Status:
UNKNOWN
Zhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome
Lead Sponsor:
Hong Kong Baptist University
Collaborating Sponsors:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 dysp...
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 Distr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04380233
Start Date
April 1 2021
End Date
March 30 2022
Last Update
March 4 2022
Active Locations (1)
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1
Linda Zhong
Kowloon Tong, Kowloon, Hong Kong