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

Postprandial Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398888
• Other study ID #: UW 20-216
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Postprandial Distress Syndrome
• Syndrome

Intervention

Other:
• Banxie Xiexin Decoction (BXD)
A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District)	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Buddhist Association

Country where clinical trial is conducted

Hong Kong, 

Outcome

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