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

NCT04398888 | Completed

• 1 other identifier: UW 20-216
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Distress Syndrome

Keywords

Chinese medicine; Postprandial distress syndrome; Wei Pi; Banxia Xiexin Decoction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Hospital Anxiety and Depression Scale

  Weeks 0, 3, and 7

• EQ-5D-5L

  Weeks 0, 1, 2, 3, 4, and 7

• Liver function test

  Weeks 0 and 3.

• Kidney function test

  Weeks 0 and 3.

• Quality of Life Questionnaire for Functional Digestive Disorders

  Weeks 0, 3, and 7

Study Arms (2)

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.

Other: Banxie Xiexin Decoction (BXD)

Waitlist

NO INTERVENTION

Participants in the waiting list control group will be observed for a three-week waiting period. Rescue medication is not restricted.

Interventions

Banxie Xiexin Decoction (BXD) OTHER

A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.

BXD treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Buddhist Association: collaborator

Study Sites (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

Location

Related Publications (1)

• 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.

  PMID: 33579349 DERIVED

Study Officials

• Haiyong CHEN, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: August 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 29, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)