Stigma and Efficacy of Zhizhu Kuanzhong Capsules

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107999
• Other study ID #: RJYYTCM
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2022
• Source: RenJi Hospital
• Contact: Sheng-Liang Chen, PhD
• Phone: 021-53882113
• Email: chenshengliang011774[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Disease
• Dyspepsia
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Psychophysiologic Disorders
• Psychosomatic Disorder
• Somatoform Disorders

Intervention

Drug:
• Zhizhu Kuanzhong capsules (ZZKZ)
FD patients were treated with ZZKZ and omeprazole for 4 weeks.
• Doxepin Hydrochloride (Doxepin)
FD patients were treated with doxepin and omeprazole for 4 weeks.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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 Gast — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Changes of Internalized stigma scale (ISS) scores at 4 weeks from baseline were obtained to assess the internalized stigma of patients after treatment.	The Internalized stigma scale (ISS) is a 24-item self-report questionnaire with items ranked on a 4-point Likert scale (strongly disagree = 1 to strongly agree = 4 points). The ISS scores are calculated by summing the values for each item and dividing by the number of questions answered for each scale. Higher scores indicate higher levels of ISS. The ISS scores of 1-2 were classifies as minimal, 2-2.5 as mild, 2.5-3 as moderate, 3-4 as severe.	4 weeks
Secondary	Changes of Perceived stigma scale (PSS) scores at 4 weeks from baseline were obtained to assess the perceived stigma of patients after treatment.	The Perceived stigma scale (PSS) is a 10-item questionnaire with items ranked on a 5-point Likert scale (seldom = 1 to always = 5 points). The scores are calculated by summing the values for each item and dividing by the number of questions answered for each scale. Minimum to maximum score is 1 to 5 points. Higher scores indicate higher levels of PSS. The PSS scores of 1-2 were classifies as minimal, 2-3 as mild, 3-4 as moderate, 4-5 as severe.	4 weeks