Clinical trial NCT04398888: Efficacy of a Modified Banxia Xiexin Decoction for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome)
Official title: Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Distress Syndrome
Keywords: Chinese medicine
Postprandial distress syndrome
Wei Pi
Banxia Xiexin Decoction
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Buddhist Association
First posted: 2020-05-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy of a modified Banxia Xiexin Decoction (BXD) for Wei-Pi through a randomized, waitlist controlled trial.

Detailed description: After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized, in a 1:1 ratio, into BXD group and waitlist group.

Eligibility criteria: Inclusion Criteria:

* Permanent resident of Hong Kong with age from 18 to 60
* Have a diagnosis of Wei-Pi (postprandial distress syndrome, ie. at least one of bothersome postprandial fullness (ie, severe enough to impact on usual activities) and bothersome early satiation (ie, severe enough to prevent finishing a regular-size meal) at least three days per week for the last three months, with symptom onset at least six months before diagnosis

Exclusion Criteria:

* Pregnancy or pregnancy planners
* Abnormal liver function (up to twofold the upper normal reference level of ALT)\[14\] or kidney function (estimated creatinine clearance \< 80 mL/min)\[15\]
* History of diagnosed gastric structural abnormalities through endoscopy /History of gastric removal surgery
* Have G6PD deficiency
* Alcohol or drug abuser
* Taking Chinese medicine within one month
* Unable to read/understand and sign the informed consent document

Primary outcomes:
measure: Change of the Quality of Life Questionnaire for Functional Digestive Disorders
timeFrame: Change from baseline score at 3 weeks.
Secondary outcomes:
measure: The Hospital Anxiety and Depression Scale
timeFrame: Weeks 0, 3, and 7
measure: EQ-5D-5L
timeFrame: Weeks 0, 1, 2, 3, 4, and 7
measure: Liver function test
timeFrame: Weeks 0 and 3.
measure: Kidney function test
timeFrame: Weeks 0 and 3.
measure: Quality of Life Questionnaire for Functional Digestive Disorders
timeFrame: Weeks 0, 3, and 7
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District)
Study officials:
affiliation: The University of Hong Kong
name: Haiyong CHEN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sin SH, Wu J, Kang Y, Yip KHK, Kong NS, Wan H, Ng BFL, Chen H. Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial. Trials. 2021 Feb 12;22(1):135. doi: 10.1186/s13063-021-05078-y.