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Not yet recruiting NCT07145060

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

No phase Interventional Primary Sjögren's Syndrome (pSS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yiqi Yangyin Formula, Yiqi Yangyin Formula placebo.
Who it may be relevant to
Registry conditions: Primary Sjögren's Syndrome (pSS). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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)
  • 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

Primary outcome measures

  • Unstimulated Whole Saliva flow rate (UWS) [Time frame: week0、week12]
Secondary outcome measures (9)
  • bilateral Schirmer's test [Time frame: week0、week12]
  • EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) [Time frame: week0、week4、week8、week12]
  • EULAR Sjögren syndrome disease activity index (ESSDAI) [Time frame: week0、week12]
  • Sjögren's Tool for Assessing Response (STAR) [Time frame: week12]
  • Composite of Relevant Endpoints for Sjogren Syndrome (CRESS) [Time frame: week 12]
  • erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) [Time frame: 0week、12week]
  • 36-Item Short Form Survey (SF-36) [Time frame: week0、week12]
  • serum immunoglobulin（IgA、IgM、IgG） [Time frame: week0、week12]
  • Complement (C3, C4） [Time frame: week0、week12]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan friendship hospital — Beijing

Publications

  • Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a cons PMID 21345815
  • Guo N, Wu F, Wu M, Wang Y, Lang Q, Lin X, Feng Y. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine. J Integr Med. 2022 May;20(3):204-212. doi: 10.1016/j.joim.2022.02.005. Epub 2022 Feb 21. PMID 35248517
  • Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000 Aug 19-26;321(7259):504. doi: 10.1136/bmj.321.7259.504. No abstract available. PMID 10948038
  • Brito-Zeron P, Theander E, Baldini C, Seror R, Retamozo S, Quartuccio L, Bootsma H, Bowman SJ, Dorner T, Gottenberg JE, Mariette X, Bombardieri S, de Vita S, Mandl T, Ng WF, Kruize AA, Tzioufas A, Vitali C, Buyon J, Izmirly P, Fox R, Ramos-Casals M; Eular Sjogren Syndrome Task Force. Early diagnosis of primary Sjogren's syndrome: EULAR-SS task force clinical recommendations. Expert Rev Clin Immuno PMID 26691952
  • Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thab PMID 40294953
  • Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O'Brien EC, Ibarra JC, Curtis LH, Peterson ED. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016 Mar 1;133(9):872-80. doi: 10.1161/CIRCULATIONAHA.115.019902. PMID 26927005
  • 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
  • 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

Identifiers

NCT: NCT07145060 · 2024-QNQS-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