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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Postprandial Distress Syndrome

Treatments: Other: Banxie Xiexin Decoction (BXD)

Study type: Interventional

Funder types: Other

Identifiers

NCT04398888

UW 20-216

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

BXD treatment

Experimental group

Description:

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.

Treatment:

Other: Banxie Xiexin Decoction (BXD)

Waitlist

No Intervention group

Description:

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