Stigma and Efficacy of Zhizhu Kuanzhong Capsules

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Psychosomatic Disorder; Functional Gastrointestinal Disorders; Dyspepsia

Treatments: Drug: Zhizhu Kuanzhong capsules (ZZKZ); Drug: Doxepin Hydrochloride (Doxepin)

Study type: Interventional

Funder types: Other

Identifiers

NCT05107999

RJYYTCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inclusion criteria includes:
• 18-70 years old;
• education level higher than middle school;
• met the Rome IV criteria for FD;
• absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
• absence of Helicobacter pylori infection;
• signed written informed consent for participation in the study.

Exclusion criteria

• The exclusion criteria includes:
• evidence of organic digestive diseases;
• diabetes, cancer and other diseases might affect GI function;
• pregnancy, lactation or breastfeeding;
• a history of allergic reaction to any of the drugs used in the study;
• participation in other clinical trials in the previous 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Zhizhu Kuanzhong（ZZKZ） group

Experimental group

Description:

Patients in ZZKZ group were given ZZKZ (2 capsules tid) plus omeprazole (20 mg bid). ZZKZ was applied after each meal. Omeprazole was applied twice daily, before breakfast and supper.

Treatment:

Drug: Zhizhu Kuanzhong capsules (ZZKZ)

Doxepin group

Active Comparator group

Description:

Patients in doxepin group were given doxepin (25 mg tid) plus omeprazole (20 mg bid). Doxepin was applied after each meal. Omeprazole was applied twice daily, before breakfast and supper.

Treatment:

Drug: Doxepin Hydrochloride (Doxepin)