disease; 3. Patients with concomitant neurological damage, glomerular acidosis, interstitial pneumonia, liver damage, and severe damage (such as severe hypokalemia); 4. Pregnant, lactating, or planned pregnant women, or women of childbearing age who are unwilling to take reliable contraceptive measures during the study period; 5. Individuals who are receiving any other experimental drugs or experimental medical devices; 6. Researchers believe that patients have serious risks to patient safety, may confuse research results, or may have accompanying diseases (such as neurological or psychiatric disorders) that affect the completion of this study, or any other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dry mouth VAS score;Non irritating saliva flow rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESSDAI score;Traditional Chinese Medicine Syndrome Investigation Form score;Oral Health Impact Scale (OHIP-14) score;Hospital Anxiety and Depression Scale (HAD) score;Parotid gland ultrasound (hocevar-48 score evaluation);serological changes (immunological indicators: IgA, IgM, IgG, RF, inflammatory indicators CRP, ESR); | — |
Countries
China
Contacts
Public ContactXinyao Zhou; Wenjing Liu
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed