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

Not Applicable

Completed

• Conditions: Postprandial Distress Syndrome
• Interventions: Other: Banxie Xiexin Decoction (BXD)

• Registration Number: NCT04398888
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-21
• Study Start: 2020-08-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BXD treatment	Banxie Xiexin Decoction (BXD)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Kidney function test	Weeks 0 and 3.	Estimated Glomerular Filtration Rate (eGFR)
Liver function test	Weeks 0 and 3.	Serum Alanine transaminase (ALT) and Aspartate transaminase (AST).
Quality of Life Questionnaire for Functional Digestive Disorders	Weeks 0, 3, and 7	Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)
EQ-5D-5L	Weeks 0, 1, 2, 3, 4, and 7	EuroQoL 5-dimension 5-level

Trial Locations

Locations (1)

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