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

NCT04380233 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

  • Functional Dyspepsia

Interventions

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.

Sponsors & Collaborators

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    collaborator OTHER

  • Hong Kong Baptist University

    lead OTHER

Principal Investigators

  • Zhaoxiang Bian, MD., Ph.D · Hong Kong Chinese Medicine Clinical Study Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-02-28
Completion
2022-03-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380233 on ClinicalTrials.gov