ConstipationNCT07751224
Auricular Acupuncture for Post-Stroke Constipation
A study testing Auricular Acupuncture in people with Constipation and Stroke, run by Ho Chi Minh City Orthopedics and Rehabilitation Hospital at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if auricular acupuncture can improve constipation in hospitalized patients with post-stroke constipation. It will also evaluate whether auricular acupuncture is safe when used together with standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Stroke, Post-stroke Constipation
- What is being tested?
- Auricular Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2024to 1 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Hospitalized patients with stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
- Glasgow Coma Scale score >= 14
- Diagnosed with constipation according to the Constipation Assessment Scale (CAS) with a score > 2 and constipation duration of less than 1 week
- No history of gastrointestinal study
- Receiving routine rehabilitation therapy, including body acupuncture, massage therapy, and physical rehabilitation according to the hospital protocol
- Able to provide written informed consent
Who cannot join
- Inability to cooperate with study procedures because of cognitive impairment, psychiatric disorders, or severe communication difficulties after stroke.
- Skin lesions or infection involving the auricle.
- Pregnancy.
- Acute illness, exacerbation of chronic disease, malignant tumors, cancer, or severe dermatological disorders.
- Current use of medications known to cause constipation, including antidepressants, opioid analgesics, iron supplements, calcium channel blockers, or antacids.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Ho Chi Minh City Hospital of Orthpaedics and Rehabilitation
Ho Chi Minh City
About this study
Official title: Effectiveness of Auricular Acupuncture for Post-Stroke Constipation: A Randomized Sham-Controlled Trial
The goal of this clinical trial is to learn if auricular acupuncture can improve constipation in hospitalized patients with post-stroke constipation. It will also evaluate whether auricular acupuncture is safe when used together with standard care.
The main questions it aims to answer are:
Read more
- Does auricular acupuncture reduce constipation severity in patients with post-stroke constipation?
- Does auricular acupuncture intestinal symptoms compared with sham auricular acupuncture?
- Is auricular acupuncture safe for patients with post-stroke constipation? Researchers will compare auricular acupuncture plus standard care with sham auricular acupuncture plus standard care to determine whether auricular acupuncture provides additional benefits in relieving constipation symptoms.
Participants will:
- Be randomly assigned to receive either auricular acupuncture or sham auricular acupuncture
- Receive one treatment session daily for 8 consecutive treatment days in addition to standard care.
- Complete assessment of constipation severity and intestinal symptoms before and during the study.
- Be monitored for any adverse events throughout the study.
Read the detailed description
Post-stroke constipation (PSC) is one of the most common gastrointestinal complications after stroke and is associated with prolonged hospitalization, impaired rehabilitation, reduced quality of life, and poorer functional outcomes. Conventional management, including laxatives, dietary modification, and bowel training, may improve constipation symptoms; however, many patients continue to experience persistent bowel dysfunction despite these treatments. Therefore, safe and effective adjunctive therapies are needed to optimize bowel management during stroke rehabilitation.
Auricular acupuncture is a non-pharmacological intervention that has been increasingly used to manage gastrointestinal disorders. Previous experimental and clinical studies suggest that stimulation of specific auricular acupoints may regulate autonomic nervous system activity, improve gastrointestinal motility, and modulate the gut-brain axis. Although several studies have reported beneficial effects of auricular acupuncture for constipation, evidence regarding its effectiveness in patients with post-stroke constipation remains limited, particularly from randomized sham-controlled clinical trials.
This study was conducted to evaluate the effectiveness and safety of auricular acupuncture as an adjunct to standard care in hospitalized patients with post-stroke constipation. Participants were randomly assigned to receive either auricular acupuncture plus standard care or sham auricular acupuncture plus standard care. Constipation severity, intestinal symptoms, bowel function, and adverse events were evaluated during the intervention period to compare the therapeutic effects between the two groups.
The findings of this study are expected to provide additional clinical evidence regarding the role of auricular acupuncture as an adjunctive treatment for post-stroke constipation and may contribute to the development of evidence-based rehabilitation strategies for patients recovering from stroke.
- Conditions
- Constipation, Stroke, Post-stroke Constipation
- Being tested
- Auricular Acupuncture, Sham Auricular Acupuncture
- Keywords
- Auricular Acupuncture, Post-Stroke Constipation, Stroke Rehabilitation, Constipation, Randomized Controlled Trial, Sham-Controlled Trial, Complementary Therapy, Traditional Medicine
- Medical subject headings
- Constipation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureProcedure or surgery
Auricular acupuncture was performed at six therapeutic auricular acupoints (AH6a, HX2, TF3, CO7, CO17, and CO14) on the left ear. Needles were manually stimulated for 30 seconds every 5 minutes during each 20-minute treatment session. Treatment was administered once daily, five sessions per week, for eight treatment days.
