drugset / Trial / NCT05107999
Stigma and Efficacy of Zhizhu Kuanzhong Capsules
RandomizedParallel-groupOpen-labelTreatment
Summary
Antidepressants are effective in patients with functional dyspepsia (FD), however, the stigma related with FD and antidepressants could affect treatment adherence and efficacy. Zhi Zhu Kuan Zhong capsules (ZZKZ), a traditional Chinese medicine fomula, showed therapeutic potential for FD. The study was designed to investigate whether ZZKZ could alleviate stigma in FD and obtain identical effects in patients with refractory FD.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2022-08-01
- Completion
- 2022-09-01
Publications
- Results Xiao Y, Li Y, Shu J, Li Y, Xu J, Ren J, Liu D, Wang J, Zhou L, Li Y, Tang G, Tian D, Zhang S, Hou X, Wang H, Li Z, Lv N, Chen M. The efficacy of oral Zhizhu Kuanzhong, a traditional Chinese medicine, in patients with postprandial distress syndrome. J Gastroenterol Hepatol. 2019 Mar;34(3):526-531. doi: 10.1111/jgh.14467. Epub 2018 Oct 12.
- Results Gwee KA, Holtmann G, Tack J, Suzuki H, Liu J, Xiao Y, Chen MH, Hou X, Wu DC, Toh C, Lu F, Tang XD. Herbal medicines in functional dyspepsia-Untapped opportunities not without risks. Neurogastroenterol Motil. 2021 Feb;33(2):e14044. doi: 10.1111/nmo.14044. Epub 2020 Nov 30.
- Results Yan XJ, Luo QQ, Qiu HY, Ji CF, Chen SL. The impact of stigma on medication adherence in patients with functional dyspepsia. Neurogastroenterol Motil. 2021 Feb;33(2):e13956. doi: 10.1111/nmo.13956. Epub 2020 Jul 27.
- Results Feingold JH, Drossman DA. Deconstructing stigma as a barrier to treating DGBI: Lessons for clinicians. Neurogastroenterol Motil. 2021 Feb;33(2):e14080. doi: 10.1111/nmo.14080. Epub 2021 Jan 23.
- Results Holtmann G, Talley NJ. Herbal medicines for the treatment of functional and inflammatory bowel disorders. Clin Gastroenterol Hepatol. 2015 Mar;13(3):422-32. doi: 10.1016/j.cgh.2014.03.014. Epub 2014 Mar 25.
- Results Black CJ, Drossman DA, Talley NJ, Ruddy J, Ford AC. Functional gastrointestinal disorders: advances in understanding and management. Lancet. 2020 Nov 21;396(10263):1664-1674. doi: 10.1016/S0140-6736(20)32115-2. Epub 2020 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxepin | Unknown | 25 mg | — |
| Subject | Zhizhu Kuanzhong | Traditional medicine (herbal / TCM) | 2 unknown | Oral |