Journal of Oriental Neuropsychiatry (동의신경정신과학회지)

The Korean Society of Oriental Neuropsychiatry (대한한방신경정신과학회)
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Efficacy and Safety of Banhahubak-Tang for Depression Treatment: Study Protocol for a Randomized, Waitlist-Controlled Trial

  • Seung-Ho, Lee (Department of Clinical Korean Medicine, Graduate School, Kyung Hee University) ;
  • Yunna, Kim (Department of Clinical Korean Medicine, Graduate School, Kyung Hee University) ;
  • Dohyung, Kwon (Department of Clinical Korean Medicine, Graduate School, Kyung Hee University) ;
  • Seung-Hun, Cho (College of Korean Medicine, Kyung Hee University)
  • Received : 2022.11.10
  • Accepted : 2022.12.14
  • Published : 2022.12.30
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Abstract

Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

Keywords

Acknowledgement

This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HF21C0036).

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