Stigma and Efficacy of Zhizhu Kuanzhong Capsules (NCT05107999) | Clinical Trial Compass
UnknownNot Applicable
Stigma and Efficacy of Zhizhu Kuanzhong Capsules
China76 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of Leeds Dyspepsia Questionnaire (LDQ) scores at 4 weeks from baseline were obtained to assess the dyspepsia condition after treatment.
Timeframe: 4 weeks
2
Changes of Patient Health Questionnaire-9 (PHQ-9) scores at 4 weeks from baseline were obtained to assess the depression condition after treatment.
Timeframe: 4 weeks
3
Changes of Generalized Anxiety Questionnaire-7 (GAD-7) scores at 4 weeks from baseline were obtained to assess the anxiety condition after treatment.