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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Baptist University
• Collaborator: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Criteria

Inclusion Criteria:

1. Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome;

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:

1. Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.

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.