Postprandial Distress Syndrome
Conditions
Keywords
Chinese medicine, Postprandial distress syndrome, Wei Pi, Banxia Xiexin Decoction
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.
Interventions
OTHERBanxie Xiexin Decoction (BXD)
A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.
Sponsors
Hong Kong Buddhist Association
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Quality of Life Questionnaire for Functional Digestive Disorders | Change from baseline score at 3 weeks. | Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Hospital Anxiety and Depression Scale | Weeks 0, 3, and 7 | 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. |
| EQ-5D-5L | Weeks 0, 1, 2, 3, 4, and 7 | EuroQoL 5-dimension 5-level |
| Liver function test | Weeks 0 and 3. | Serum Alanine transaminase (ALT) and Aspartate transaminase (AST). |
| Kidney function test | Weeks 0 and 3. | Estimated Glomerular Filtration Rate (eGFR) |
| Quality of Life Questionnaire for Functional Digestive Disorders | Weeks 0, 3, and 7 | Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL) |
Countries
Hong Kong
Outcome results
None listed