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

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

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

Study Overview

• Status: Completed
• Conditions: Postprandial Distress Syndrome
• Intervention / Treatment: Other: Banxie Xiexin Decoction (BXD)

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BXD treatment; 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); A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.
NO_INTERVENTION: Waitlist; 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?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hong Kong Buddhist Association

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Chinese medicine; Postprandial distress syndrome; Wei Pi; Banxia Xiexin Decoction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: UW 20-216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No