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Набор скоро начнётся NCT07145060

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

Без фазы С лечением Primary Sjögren's Syndrome (pSS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Yiqi Yangyin Formula, Yiqi Yangyin Formula placebo.
Кому может быть актуально
Состояния в реестре: Primary Sjögren's Syndrome (pSS). Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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)
  • Препарат 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • China-Japan friendship hospital — Пекин

Публикации

  • 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

Идентификаторы

NCT: NCT07145060 · 2024-QNQS-07

Первоисточники (государственные реестры)

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