Stigma and Efficacy of Zhizhu Kuanzhong Capsules

NCT ID: NCT05107999

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zhizhu Kuanzhong（ZZKZ） group

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.

Group Type: EXPERIMENTAL

Zhizhu Kuanzhong capsules (ZZKZ)

Intervention Type: DRUG

FD patients were treated with ZZKZ and omeprazole for 4 weeks.

Doxepin group

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.

Group Type: ACTIVE_COMPARATOR

Doxepin Hydrochloride (Doxepin)

Intervention Type: DRUG

FD patients were treated with doxepin and omeprazole for 4 weeks.

Interventions

Zhizhu Kuanzhong capsules (ZZKZ)

FD patients were treated with ZZKZ and omeprazole for 4 weeks.

Intervention Type: DRUG

Doxepin Hydrochloride (Doxepin)

FD patients were treated with doxepin and omeprazole for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Traditional Chinese medicine; Neuromodulators; Antidepressants

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengliang Chen

professor, chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheng-Liang Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology, Renji Hospital

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sheng-Liang Chen, PhD

Role: CONTACT

chenshengliang011774@renji.com

021-53882113

Facility Contacts

Chen, PhD

Role: primary

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 24674944 (View on PubMed)

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Reference Type: RESULT

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Other Identifiers

RJYYTCM

Identifier Type: -

Identifier Source: org_study_id