A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Qifangfeixian Granules in the Treatment of Connective Tissue Disease-Associated Interstitial Lung Disease (CTD-ILD)

Summary

Interstitial lung disease (ILD) is a heterogeneous group of diseases characterized by inflammation and/or fibrinization of the alveolar unit due to a variety of known or unknown causes. CTD-ILD is one of its common categories and includes any ILD with a definite diagnosis of connective tissue disease or with a set of symptoms, signs, and abnormalities suggested by laboratory examination. The incidence of CTD-ILD varies from home to abroad. Foreign studies indicate that the number of CTD-ILD in this study accounted for 34.8% of the total number of ILD in this study, while domestic studies indicate that the number of CTD-ILD in this study accounted for 67% of the total number of ILD. At present, the treatment of CTD-ILD includes hormone, immunosuppressant cyclophosphamide, mortemycophenate, tacrolimus, etc. The above treatment has great side effects, which may increase the risk of infection and the incidence of malignant tumor. Traditional Chinese medicine has unique advantages in alleviating the clinical symptoms of the disease, reducing the use of hormones and hormone complications, and preventing infection. Qifangfeixian granule is derived from "Fangji Huangqi Decoction" in the Summary of Golden Chamber. Modern pharmacology shows that Huangqi has the functions of regulating immunity, protecting liver, antibacterial and antiviral, etc. In order to further evaluate the effectiveness and safety of using Qifangfeixian granule (Huangqi, Fangji, dogwood, dodder, ginkgo, salvia miltiorrhizae, Taoren, etc.) in the treatment of CTD-ILD patients, Determined to explore a path of CTD-ILD treatment with Chinese characteristics, we hereby apply for a multicenter controlled clinical study.

Timeline

Start

2024-10-25

Primary completion

2027-05-20

Completion

2027-06-01

Publications

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• Background Yang CG, Mao XL, Wu JF, An X, Cao JJ, Zhang XY, Li M, Zhang FF. Amelioration of Lung Fibrosis by Total Flavonoids of Astragalus via Inflammatory Modulation and Epithelium Regeneration. Am J Chin Med. 2023;51(2):373-389. doi: 10.1142/S0192415X23500192. Epub 2023 Jan 20.
• Background You Zaijing, Synopsis of Golden Chamber (in Chinese). Beijing: China Traditional Chinese Medicine Press, 2006:11
• Background Wilson TM, Solomon JJ, Demoruelle MK. Treatment approach to connective tissue disease-associated interstitial lung disease. Curr Opin Pharmacol. 2022 Aug;65:102245. doi: 10.1016/j.coph.2022.102245. Epub 2022 Jun 1.
• Background Li L, Zuo X, Luo H, Li Y, You Y, Duan L, Zhang W, Zhao H, Li T, Ning W, Xie Y, Liu S, Xie X, Jiang Y, Wu S, Zhu H, Zhou Y. Mortality trend of inpatients with connective tissue diseases: 2005-2014. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2017 Aug 28;42(8):927-933. doi: 10.11817/j.issn.1672-7347.2017.08.009.
• Background Spagnolo P, Distler O, Ryerson CJ, Tzouvelekis A, Lee JS, Bonella F, Bouros D, Hoffmann-Vold AM, Crestani B, Matteson EL. Mechanisms of progressive fibrosis in connective tissue disease (CTD)-associated interstitial lung diseases (ILDs). Ann Rheum Dis. 2021 Feb;80(2):143-150. doi: 10.1136/annrheumdis-2020-217230. Epub 2020 Oct 9.
• Background Yang Xiguang, Chen Weisong, Xu Jilin, et al. Analysis of clinical features of interstitial lung disease associated with connective tissue disease in 186 cases. Chinese Journal of General Practitioners, 2019,18 (3) : 250-250.
• Background Zou QH, Lu YW, Zhou JG, Liu XX, Li MT, Zhao Y. [Recommendations for the diagnosis and treatment of connective tissue disease-associated interstitial lung disease in China]. Zhonghua Nei Ke Za Zhi. 2022 Nov 1;61(11):1217-1223. doi: 10.3760/cma.j.cn112138-20220525-00406. Chinese.
• Background Alhamad EH. Interstitial lung diseases in Saudi Arabia: A single-center study. Ann Thorac Med. 2013 Jan;8(1):33-7. doi: 10.4103/1817-1737.105717.
• Background Aithala R, Alex AG, Danda D. Pulmonary hypertension in connective tissue diseases: an update. Int J Rheum Dis. 2017 Jan;20(1):5-24. doi: 10.1111/1756-185X.13001. Epub 2017 Feb 16.
• Background Mathai SC, Danoff SK. Management of interstitial lung disease associated with connective tissue disease. BMJ. 2016 Feb 24;352:h6819. doi: 10.1136/bmj.h6819.
• Background Wijsenbeek M, Cottin V. Spectrum of Fibrotic Lung Diseases. N Engl J Med. 2020 Sep 3;383(10):958-968. doi: 10.1056/NEJMra2005230. No abstract available.
• Background Wijsenbeek M, Suzuki A, Maher TM. Interstitial lung diseases. Lancet. 2022 Sep 3;400(10354):769-786. doi: 10.1016/S0140-6736(22)01052-2. Epub 2022 Aug 11.

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