primary Sjögren's syndrome
Conditions
Interventions
Intervention group:CheRe CunJin Gao: 20g once, three times on one day for 12 weeks
Control group:Placebo: 20g once, three times on one day for 12 weeks
Sponsors
Chongqing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Meeting all the following criteria will be considered for inclusion in the trial: (1)meets the diagnostic criteria for pSS in Western medicine (2)meets TCM diagnosis and the standard of TCM syndrome of dryness-heat caused by Yin-deficiency (3)days=3 in the one-week inclusion period with the VAS score of the main symptom (dry mouth and dry eye)=4 (4)between 18 and 70 years of age (5)willing to participate in the trial and sign the informed consent (6)has the read ability at a certain extent
Exclusion criteria
Exclusion criteria: Meeting any one of the following criteria will not be enrolled: (1)secondary Sjögren's syndrome (2)have been having severe primary cardiovascular disease, liver disease (and/or the value of ALT> 1.5 times of the normal value), kidney diseases, hematological diseases, lung diseases, or other existing serious diseases that affect their survival, such as cancer or AIDS (3)participants with severe primary disease or underlying medication affecting efficacy assessment (4)being pregnant or planning to be pregnant, or at the period of being lactation (5)participants who are allergic to the medicine (6)participants who are unable to cooperate with the study, such as intellectual disability, mental illness and so on (7)participants who participate in any other clinical trials currently or in 4 weeks before recruitment (8)A suspected or existing history of alcohol or drug abuses, or other conditions that reduce or complicate enrollment from the investigator's judgment, such as frequent changes in the work environment and so on, causing the loss of follow-up (9)participants had used corticosteroids,immunosuppressive agents,biological agents or cholinergic drug within 3 months prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESSPRI;Schirmer's test;Salivary flow rate;VAS of dry mouth and dry eye ; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS of fatigue, pain and general dryness ;ESSDAI;TCM syndrome score;Laboratory indicator (ESR, CRP, Ig);Summated Xerostomia Inventory;Ocular Surface Disease Index;SF-36; | — |
Countries
China
Contacts
Public ContactBin Wu
Chongqing Hospital of Traditional Chinese Medicine
Outcome results
None listed