NCT05107999

Stigma and Efficacy of Zhizhu Kuanzhong Capsules

Stigma and Efficacy of Zhizhu Kuanzhong Capsules Versus Doxepin in the Treatment of Refractory Functional Dyspepsia: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with dyspepsia have poor quality of life and emotional distress. The pathophysiology of FD is complex and multifactorial, including factors related to central nervous system and peripheral sensory system. Abundant drugs have been trialed to treat FD patients, but the treatment options remain limited and far from optimal. Antidepressants were beneficial in the treatment of FD. But the antidepressant prescriptions often aggravate the stigma of patients with FD, hinder doctor-patient communication, and reduce treatment compliance. Some patients with strong stigmatized feelings towards antidepressants refused to take the medications, and stigma related with antidepressants could ultimately affect the efficacy of FD. Zhizhu Kuanzhong capsules (ZZKZ), a commonly used traditional Chinese medicine (TCM) formula, had shown effectiveness in relieving dyspeptic symptoms. It has a long culture and history in promoting the function of brain and GI tract in whole, which is widely accepted by populations who were familiar with TCM. The study was designed to observe whether ZZKZ could alleviate stigma of patients and obtain identical effects in patients with FD, therefore provide a new insight in the treatment of FD.

Conditions

• Functional Gastrointestinal Disorders
• Dyspepsia
• Psychosomatic Disorder

Interventions

Type	Name	Description
DRUG	Zhizhu Kuanzhong capsules (ZZKZ)	FD patients were treated with ZZKZ and omeprazole for 4 weeks.
DRUG	Doxepin Hydrochloride (Doxepin)	FD patients were treated with doxepin and omeprazole for 4 weeks.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2021-11-04
• Last updated: 2022-08-10

Locations

1 site across 1 country: China