NCT04380233

Zhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Research of Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia-Postprandial Distress Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A 13 weeks randomized, double-blind and placebo parallel-controlled trial will be conducted to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treatment of functional dyspepsia-postprandial distress syndrome.

Detailed description

This is a multi-center, randomized, double-blind, placebo parallel-controlled International clinical trial of Zhizhu Kuanzhong Capsule in treating patients with Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS). In this study, Hong Kong Baptist University will collaborate with Xiyuan Hospital of China Academy of Chinese Medical Sciences, and will be recruiting 60 FD-PDS patients as study subjects in Hong Kong, out of the total sample size of 480 patients. The study includes a 1 week run-in period, 8 weeks double-blind treatment period and a 4 weeks of follow up period for each eligible subject. Eligible subjects will be randomly assigned to either the trial drug or the placebo. 6 follow-up visits and 1 telephone follow-up will be scheduled for each subject on the -7 days (visit 1), enrollment on day 0 (visit 2), 14th day (visit 3), 28th day (visit 4), 42nd day (visit 5, telephone follow-up), the 56th day (visit 6) and the 84th day (visit 7) respectively. Urine, stool and blood samples will be collected from each subject on visit 2 and visit 6 for blood, urine, stool, liver and kidney function tests.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome	The investigational drug is a new pure type of gastrointestinal function modulator traditional Chinese medicine, composed of 4 kinds of Chinese herbs: Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Radix Bupleuri and Fructus Crataegi. The preliminary clinical trial showed that it has a good therapeutic effect on FD patients, its Fructus Aurantii Immaturus promotes gastric emptying by stimulating the cells to release motilin, thereby significantly improving patients' symptoms of fullness, epigastric pain, eructation, and nausea and vomiting.
DRUG	Placebo capsules	The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-02-28
• Completion: 2022-03-30
• First posted: 2020-05-08
• Last updated: 2022-03-04

Locations

1 site across 1 country: Hong Kong