Postprandial Distress SyndromeNCT04398888
Efficacy of a Modified Banxia Xiexin Decoction for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome)
A study testing Banxie Xiexin Decoction (BXD) in people with Postprandial Distress Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postprandial Distress Syndrome
- What is being tested?
- Banxie Xiexin Decoction (BXD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Hong Kong1 site
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
Official title: Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial
The study aims to evaluate the efficacy of a modified Banxia Xiexin Decoction (BXD) for Wei-Pi through a randomized, waitlist controlled trial.
Read the detailed 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.
- Conditions
- Postprandial Distress Syndrome
- Being tested
- Banxie Xiexin Decoction (BXD)
- Keywords
- Chinese medicine, Postprandial distress syndrome, Wei Pi, Banxia Xiexin Decoction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banxie Xiexin Decoction (BXD)Other
A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Quality of Life Questionnaire for Functional Digestive Disorders
Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)
Measured: Change from baseline score at 3 weeks.
Secondary outcomes (5)
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.
Measured: Weeks 0, 3, and 7
EQ-5D-5L
EuroQoL 5-dimension 5-level
Measured: Weeks 0, 1, 2, 3, 4, and 7
Liver function test
Serum Alanine transaminase (ALT) and Aspartate transaminase (AST).
Measured: Weeks 0 and 3.
Kidney function test
Estimated Glomerular Filtration Rate (eGFR)
Measured: Weeks 0 and 3.
Quality of Life Questionnaire for Functional Digestive Disorders
Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)
Measured: Weeks 0, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Aug 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial Distress SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Buddhist Association
- Responsible party
- Sponsor
- Investigators
- Haiyong CHEN, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398888
- Sponsor's protocol ID
- UW 20-216
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33579349
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT04398888
- Acronym / sponsor ID
- UW 20-216
- Conditions
- Postprandial Distress Syndrome
- Keywords
- Chinese medicine, Postprandial distress syndrome, Wei Pi, Banxia Xiexin Decoction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Buddhist Association
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the efficacy of a modified Banxia Xiexin Decoction (BXD) for Wei-Pi through a randomized, waitlist controlled trial.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BXD treatment | Experimental | Other: Banxie Xiexin Decoction (BXD)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banxie Xiexin Decoction (BXD)A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation. | Other | BXD treatment |
Primary outcome
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)
5 secondary outcomes
The Hospital Anxiety and Depression Scale
Time frame: Weeks 0, 3, and 7
EQ-5D-5L
Time frame: Weeks 0, 1, 2, 3, 4, and 7
Liver function test
Time frame: Weeks 0 and 3.
Kidney function test
Time frame: Weeks 0 and 3.
Quality of Life Questionnaire for Functional Digestive Disorders
Time frame: Weeks 0, 3, and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 33579349Sin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyong CHEN, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banxie Xiexin Decoction (BXD) in people with Postprandial Distress Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Quality of Life Questionnaire for Functional Digestive Disorders (time frame: Change from baseline score at 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.