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A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules

A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003741
Enrollment
Unknown
Registered
2020-08-26
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Sjogren syndrome

Interventions

Sponsors

Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. SS patients who meet the above diagnostic criteria of traditional Chinese and Western medicine. 2. Patients with moderate activity (essdai score 4-6). 3. Age of subjects: 18-65 years old. 4. Patients who have not used traditional Chinese medicine in the past, or have been interrupted for more than 2 months. 5. Women of childbearing age agreed to take effective contraceptive measures during the trial. 6. Patients who voluntarily sign informed consent and comply with the requirements of the study protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with severe or uncontrolled cardiovascular, liver, kidney, brain and hematopoietic system. 2. Patients with other connective tissue diseases, drug-induced lupus syndrome, tuberculosis and psychosis. 3. Pregnant or lactating women. 4. Patients with ALT or ast more than twice the upper limit of normal value, or total bilirubin greater than the upper limit of normal value. 5. Patients with allergic constitution.

Design outcomes

Primary

MeasureTime frame
Tear film rupture time;ESR;Corneal fluorescent stain;Serum IgG;Schirmer's test;Saliva flow rate;Serum ß2 microglobulin;CRP;RF;

Secondary

MeasureTime frame
Drug side effects;C3;Hormone withdrawal;C4;Number of relapses, degree of progress;

Countries

China

Contacts

Public ContactDan Wang

Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

shangrilear@163.com+86 18930755925

Outcome results

None listed

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