Trial | NCT04398888  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    88
The study aims to evaluate the efficacy of a modified Banxia Xiexin Decoction (BXD) for Wei-Pi through a randomized, waitlist controlled trial.
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 Started
Aug 01
2020
Primary Completion
Sep 30
2021
Study Completion
Sep 30
2021
Last Update
Jul 29
2022

Other Banxie Xiexin Decoction (BXD)

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

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.

Waitlist No Intervention

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

Criteria 

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
No Results Posted