Stigma and Efficacy of Zhizhu Kuanzhong Capsules

NCT05107999 | Unknown DMC

• 1 other identifier: RJYYTCM
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders; Dyspepsia; Psychosomatic Disorder

Outcome Measures

Primary Outcomes (3)

• Changes of Leeds Dyspepsia Questionnaire (LDQ) scores at 4 weeks from baseline were obtained to assess the dyspepsia condition after treatment.

  The LDQ scores of 0-4 were classified as very mild dyspepsia, 5-8 as mild dyspepsia, 9-15 as moderate dyspepsia, and \>15 as severe or very severe dyspepsia.

  4 weeks

• Changes of Patient Health Questionnaire-9 (PHQ-9) scores at 4 weeks from baseline were obtained to assess the depression condition after treatment.

  The PHQ-9 scores of 0-4 were classified as none or minimal depression, 5-9 as mild, 10-14 as moderate, 15-19 as moderately severe, and ≥20 as severe depression.

  4 weeks

• Changes of Generalized Anxiety Questionnaire-7 (GAD-7) scores at 4 weeks from baseline were obtained to assess the anxiety condition after treatment.

  The GAD-7 scores of 0-4 were classified as the absence of anxiety, 5-9 as mild, 10-14 as moderate, and ≥15 as severe.

  4 weeks

Secondary Outcomes (2)

• Changes of Internalized stigma scale (ISS) scores at 4 weeks from baseline were obtained to assess the internalized stigma of patients after treatment.

  4 weeks

• Changes of Perceived stigma scale (PSS) scores at 4 weeks from baseline were obtained to assess the perceived stigma of patients after treatment.

  4 weeks

Study Arms (2)

Zhizhu Kuanzhong（ZZKZ） group

EXPERIMENTAL

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.

Drug: Zhizhu Kuanzhong capsules (ZZKZ)

Doxepin group

ACTIVE COMPARATOR

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.

Drug: Doxepin Hydrochloride (Doxepin)

Interventions

Zhizhu Kuanzhong capsules (ZZKZ) DRUG

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

Also known as: Traditional Chinese medicine

Zhizhu Kuanzhong（ZZKZ） group

Doxepin Hydrochloride (Doxepin) DRUG

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

Also known as: Neuromodulators, Antidepressants

Doxepin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 30207000 RESULT

• 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.

  PMID: 33258198 RESULT

• 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.

  PMID: 33184967 RESULT

• 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.

  PMID: 33484225 RESULT

• 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.

  PMID: 24674944 RESULT

• 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.

  PMID: 33049221 RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases; Dyspepsia; Psychophysiologic Disorders

Interventions

Medicine, Chinese Traditional; Doxepin; Neurotransmitter Agents; Antidepressive Agents

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics; Oxepins; Ethers, Cyclic; Ethers; Organic Chemicals; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Sheng-Liang Chen, PhD

  Division of Gastroenterology and Hepatology, Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Liang Chen, PhD

CONTACT

021-53882113; chenshengliang011774@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, chief physician

Model Details: Zhizhu Kuanzhong (ZZKZ) group was treated with ZZKZ capsules with omeprazole. Antidepressant group was treated with doxepin with omeprazole.

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: November 4, 2021
• Study Start: February 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)