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| Name | Class |
|---|---|
| Hong Kong Buddhist Association | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BXD treatment | Experimental | 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. |
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| Waitlist | No Intervention | Participants in the waiting list control group will be observed for a three-week waiting period. Rescue medication is not restricted. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banxie Xiexin Decoction (BXD) | Other | A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation. |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haiyong CHEN, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District) | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33579349 | Derived | 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. |
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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 |