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Canceled by the investigator United metformin hydrochloride tablets of atorvastatin treatment efficacy and safety evaluation of primary Sjgren's syndrome

United metformin hydrochloride tablets of atorvastatin treatment efficacy and safety evaluation of primary Sjgren's syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011496
Enrollment
Unknown
Registered
2017-05-26
Start date
2017-05-25
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren 's syndrome

Interventions

Experimental group:Metformin 250mg 3 times / day
atorvastatin tablets 10mg 1 time / day
Control:Traditional DMARDs

Sponsors

Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. aged 18 to 65 years old, men and women are not limited; 2. in line with the 2002 international classification of primary Sjogren's syndrome (diagnostic) standards 3. Screening of subjects must meet the following laboratory tests: Hb 85g/L; WBC 3*10^9/L; neutrophils 1.5*10^9/L; platelets 100*10^9/L; 2 transaminase normal upper limit of 2 times; creatinine 120mol/L (1.4 Mg/dl); 4. Th17 is higher than the normal range or Treg decrease or Th17 / Treg ratio imbalance; 5. Pregnancy tests for women of childbearing age were negative and agreed to take effective contraceptive measures during the trial period and within 6 months after the end of the trial; 6. screening subjects subject to body mass index (BMI) 20; 7. subjects can be regularly referral.

Exclusion criteria

Exclusion criteria: (1) disabled, bed rest, wheelchair dependent, life can not take care of themselves; (2) combined with other rheumatic diseases; (3) screening within 5 years before or now suffering from malignant tumors; (4) subjects with severe acute, chronic or recurrent infections (eg pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.); (5) suffering from active hepatitis or a history of hepatitis C; (6) HIV infection; (7) such as lymphoma and other lymphoproliferative diseases; (8) multiple sclerosis or other central nervous demyelinating disease; had or now suffering from congestive heart failure; (9) have serious, progressive, uncontrolled liver, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerve and brain diseases; (10) Doctors evaluate that patients are not fit to participate in this study.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms;Pathology of the labial gland;ANA;SS-A;SS-B;IgG;IgA;IgM;ESR;CRP;Th17;Treg;ESSDAI score.;Peripheral blood cell count;liver function;Renal function;blood sugar;Blood lipids;Myocardial enzymes;

Countries

China

Contacts

Public ContactWang Yongfu

Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital

18047211500@163.com+86 18047211500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026