Zhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome
NCT ID: NCT04380233
Last Updated: 2022-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-04-01
2022-03-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Investigational Drug Group
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
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.
Placebo Group
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
Placebo capsules
The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.
Interventions
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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.
Placebo capsules
The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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) .
3. Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness.
4. Written informed consent.
Exclusion Criteria
2. History of abdominal surgery (except for appendectomy and cesarean section);
3. Immune system defects, or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months.
4. 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.
5. With severe anxiety and depression.
6. With psychosis and mental retardation, language disorder precluding the ability of filling scales or recording symptoms.
7. Pregnancy or lactating; or patients of childbearing potential without effective contraception.
8. known to be allergic to the ingredients of this drug.
9. suspected or confirmed history of alcohol or drug abuse.
10. have participated in a clinical trial in the past 3 months.
11. deemed by the investigator as being not suitable for participation in the clinical trial.
18 Years
65 Years
ALL
No
Sponsors
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Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Hong Kong Baptist University
OTHER
Responsible Party
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Zhong Lidan
Assistant Professor
Principal Investigators
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Zhaoxiang Bian, MD., Ph.D
Role: STUDY_DIRECTOR
Hong Kong Chinese Medicine Clinical Study Centre
Locations
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Linda Zhong
Kowloon Tong, Kowloon, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HKBU-FD
Identifier Type: -
Identifier Source: org_study_id
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