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

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.

Timeline

Start

2025-09-01

Primary completion

2028-01-31

Completion

2028-03-31

Publications

• Results 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 consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.
• Results 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.
• Results 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.
• Results 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 Immunol. 2016;12(2):137-56. doi: 10.1586/1744666X.2016.1109449. Epub 2015 Dec 22.
• Results 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, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
• Results 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.
• Results 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.
• Results 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.
• Results Bowman SJ, Everett CC, O'Dwyer JL, Emery P, Pitzalis C, Ng WF, Pease CT, Price EJ, Sutcliffe N, Gendi NST, Hall FC, Ruddock SP, Fernandez C, Reynolds C, Hulme CT, Davies KA, Edwards CJ, Lanyon PC, Moots RJ, Roussou E, Giles IP, Sharples LD, Bombardieri M. Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2017 Jul;69(7):1440-1450. doi: 10.1002/art.40093. Epub 2017 Jun 5.
• Results Ramos-Casals M, Brito-Zeron P, Bombardieri S, Bootsma H, De Vita S, Dorner T, Fisher BA, Gottenberg JE, Hernandez-Molina G, Kocher A, Kostov B, Kruize AA, Mandl T, Ng WF, Retamozo S, Seror R, Shoenfeld Y, Siso-Almirall A, Tzioufas AG, Vitali C, Bowman S, Mariette X; EULAR-Sjogren Syndrome Task Force Group. EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. doi: 10.1136/annrheumdis-2019-216114. Epub 2019 Oct 31.
• Results Brito-Zeron P, Retamozo S, Gheitasi H, Ramos-Casals M. Treating the Underlying Pathophysiology of Primary Sjogren Syndrome: Recent Advances and Future Prospects. Drugs. 2016 Nov;76(17):1601-1623. doi: 10.1007/s40265-016-0659-z.
• Results Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.

Drugs

Indications