A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome

NCT ID: NCT07145060

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-03-31

Brief Summary

This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.

Conditions

Primary Sjögren's Syndrome (pSS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Yiqi Yangyin Formula

The herbal prescription for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks.

Group Type: EXPERIMENTAL

Yiqi Yangyin Formula

Intervention Type: DRUG

Yiqi Yangyin Formula,consists of seven Chinese herbal medicines（Table 1）: Rehmanniae Radix (Sheng Di Huang), Lilium brownii (Bai He), Adenophorae Radix (Nan Sha Shen), Fructus Hordei Germinatus (Sheng Mai Ya), Artemisia annua (Qing Hao), Cimicifuga foetida (Sheng Ma) , and Bupleurum chinense(Chai Hu)

Yiqi Yangyin Formula placebo

The herbal prescription placebo for patients eligible for pSS "Qi-Yin deficiency syndrome" , 200 ml twice daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Yiqi Yangyin Formula placebo

Intervention Type: DRUG

Yiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula

Interventions

Yiqi Yangyin Formula

Yiqi Yangyin Formula,consists of seven Chinese herbal medicines（Table 1）: Rehmanniae Radix (Sheng Di Huang), Lilium brownii (Bai He), Adenophorae Radix (Nan Sha Shen), Fructus Hordei Germinatus (Sheng Mai Ya), Artemisia annua (Qing Hao), Cimicifuga foetida (Sheng Ma) , and Bupleurum chinense(Chai Hu)

Intervention Type: DRUG

Yiqi Yangyin Formula placebo

Yiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula

Intervention Type: DRUG

Other Intervention Names

The treatment group; The control group

Eligibility Criteria

Inclusion Criteria

• Patients aged18-75 years old (including the critical value), gender not limited;
• Patients meeting the classification criteria of primary Sjogren's syndrome in ACR/EULAR 2016;
• Patients with dry mouth VAS ≥4 and ESSDAI score < 5;
• Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and/or hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;
• Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;
• The subjects were informed and voluntarily signed the informed consent form.

Exclusion Criteria

• Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;
• Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;
• Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;
• Patients who are pregnant, preparing for pregnancy or breastfeeding;
• Patients who have used cholinergic drugs or artificial tears/saliva in last 1 week;
• Patients who have used hydroxychloroquine, total glycosides of Paeonia lactide, Iguratimod, cyclophosphamide, cyclosporine A, tacrolimus, and azathioprine in last 1 month;
• Patients who have used glucocorticoids, methotrexate or mycophenolate mofetil in last 3 months;
• Patients who have used Leflunomide in last 6 months;
• Patients who have used rituximab in last 6 months, or have used other biological agents (such as tofacitinib) other than rituximab in last 3 months;
• Patients who have participated in or are currently receiving any other experimental drugs or experimental medical devices within the past three months;
• Other situations that researchers consider ineligible for inclusion (such as cognitive impairment, taking psychotropic drugs).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luo Jing

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tao Qingwen Tao

Role: STUDY_CHAIR

China-Japan Friendship Hospital

Locations

China-Japan friendship hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Luo Jing Luo

Role: CONTACT

luojinggg@sina.com

+8618400664714

Facility Contacts

Liu Zihan Liu

Role: primary

3416309723@qq.com

+86 15290302271

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Other Identifiers

2024-QNQS-07

Identifier Type: -

Identifier Source: org_study_id