Chronic ConstipationPhase 3NCT00746200
Acupuncture for Chronic Constipation
A Phase 3 study testing (electro)acupuncture in people with Chronic Constipation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- (electro)acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2008to May 2010
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men or non-pregnant women who are at least 20 years old
- who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months
Who cannot join
- known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction
- unknown cause of gastrointestinal bleeding or acute infection
- history of alcohol or drug abuser
- women who are pregnant, as determined by a urine pregnancy test
- history of adverse reaction to (electro)acupuncture
- received herb or acupuncture therapy within one month prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation
Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.
Read the detailed description
Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem.
Since there is unsatisfactory effect by current pharmacologic therapies and preventive strategies, we look forward to the practice of traditional Chinese medicine, which had abundant clinical experiences and medical records in the past of thousands years ago. Therefore we aim to do the research to create the evidence of acupuncture on the safety, efficacy and quality of life for chronic constipation.
- Conditions
- Chronic Constipation
- Being tested
- (electro)acupuncture, sham acupuncture
- Keywords
- chronic constipation, electroacupuncture, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(electro)acupunctureProcedure or surgery
Also called electroacupuncture
Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
sham acupunctureProcedure or surgery
Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: (electro)acupuncture |
| S | Sham comparator | Not described Receives: Procedure: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of questionnaire of constipation symptoms
Measured: every month
Secondary outcomes (8)
score of questionnaire of quality of life
Measured: every month
amount of laxative use
Measured: every week
frequency of enema/suppository use/digital maneuver
Measured: every week
stool amount
Measured: every week
stool consistency
Measured: every week
overall efficacy
Measured: 2 month
safety (adverse event)
Measured: every week
frequency of spontaneous bowel movement
Measured: every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionMay 2010
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 Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chien-Hsun Huang, MD, MSc, Principal investigator, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746200
- Sponsor's protocol ID
- 200801047R
- Status last verified
- May 2010
- First submitted
- 31 Aug 2008
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.
PubMed 14523145
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00746200
- Acronym / sponsor ID
- 200801047R
- Conditions
- Chronic Constipation
- Keywords
- chronic constipation, electroacupuncture, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Sep 2008 (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.
Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.
Detailed description
Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem.
Since there is unsatisfactory effect by current pharmacologic therapies and preventive strategies, we look forward to the practice of traditional Chinese medicine, which had abundant clinical experiences and medical records in the past of thousands years ago. Therefore we aim to do the research to create the evidence of acupuncture on the safety, efficacy and quality of life for chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: (electro)acupuncture |
| S | Sham comparator | Procedure: sham acupuncture |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men or non-pregnant women who are at least 20 years old
- who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months
Key exclusion criteria (6 listed)
- known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction
- unknown cause of gastrointestinal bleeding or acute infection
- history of alcohol or drug abuser
- women who are pregnant, as determined by a urine pregnancy test
- history of adverse reaction to (electro)acupuncture
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 |
|---|---|---|
| (electro)acupunctureAlso: electroacupunctureFrequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min; | Procedure or surgery | A |
| sham acupunctureSuperficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds | Procedure or surgery | S |
Primary outcome
score of questionnaire of constipation symptoms
Time frame: every month
8 secondary outcomes
score of questionnaire of quality of life
Time frame: every month
amount of laxative use
Time frame: every week
frequency of enema/suppository use/digital maneuver
Time frame: every week
stool amount
Time frame: every week
stool consistency
Time frame: every week
overall efficacy
Time frame: 2 month
safety (adverse event)
Time frame: every week
frequency of spontaneous bowel movement
Time frame: every week
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 12 May 2010.
- Background: PubMed 14523145Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.
Related trials for Chronic Constipation
RecruitingPhase 2
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)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
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.
Chien-Hsun Huang, MD, MSc principal investigator
National Taiwan University Hospital, Yun-Lin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (electro)acupuncture in people with Chronic Constipation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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 12 May 2010. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
score of questionnaire of constipation symptoms (time frame: every month). 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 NCT00746200, 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 12 May 2010.