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
This is a multi-center, randomized, double blind, placebo-controlled phase Ⅱc study to evaluate the safety and validity of Aolanti Weipang Tablets in patients with postprandial discomfort syndrome of Functional Dyspepsia(FD). This study will consecutive about 12 weeks, including 2 weeks of screening, 1 week of blank run-in, 1 week of placebo run-in, 4 weeks of double blind treatment and 4 weeks of observation after treatment. The subjects will be randomly given orally Aolanti Weikang Tablets or placebo tablets at a 1:1 ratio three times a day(tid) with 3 tablets one time for the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
236
3 tablets one time, 3 times a day(tid)
3 tablets one time, 3 times a day(tid)
The Second People's Hospital of Fujian Province
Fuzhou, Fujian, China
The response rate of patient's on the syndrome of postprandial discomfort
the response rate of patients on the syndrome of postprandial discomfort, patient's evaluation of symptomatic improvement by overall treatment efficacy is classified by 7 point Likert scale: Significantly improved Improved Slightly improved No change Slightly worse Worse Much worse And only the Improved and Significantly improved classified as responsed.
Time frame: 4 weeks
The response rate of patient's on the syndrome of postprandial discomfort and early satiation
the response rate of patient's on the syndrome of postprandial discomfort and early satiation
Time frame: 8 weeks
The response rate of patient's on the syndrome of early satiation
the response rate of patient's on the syndrome of early satiation
Time frame: 8 weeks
The safety of Aolanti Weikang Tablets on patients
Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE
Time frame: 8 weeks
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