Slow Transmission ConstipationPhase 2AASNCT06680882
The Effect of Non-invasive Auricular Acupoint Stimulation on Slow Transmission Constipation
A Phase 2 study testing Auricular Acupoint Stimulation +prucapride and prucapride in people with Slow Transmission Constipation, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
Trial summary
Objective To examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation. Methods In a randomized clinical trial, 60 patients diagnosed with slow transit constipation (STC), ranging in age from 40 to 75 years, were allocated into… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Slow Transmission Constipation
- What is being tested?
- Auricular Acupoint Stimulation +prucapride and prucapride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2024to 1 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: ① Conformity to the diagnostic benchmarks for STC as delineated in the Rome IV criteria; ② Absence of ingestion of any medication influencing gastrointestinal motility within the preceding three months; ③ Provision of informed consent after a comprehensive understanding of the study's objectives; ④ An age range of 40 to 75 years.
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Exclusion Criteria: ① Withdrawal from the therapeutic regimen; ② Auricle or ear canal pathologies; ③ Organic defecation disorder; ④ Pregnant or lactating.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Second Hospital Affiliated Anhui University of Chinese Medicine
Objective To examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation.
Methods In a randomized clinical trial, 60 patients diagnosed with slow transit constipation (STC), ranging in age from 40 to 75 years, were allocated into two distinct cohorts: a study group and a control group. The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride, while the control group, also consisting of 30 patients, was administered prucapride as a monotherapy. To assess the efficacy of the interventions, various parameters were monitored, including serum levels of Neuropeptide Y (NPY), nitric oxide (NO), fecal water content, and gastrointestinal (GI) transit. The comparative therapeutic outcomes were determined by calculating symptom scores.
- Conditions
- Slow Transmission Constipation
- Being tested
- Auricular Acupoint Stimulation +prucapride, prucapride
- Keywords
- slow transmission constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupoint Stimulation +prucaprideOther
The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
prucaprideDrug
was administered prucapride as a monotherapy
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride Receives: Other: Auricular Acupoint Stimulation +prucapride |
| control group | Other | also consisting of 30 patients, was administered prucapride as a monotherapy. Receives: Drug: prucapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall efficacy rate
Symptoms were assessed both one week prior to and one week following treatment. The defecation time (scored as follows: 0 for ≤5 minutes; 1 for >5 to ≤15 minutes; 2 for >15 to ≤25 minutes; and 3 for >25 minutes) and the inter defecation interval (scored as the number of hours divided by 24) were recorded. The efficacy index was calculated using the formula: [(pretreatment score - posttreatment score)/ pretreatment score] × 100%.
Measured: From enrollment to the end of treatment at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start7 Nov 2024 (estimated)
- Primary completion7 Nov 2024
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slow Transmission 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
- Model description
- slow transmission constipation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heng Deng, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680882
- Sponsor's protocol ID
- AH2022056
- Other IDs
- No. 2023AH050848
- Acronym
- AAS
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial, only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Hospital Affiliated Anhui University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT06680882
- Acronym / sponsor ID
- AAS / AH2022056
- Conditions
- Slow Transmission Constipation
- Keywords
- slow transmission constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 7 Nov 2024 (estimated)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
Objective To examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation.
Methods In a randomized clinical trial, 60 patients diagnosed with slow transit constipation (STC), ranging in age from 40 to 75 years, were allocated into two distinct cohorts: a study group and a control group. The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride, while the control group, also consisting of 30 patients, was administered prucapride as a monotherapy. To assess the efficacy of the interventions, various parameters were monitored, including serum levels of Neuropeptide Y (NPY), nitric oxide (NO), fecal water content, and gastrointestinal (GI) transit. The comparative therapeutic outcomes were determined by calculating symptom scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- slow transmission constipation
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Auricular Acupoint Stimulation +prucaprideThe study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride |
| control group | Other | Drug: prucapridealso consisting of 30 patients, was administered prucapride as a monotherapy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Auricular Acupoint Stimulation +prucaprideThe study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride | Other | study group |
| prucapridewas administered prucapride as a monotherapy | Drug | control group |
Primary outcome
overall efficacy rate
Time frame: From enrollment to the end of treatment at one week
Symptoms were assessed both one week prior to and one week following treatment. The defecation time (scored as follows: 0 for ≤5 minutes; 1 for >5 to ≤15 minutes; 2 for >15 to ≤25 minutes; and 3 for >25 minutes) and the inter defecation interval (scored as the number of hours divided by 24) were recorded. The efficacy index was calculated using the formula: [(pretreatment score - posttreatment score)/ pretreatment score] × 100%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial, only IPD used in the results publication
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auricular Acupoint Stimulation +prucapride and prucapride in people with Slow Transmission Constipation, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heng Deng, Dr. (+8613335510159, tangkun23@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall efficacy rate (time frame: From enrollment to the end of treatment at one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.