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Completed

NCT Number: NCT04398888

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Banxie Xiexin Decoction (BXD)

Other

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

Primary outcomes

  1. Change of the Quality of Life Questionnaire for Functional Digestive Disorders

    Time frame: Change from baseline score at 3 weeks.

    Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)

Secondary outcomes

  1. The Hospital Anxiety and Depression Scale

    Time frame: 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.

  2. EQ-5D-5L

    Time frame: Weeks 0, 1, 2, 3, 4, and 7

    EuroQoL 5-dimension 5-level

  3. Liver function test

    Time frame: Weeks 0 and 3.

    Serum Alanine transaminase (ALT) and Aspartate transaminase (AST).

  4. Kidney function test

    Time frame: Weeks 0 and 3.

    Estimated Glomerular Filtration Rate (eGFR)

  5. Quality of Life Questionnaire for Functional Digestive Disorders

    Time frame: Weeks 0, 3, and 7

    Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hong Kong Buddhist Association

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2020
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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