Multi-center, randomized, double blind, placebo controlled study of the efficacy and safety of TGP in the treatment of pSS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002325

Enrollment

Unknown

Registered

2012-05-30

Start date

2012-03-20

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Primary Sj?gren's Syndrome, pSS

Interventions

Treatment:TGP capsules (TGP)

Control:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Meet the following conditions: 1. Understanding the whole process of the study, voluntary participation and signed the informed consent; 2. Diagnosed according to Classification criteria for Sjigren's syndrome 2002; 3. Patients aged 18 to 65 years (to the date of screening); 4. Patients with dry mouth, dry eye symptoms; 5. Patients with positive autoantibodies (one positive of ANA, anti-SSA, anti-SSB, RF) or ESR> 25mm/h or high immune hypergammaglobulinemia; 6. Patients with no serious systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, chronic atrophic gastritis, autoimmune liver disease; 7. Not participating in any drug trials in three months before enrolled.

Exclusion criteria

Exclusion criteria: One of the following is not included in this study: 1. Pregnant women, ready to pregnant or lactating women; 2. Stimulated Salivary glands flow rate =133mmol/L (1.5mg/dL); 5. Patients with white blood cells <3.0*10^9/L, or a definite anemia (hemoglobin less than 80g / L), or platelets <80*10^9/L, or other blood disease; 6. Patients with chronic diarrhea, or peptic ulcer nearly 1 year; 7. Patients with uncontrolled severe hypertension, metabolic diseases (eg diabetes); 8. Patients suffering from malignant tumor; 9. Patients suffering from acute and chronic infectious diseases; 10. Patients with serious arrhythmia by ECG; 11. The test drug allergy; 12. Mental disorders, history of alcohol abuse, drug or other substance abuse; 13. Patients with other connective tissue disease diagnosed; 14. Patients used immunosuppressants, corticosteroids, biological agents, glandular secretion agonists three months before enrollment; 15. During the study accompanying with the following drugs: immunosuppressive agents, glucocorticoids, biologics, glandular secretion agonists; 16. Other cases which researchers believe that can not enroll.

Design outcomes

Primary

Measure	Time frame
ESSPR;ESSDA;	—

Countries

China

Contacts

Public ContactWang Guochun

guochunwang@hotmail.com+86 13910729602

Outcome results

None listed

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