STUDY PROTOCOL article
Front. Med.
Sec. Rheumatology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1623474
Formulation A in the Prevention of Rheumatoid Arthritis: A Study Protocol for a Multicenter Randomized Controlled Trial
Provisionally accepted
Kaixin Gao1
Yu Wen2
Yihang Yu2
Jianhong Peng3
Weidong Liang3
Zhengdong Shen4
Lei Zhang4
Chu Yong Liang4
Liyan Mei1Haifang Du1
Xiumin Chen1,5,6,7
Maojie Wang1,5,7,8
Zehuai Wen1*
Katerina Chatzidionysiou9
Per-Johan Jakobsson9*
Runyue Huang1,5,6,7*- 1Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
- 2Guangzhou University of Chinese Medicine, Guangzhou, China
- 3Dongguan Hospital of Traditional Chinese Medicine, Dongguan, China
- 4Guangdong Provincial Hospital of Chinese Medicine Zhuhai, Zhuhai, China
- 5Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China
- 6Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guanghzou, China
- 7Guangdong Provincial Key Laboratory of Chinese Medicine for Prevention and Treatment of Refractory Chronic Diseases, Guangzhou, China
- 8Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guangzhou, China
- 9Karolinska Institutet, Stockholm, Sweden
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Background: Interventions to delay or prevent the onset of rheumatoid arthritis (RA) have attracted much attention in recent years. Researchers are now exploring various prevention strategies but no unified consensus was reached. A traditional Chinese medicine (TCM) prescription, Formulation A (FA), may be potential to reduce the risk of RA development. Methods: This is a multicenter, double-blind, placebo-controlled, randomized clinical trial. We will enroll 72 participants who are positive for anti-cyclic citrullinated peptide (anti-CCP) antibody but without synovitis. Participants will be randomly assigned to either FA or placebo for 52 weeks. All will then undergo 52 weeks of observation. The primary outcome is the time interval between the study entry and RA diagnosis. The secondary outcomes include the proportions of RA diagnosis, anti-CCP antibody, rheumatoid factor (RF), the high-sensitivity C-reactive protein (hs-CRP), the This is a provisional file, not the final typeset article erythrocyte sedimentation rate (ESR), the 28-tender joint count (TJC28), the 28-swollen joint count (SJC28), morning stiffness time, the visual analog scale (VAS), Patient's Global Assessment (PtGA), Physician's Global Assessment (PGA), Health Assessment Questionnaire (HAQ), Generic Quality of Life Inventory-74 (GQOLI-74) scores, and ultrasound images of joints. Discussion: This study attempts to test the feasibility of a clinical trial using FA in RA prevention. It will lay the foundation for future research and ensure validity. Trial registration: The trial was registered in the Chinese Clinical Trial Registry on October 1, 2021. Registration number: ChiCTR2100051741. URL: http://www.chictr.org.cn/showproj.aspx?proj=133579
Keywords: Rheumatoid arthritis, prevention, Traditional Chinese Medicine, formulation A, randomized controlled trial, protocol
Received: 06 May 2025; Accepted: 01 Sep 2025.
Copyright: © 2025 Gao, Wen, Yu, Peng, Liang, Shen, Zhang, Liang, Mei, Du, Chen, Wang, Wen, Chatzidionysiou, Jakobsson and Huang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Zehuai Wen, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
Per-Johan Jakobsson, Karolinska Institutet, Stockholm, Sweden
Runyue Huang, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
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