Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients

• Status: Unknown status
• Trial end date: 2021-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Criteria

Inclusion Criteria:

• Patients diagnosed with FD according to the ROME Ⅳ criteria，and must with symptom of bothersome postprandial fullness;

• Patients diagnosed with Stagnation of Qi according to traditional Chinese medicine;

• At least the symptom of bothersome postprandial fullness ≥4 on the Visual Analogue Scale(VAS), and the number of recurrence day must ≥3 in one week;

• Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.

Exclusion Criteria:

• The patients with high placebo effect, the scores in placebo run-in stage declined much than 30 percent of the mean VAS per week compare to blank run-in stage;

• Unable to take drugs orally;

• Within 7 days of Screening, the average number of stool > 2 times/day;

• Within 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale;

• History of drug or aurantium allergy;

• Patients with positive in fecal occult blood test;

• Abnormal liver and/or kidney function: creatinine >1.5*ULN (upper limits of normal), and/or AST and/or ALT > 2.0*ULN, and/or TBil > 1.5*ULN;

• Patients with family history of prolonged QT syndrome or have history of torsional apical ventricular tachycardia; or QTc > 480 ms;

• Digestive diseases, or other diseases within 6 months before Screening that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator;

• Patients who positive in H. Pylori test plan to accept the H. pylori eradication therapy within the trial;

• Serious complications (heart, brain, lung, liver, kidney, or blood disease);

• Neuropsychiatric disorders;

• Use of prohibited medications;

• Pregnant or lactating women or those who are planning to conceive during the study period;

• Drug abuse within 3 months, or alcohol abuse within 6 months;

• Patients participated in other clinical trials within 30 days before taking drugs;

• Other conditions deemed ineligible for enrollment by Investigator.