Traditional Chinese Medicine Alleviates Stigma in Patients With Functional Dyspepsia

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Antidepressants are effective in functional dyspepsia (FD) patients, however, the stigma related with FD and antidepressants could possibly affect treatment adherence and efficacy. Zhi Zhu Kuan Zhong capsules (ZZKZs), a kind of herbal medicine, showed therapeutic potential for FD. The study was designed to investigate whether ZZKZs could alleviate stigma in FD and obtain identical effects in patients with FD overlapping mild anxiety/depression.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Antidepressive Agents; Neurotransmitter Agents

Criteria

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;

• severe psychological symptoms with GAD-7 ≥ 15 or PHQ-9 ≥ 15 or cognitive disorders;

• 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.