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

NCT07145060 | Not Yet Recruiting

• 1 other identifier: 2024-QNQS-07
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Unstimulated Whole Saliva flow rate (UWS)

  Before the measurement, the participants should avoid eating, drinking, smoking, brushing teeth. and sit still for 10 minutes to collect all the saliva that flows out within 15 minutes in a clean container. The volume will be measured and the salivary secretion rate per unit time will be calculated, which is the UWS (ml/min). UWS ≤ 0.1 ml/min is defined as low UWS.

  week0、week12

Secondary Outcomes (9)

• bilateral Schirmer's test

  week0、week12

• EULAR Sjögren Syndrome Patient Reported Index (ESSPRI)

  week0、week4、week8、week12

• EULAR Sjögren syndrome disease activity index (ESSDAI)

  week0、week12

• Sjögren's Tool for Assessing Response (STAR)

  week12

• Composite of Relevant Endpoints for Sjogren Syndrome (CRESS)

  week 12

Study Arms (2)

Yiqi Yangyin Formula

EXPERIMENTAL

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

Drug: Yiqi Yangyin Formula

Yiqi Yangyin Formula placebo

PLACEBO COMPARATOR

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

Drug: Yiqi Yangyin Formula placebo

Interventions

Yiqi Yangyin Formula 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)

Also known as: The treatment group

Yiqi Yangyin Formula

Yiqi Yangyin Formula placebo DRUG

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

Also known as: The control group

Yiqi Yangyin Formula placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (12)

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• Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017 Jun 27;167(2):112-121. doi: 10.7326/M16-2977. Print 2017 Jul 18.

  PMID: 28654980 BACKGROUND

• Fox RI, Fox CM, Gottenberg JE, Dorner T. Treatment of Sjogren's syndrome: current therapy and future directions. Rheumatology (Oxford). 2021 May 14;60(5):2066-2074. doi: 10.1093/rheumatology/kez142.

  PMID: 31034046 BACKGROUND

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Study Officials

• Tao Qingwen Tao

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Luo Jing Luo

CONTACT

+8618400664714; luojinggg@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)