Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 23, 2025
Open Peer Review Period: Jul 20, 2025 - Sep 14, 2025
Date Accepted: Dec 25, 2025
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Effectiveness and Safety of Kangjia Decoction Granules for the Treatment of Hashimoto's Thyroiditis: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Clinical Trial
ABSTRACT
Background:
Hashimoto's thyroiditis (HT) is a chronic inflammation of the thyroid gland mediated by autoimmune disorders, often leading to hypothyroidism and a significant reduction in a patient’s quality of life. Currently, there is a lack of effective clinical treatments for early-stage HT. Kangjia Decoction Granules (KDGs) were developed based on clinical experience and results analysis, showing promising outcomes in improving antibody levels and quality of life in patients with HT. However, there is a lack of further evaluation of the efficacy and safety of KDGs.
Objective:
This pilot study aims to further understand and validate the efficacy and safety of KDGs for treating HT through clinical research and comprehensively assess the benefits of this intervention for patients.
Methods:
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Participants meeting the HT diagnostic criteria will be randomly allocated to the intervention and control groups (n1 = n2 = 70). The intervention group will receive KDGs treatment, whereas the control group will receive a placebo treatment. All subjects will undergo treatment for 3 months. Changes in anti-thyroid peroxidase antibody (TPOAb) levels will be the primary outcome. Secondary outcomes include anti-thyroglobulin antibodies (TGAb), thyrotropin also known as thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroid hormone (T4), serum free triiodothyronine (FT3), serum free thyroxine (FT4), thyroid ultrasonography, IL-17/FOXP3, traditional Chinese medicine (TCM) syndrome efficacy scores, and quality of life scale scores. Throughout the treatment and follow-up periods, safety indicators, such as routine blood and urine tests, hepatic and renal function, electrocardiography, and major adverse reactions, will be monitored.
Results:
The research protocol and informed consent form received approval from the Clinical Research Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, on December 14, 2022 (Approval No. 2022-123). Participant recruitment commenced in June 2023. All intervention and concurrent data collection activities are scheduled for completion by October 2025, Data management is still ongoing; therefore, data analysis has not yet been performed.
Conclusions:
This study's findings will offer initial clinical evidence regarding the efficacy of the TCM compound KDGs in modulating peripheral immunity in patients with HT, decreasing autoimmune antibody levels, ameliorating TCM syndromes, and enhancing quality of life. These results will serve as a basis for future large-scale trial designs. Clinical Trial: China Clinical Trials Registry ChiCTR2300070184; https://www.chictr.org.cn/showprojEN. html?proj=189169
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