Efficacy of a Modified Banxia Xiexin Decoction for the Wei-Pi Syndrome (Postprandial Distress Syndrome)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the Wei-Pi Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial

Conditions
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Postprandial Distress Syndrome

Intervention / Treatment
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* Other: Banxie Xiexin Decoction (BXD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BXD treatment<br>Participants will be diagnosed and treated by Chinese medicine practitioners (CMPs) with at least 5 years of clinical experience. CMPs will differentiate syndrome and prescript herbs in a semi-standardized protocol, which consists of a base Chinese medicine decoction, Banxia Xiexin Decoction (BXD), and the additional syndrome-specific herbs. The modified decoction will be prepared in a conventional decocting method at the Chinese medicine pharmacy in the clinic (HKBA-HKU CMCTR) and will be packaged into bags by the auto-decocting machines. Participants will take the decoction twice per day, 5 days per week, for 3 weeks. | Other: Banxie Xiexin Decoction (BXD)<br>* A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.<br>|
| No Intervention: Waitlist<br>Participants in the waiting list control group will be observed for a three-week waiting period. Rescue medication is not restricted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Quality of Life Questionnaire for Functional Digestive Disorders | Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL) | Change from baseline score at 3 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (HADS) consists of 14 items. Each item is scored from 0-3. Total score ranges between 0 and 21 for either anxiety or depression. | Weeks 0, 3, and 7 | 
| EQ-5D-5L | EuroQoL 5-dimension 5-level | Weeks 0, 1, 2, 3, 4, and 7 | 
| Liver function test | Serum Alanine transaminase (ALT) and Aspartate transaminase (AST). | Weeks 0 and 3. | 
| Kidney function test | Estimated Glomerular Filtration Rate (eGFR) | Weeks 0 and 3. | 
| Quality of Life Questionnaire for Functional Digestive Disorders | Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL) | Weeks 0, 3, and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese medicine, Postprandial distress syndrome, Wei Pi, Banxia Xiexin Decoction