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Study to Evaluate the Effect of "Huashi Runzao Formula" Combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Sjogren's Syndrome: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medicine in the Treatment

Study to Evaluate the Effect of "Huashi Runzao Formula" Combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Sjogren's Syndrome: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medicine in the Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061608
Enrollment
Unknown
Registered
2022-06-29
Start date
2022-06-15
Completion date
Unknown
Last updated
2023-04-03

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

Group A:Huashi Runzao Formula 200mL bid po
Group B:Hydroxychloroquine sulfate tablets 200mg bid po
Group C:Huashi Runzao Formula Placebo 200mL bid po
Group D:Hydroxychloroquine sulfate tablets 200mg bid po

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 75 years; 2. Fulfill the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria, with dry mouth or dry eyes; 3. Fulfill positive autoantibody (ANA or anti-SSA antibody or anti-SSB antibody or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate; 4. Fulfill the dryness and dampness syndrome; 5. Patients were informed and voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with other connective tissue diseases; 2. Glucocorticoids or biological agents have been used within 3 months before enrollment; 3. Pregnancy, preparation for pregnancy or breastfeeding; 4. Patients with severe mental and neurological disorders; 5. Patients with severe disease of heart, brain, lung, liver, kidney, hematopoietic system, etc.; 6. Patients with definite visual field defects, ocular fundus lesions, and severe arrhythmias (atrial fibrillation, atrioventricular block, etc.); 7. Patients are participating in other drug trials.

Design outcomes

Primary

MeasureTime frame
Oral dryness Visual Analogue Scale score;—

Secondary

MeasureTime frame
Eye dryness Visual Analogue Scale score;Fatigue Visual Analogue Scale score;Pain Visual Analogue Scale score;EULAR Sjogren's Syndrome Patient Reported Index score;EULAR Sjogren's Syndrome Disease Activity Index score;Schirmer tests;Saliva flow rates;Immunoglobulin (IgA, IgM, IgG) of serum;Erythrocyte sedimentation rate, ESR;C-reactive protein, CRP;SF-36 health survey;—

Countries

China

Contacts

Public ContactTao Qingwen

China-Japan Friendship Hospital

taoqg1@sina.com+86 13910528490

Outcome results

None listed

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