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Efficacy and safety of Qingmai Runzao tea in the treatment of primary Sjogren's syndrome

Efficacy and safety of Qingmai Runzao tea in the treatment of primary Sjogren's syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000464
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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:Qing Mai Run Zao Tea +Hydroxychloroquine Sulfate Tablets 0.2 bid
Control group:Placebo +Hydroxychloroquine Sulfate Tablets 0.2 bid

Sponsors

Qinghai Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Only those who meet all of the following criteria are eligible for inclusion: 1) In accordance with the 2002 International classification of Sjogren's syndrome (diagnostic criteria); 2) Age 18-75 years old; 3) Symptoms of dry mouth or dry eyes, and VAS=40mm; 4) Patients agreed to be treated and examined for 4 weeks and signed informed consent; 5) Hydroxychloroquine sulfate should be continued for at least 4 weeks and other DMARDs should be discontinued for at least 6 months 6) Withdrawal of immunosuppressive agents, biological agents, and gland agonists for at least 6 months 7) Discontinuation of steroid therapy for at least 4 weeks 8) Not taking Chinese medicine preparations such as Tripterygium wilfordii tablets, total glucosides of paeony or Chinese medicine decoction within 2 weeks

Exclusion criteria

Exclusion criteria: Any of the following conditions shall be excluded: 1 pregnant or lactating women; 2 patients with secondary Sjogren's syndrome; 3 complicated with serious heart, liver, kidney, brain and other important organ lesions; (4) Complicated with nervous system damage, glomerular acidosis, interstitial pneumonia, liver damage, severe damage (such as severe hypokalemia);

Design outcomes

Primary

MeasureTime frame
European league against rheumatism Sjögren's syndrome patient reported index,ESSPRI;—

Secondary

MeasureTime frame
Visual Analogue Scale,VAS;Salivary secretion flow rate;Schirmer; Immunoglobulin A/ Immunoglobulin M / Immunoglobulin G; C-Reactive Protein; Erythrocyte Sedimentation Rate;—

Countries

China

Contacts

Public ContactHanman

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

hanman111@126.com15011565229

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026