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A double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndrome

A double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005441
Enrollment
Unknown
Registered
2014-08-10
Start date
2014-01-01
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 Sjogren syndrome

Interventions

treatment group:hydroxychloroquine+Jiedu Tongluo Shengjin Decoction

Sponsors

Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: -Age 18-65 years old -In line with the 2002 European and American Collegiate classification standard of Sjogren syndrome 1. Diagnosis and differentiation of Chinese medicine conforms to diagnosis and typing standard of dry disease in the "Shanghai City TCM disease diagnosis and treatment routine" (deficiency of fluid of lung and stomach, yin deficiency of liver and kidney, deficiency of both qi and yin); 2. No visceral involving; 3. Baseline 8 weeks have not received glucocorticoid and immunosuppressive therapy.

Exclusion criteria

Exclusion criteria: 1. Patients under the age of 18 years or more than 65 years old; 2. Patients who use corticosteroids and other immunosuppressive in nearly 1 months; 3. Combined with other connective tissue diseases; 4. The presence of Ophthalmology taboos of using hydroxychloroquine, such as retinitis pigmentosa; 5. Lesions in other organ involvement involving; 6. Combined with cardiac conduction block (PR more than at least 0.2 sec and QRS more than at least 0.08 sec); 7. Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system severe primary diseases; 8. Allergy and allergic to many medicines; 9. Pregnancy or prepare for pregnancy, and lactation woman; 10. The patient cannot cooperate or are in other drug trials.

Design outcomes

Primary

MeasureTime frame
subjective indicators of dry mouth and dry eye;ESSDAI;the secretion of saliva flow without stimulating;Schirmer's test;Corneal fluorescein staining;Breakup time of tear film;

Secondary

MeasureTime frame
ESR;CRP;C3, C4;IgA, IgG, IgM;RF;

Contacts

Public ContactLuan Xue
xelco@163.com+86 18930568151

Outcome results

None listed

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