ConstipationPhase 2NCT02795390
Clinical Trial on Palliative Cancer Patients With Constipation
A Phase 2 study testing Chinese herbal medicine in people with Constipation, run by Hong Kong Baptist University at 3 sites in Hong Kong.
Trial summary
It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Chinese herbal medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesHong Kong
- Study dates
- Nov 2016to Aug 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severity of constipation > 3 points (an 8-point scale from 0 to 7)
- Palliative Performance Scale ≥60%
- Relatively stable liver and renal function within 3 months
- Patients who can read and speak Chinese
Who cannot join
- Inability to communicate
- Presence of a colostomy, or gastrointestinal obstruction
- Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement > 3/day under routine laxative treatment
- History of Chinese herbal medicine allergies
- Estimated life expectancy less than 1 month
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Caritas Medical Centre
Hong Kong
Hong Kong Buddhist Hospital
Hong Kong
Our Lady of Maryknoll Hospital
Hong Kong
About this study
Official title: Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation
It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.
- Conditions
- Constipation
- Being tested
- Chinese herbal medicine, Placebo
- Keywords
- Chinese herbal medicine formula, MaZiRenWan, Randomized controlled trial, Constipation, Palliative care in cancer
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicine | Experimental | MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang. Receives: Drug: Chinese herbal medicine |
| Placebo | Placebo comparator | Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global symptom improvement (improved / same / worse)
Participants are asked to rate their impression of change in constipation symptoms in comparison with their baseline, with scores from 0 to 6 represents markedly worse or better at the respective extremes. The response categories are collapsed to simply "improved" for score 4-6, "same" for score 3, or "worse" for score 0-2.
Measured: 2 weeks
Secondary outcomes (10)
Number of bowel movement (times/day)
Measured: 2 weeks
Stool form
Stool form is assessed with 7-point Bristol Stool Scale (ranging from "separate hard lumps" to "watery")
Measured: 2 weeks
Extra laxatives used (times/week)
Measured: 2 week
Constipation visual analogue scale
The severity of constipation is evaluated by an eight point ordinal rating scale (0=none to 7=most severe)
Measured: 2 weeks
Constipation related symptoms
Sensation of straining, incomplete evacuation, bloating, abdominal pain/cramping, nausea, and passing of gas are recorded using a 7-point ordinal scale (0=not at all and 6=very severe)
Measured: 2 weeks
Adverse events
Measured: 2 weeks
Blood creatinine level (umol/L)
Measured: 2 weeks
Blood urea level (mmol/L)
Measured: 2 weeks
Serum glutamic pyruvic transaminase(SGPT) Level (U/L)
Measured: 2 weeks
Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018
- Study completionAug 2018
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 ConstipationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Caritas Medical Centre, Hong Kong, Yan Chai Hospital, Our Lady of Maryknoll Hospital, Hong Kong Buddhist Hospital, Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Zhao-xiang Bian, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795390
- Sponsor's protocol ID
- HKBU/KWC/PC2014
- Status last verified
- Aug 2018
- First submitted
- 25 May 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Research results will be published after analysis.
Publications
Cheng CW, Mok HF, Yau CWS, Chan JTM, Kang YC, Lam PY, Zhong LLD, Zhao C, Ng BFL, Kwok AOL, Tse DMW, Bian ZX. A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients. Chin Med. 2022 Mar 2;17(1):31. doi: 10.1186/s13020-022-00580-0.
PubMed 35236375
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation
- ClinicalTrials.gov ID
- NCT02795390
- Acronym / sponsor ID
- HKBU/KWC/PC2014
- Conditions
- Constipation
- Keywords
- Chinese herbal medicine formula, MaZiRenWan, Randomized controlled trial, Constipation, Palliative care in cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Caritas Medical Centre, Hong Kong, Yan Chai Hospital, Our Lady of Maryknoll Hospital, Hong Kong Buddhist Hospital, Hospital Authority, Hong Kong
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Jun 2016 (estimated)
- 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.
It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine | Experimental | Drug: Chinese herbal medicineMaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severity of constipation > 3 points (an 8-point scale from 0 to 7)
- Palliative Performance Scale ≥60%
- Relatively stable liver and renal function within 3 months
- Patients who can read and speak Chinese
Key exclusion criteria (5 listed)
- Inability to communicate
- Presence of a colostomy, or gastrointestinal obstruction
- Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement > 3/day under routine laxative treatment
- History of Chinese herbal medicine allergies
- Estimated life expectancy less than 1 month
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 |
|---|---|---|
| Chinese herbal medicine | Drug | Chinese herbal medicine |
| Placebo | Drug | Placebo |
Primary outcome
Global symptom improvement (improved / same / worse)
Time frame: 2 weeks
Participants are asked to rate their impression of change in constipation symptoms in comparison with their baseline, with scores from 0 to 6 represents markedly worse or better at the respective extremes. The response categories are collapsed to simply "improved" for score 4-6, "same" for score 3, or "worse" for score 0-2.
10 secondary outcomes
Number of bowel movement (times/day)
Time frame: 2 weeks
Stool form
Time frame: 2 weeks
Extra laxatives used (times/week)
Time frame: 2 week
Constipation visual analogue scale
Time frame: 2 weeks
Constipation related symptoms
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
Blood creatinine level (umol/L)
Time frame: 2 weeks
Blood urea level (mmol/L)
Time frame: 2 weeks
Serum glutamic pyruvic transaminase(SGPT) Level (U/L)
Time frame: 2 weeks
Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L)
Time frame: 2 weeks
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 8 Aug 2018.
- Derived from this study: PubMed 35236375Cheng CW, Mok HF, Yau CWS, Chan JTM, Kang YC, Lam PY, Zhong LLD, Zhao C, Ng BFL, Kwok AOL, Tse DMW, Bian ZX. A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients. Chin Med. 2022 Mar 2;17(1):31. doi: 10.1186/s13020-022-00580-0.
- Individual participant dataSharing planned: Yes. Research results will be published after analysis.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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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.
Zhao-xiang Bian, PhD principal investigator
Hong Kong Baptist University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese herbal medicine in people with Constipation, run by Hong Kong Baptist University at 3 sites 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 4 inclusion and 5 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Global symptom improvement (improved / same / worse) (time frame: 2 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 NCT02795390, 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 8 Aug 2018.