An interventional study of Zhizhu Kuanzhong capsules (ZZKZ) and Doxepin Hydrochloride (Doxepin) in Functional Gastrointestinal Disorders, Dyspepsia and Psychosomatic Disorder, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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.
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 76 is close to the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
FD patients were treated with ZZKZ and omeprazole for 4 weeks.
Also known as: Traditional Chinese medicine
FD patients were treated with doxepin and omeprazole for 4 weeks.
Also known as: Neuromodulators, Antidepressants
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 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.
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.
Time frame: 4 weeks
Plan to share: No
Started Feb 2021 (actual). Primary completion is estimated for Aug 2022, 18 months after the start.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 18 months is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Drugs, Chinese Herbal