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

NCT04380233 | Unknown DMC

• 1 other identifier: HKBU-FD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Score (VAS)

  Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early fullness, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "and 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made on the diary card once a day and 7 days a week. The integral average for the sum of VAS for both two symptoms over the past week is evaluated based on the diary card content, and a 50% decrease from baseline in the integral average at 8 weeks is recorded as a response. The proportion of the response at 8 weeks after randomization is considered primary efficacy endpoint.

  For 8 weeks

Secondary Outcomes (4)

• Evaluation of individual symptoms of Functional Dyspepsia

  For 8 weeks

• Overall Treatment Evaluation scale (OTE)

  For 8 weeks

• Hospital Anxiety and Depression Scale (HAD) score

  At baseline, week 4 and week 8

• Short Form-Nepean Dyspepsia Index (SFNDI)

  At baseline, week 4 and week 8

Study Arms (2)

Investigational Drug Group

EXPERIMENTAL

A 8-weeks double-blind treatment period with a Proprietary Chinese Medicine (consists of 4 kinds of Chinese herbs at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals

Drug: Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome

Placebo Group

PLACEBO COMPARATOR

A 8-weeks double-blind treatment period with Placebo Capsules (at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals

Drug: Placebo capsules

Interventions

Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome DRUG

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.

Also known as: Zhizhu Kuanzhong Capsule

Investigational Drug Group

Placebo capsules DRUG

The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.

Also known as: Study drug

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome;
• At least 3 days during the one-week run-in period with VAS score ≥ 4 for major symptoms (at least one of postprandial fullness discomfort and early satiety) .
• Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness.
• Written informed consent.

You may not qualify if:

• Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.
• History of abdominal surgery (except for appendectomy and cesarean section);
• Immune system defects, or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months.
• With combined severe cardiac and pulmonary insufficiency, insufficiency of liver (ALT/AST \> 1.5 times the upper limit of the normal value), kidney insufficiency (BUN/SCr \> the upper limit of the normal value), abnormal of endocrine system, abnormal hematopoietic system, and iron deficiency anemia as indicated on hematological examination.
• With severe anxiety and depression.
• With psychosis and mental retardation, language disorder precluding the ability of filling scales or recording symptoms.
• Pregnancy or lactating; or patients of childbearing potential without effective contraception.
• known to be allergic to the ingredients of this drug.
• suspected or confirmed history of alcohol or drug abuse.
• have participated in a clinical trial in the past 3 months.
• deemed by the investigator as being not suitable for participation in the clinical trial.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Interventions

Drugs, Investigational; Drug Evaluation

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Zhaoxiang Bian, MD., Ph.D

  Hong Kong Chinese Medicine Clinical Study Centre

  STUDY DIRECTOR

Central Study Contacts

Linda Zhong, MD., Ph.D

CONTACT

852-34116523; ldzhong0305@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The eligible subjects will be randomly assigned, with equal access to either the Chinese medicine treatment investigational drug group (Zhizhu Kuanzhong Capsule) or the placebo group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: April 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

HK (1)