Sham Auricular AcupunctureProcedure or surgery
Sham auricular acupuncture was performed at six non-therapeutic auricular points (SF1, SF2, SF3, AH1, AH2, and AH3) using the same needle manipulation, treatment duration, and treatment schedule as the experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupuncture + Standard Care | Experimental | Participants received auricular acupuncture in addition to standard care. Auricular acupuncture was administered once daily for 20 minutes, five sessions per week for eight treatment days. Standard care included lactulose therapy (Duphalac), dietary and lifestyle counseling, body acupuncture, massage therapy, and rehabilitation therapy according to the hospital protocol. Receives: Procedure: Auricular Acupuncture |
| Sham Auricular Acupuncture + Standard Care | Sham comparator | Participants received sham auricular acupuncture in addition to the same standard care as the experimental group. Sham auricular acupuncture was administered using non-therapeutic auricular points with the same treatment schedule as the experimental intervention. Standard care included lactulose therapy (Duphalac), dietary and lifestyle counseling, body acupuncture, massage therapy, and rehabilitation therapy according to the hospital protocol. Receives: Procedure: Sham Auricular Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Assessment Scale (CAS) score
The Constipation Assessment Scale (CAS) is an 8-item validated instrument used to assess the severity of constipation. Total scores range from 0 to 16, with higher scores indicating more severe constipation.
Measured: Baseline and Days 1, 3, 5, and 8 after treatment initiation
Secondary outcomes (2)
Intestinal Symptom Score
Intestinal symptoms were assessed using the Ten-Item Intestinal Symptoms Rating Scale. Higher score indicate more severe intestinal symptom
Measured: Baseline and Days 1, 3, 5, and 8 after treatment initiation
Adverse events
Incidence of adverse events related to study interventions
Measured: Throughout the 8-day intervention periof
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Nov 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Study Model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ho Chi Minh City Orthopedics and Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751224
- Sponsor's protocol ID
- BV1A-YHCT02
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be shared. This includes baseline demographic and clinical characteristics, Constipation Assessment Scale (CAS) scores, intestinal symptom scores, adverse event data, and the study protocol and statistical analysis plan. All shared data will be fully de-identified to protect participant confidentiality.
Publications
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287-291.
Cheng J, Li L, Xu F, Xu Y, Lin L, Chen JDZ. Poststroke Constipation Is Associated With Impaired Rectal Sensation. Am J Gastroenterol. 2020 Jan;115(1):105-114. doi: 10.14309/ajg.0000000000000479.
PubMed 31809301Suenghataiphorn T, Yanpiset P, Xanthavanij N, Srikulmontri T, Thiravetyan B, Tribuddharat N, Prasitsumrit V, Danpanichkul P, Sodsri T, Kulthamrongsri N, Wattanachayakul P. Increased Risk of Stroke in Constipation Patients: Systematic Review and Meta-analysis. J Clin Gastroenterol. 2026 Jan 1;60(1):54-60. doi: 10.1097/MCG.0000000000002127.
PubMed 39761158Lv Z, Fan S, Ma X, Liu F, Wu H, Shi Z, Wang M, Yu T, Wang P, Liu S, Ji Y. New-onset constipation at acute stage after stroke: incidence, risk factors, and impact on stroke rehabilitation. Front Neurol. 2026 Apr 15;17:1721157. doi: 10.3389/fneur.2026.1721157. eCollection 2026.
PubMed 42064981Feng S, Wu X, Dai X, Liu Z, Luo Y, Wang F. Comparative effectiveness of multiple different non-pharmacologic interventions for post-stroke constipation: a Bayesian network meta-analysis. Front Neurol. 2025 Oct 10;16:1591620. doi: 10.3389/fneur.2025.1591620. eCollection 2025.
PubMed 41142145Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.
PubMed 33355897van Etten ES, Kaushik K, Jolink WMT, Koemans EA, Ekker MS, Rasing I, Voigt S, Schreuder FHBM, Cannegieter SC, Rinkel GJE, Lijfering WM, Klijn CJM, Wermer MJH. Trigger Factors for Spontaneous Intracerebral Hemorrhage: A Case-Crossover Study. Stroke. 2022 May;53(5):1692-1699. doi: 10.1161/STROKEAHA.121.036233. Epub 2021 Dec 16.
PubMed 34911344Truyen TTTT, Vo NLY, Vo QP, Phan TC, Le PNB, Nguyen HT, Heckard E, Liu H, Nguyen TQ, Nguyen TH, Nguyen TN, Zuin M, Nguyen T. Burden and risk factors of stroke in Vietnam from 1990 to 2021 - a systematic analysis from global burden disease 2021. J Stroke Cerebrovasc Dis. 2025 Mar;34(3):108241. doi: 10.1016/j.jstrokecerebrovasdis.2025.108241. Epub 2025 Jan 16.
PubMed 39826583
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auricular Acupuncture for Post-Stroke Constipation: A Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07751224
- Acronym / sponsor ID
- BV1A-YHCT02
- Conditions
- Constipation, Stroke, Post-stroke Constipation
- Keywords
- Auricular Acupuncture, Post-Stroke Constipation, Stroke Rehabilitation, Constipation, Randomized Controlled Trial, Sham-Controlled Trial, Complementary Therapy, Traditional Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ho Chi Minh City Orthopedics and Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 7 Aug 2026 (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 goal of this clinical trial is to learn if auricular acupuncture can improve constipation in hospitalized patients with post-stroke constipation. It will also evaluate whether auricular acupuncture is safe when used together with standard care.
The main questions it aims to answer are:
- Does auricular acupuncture reduce constipation severity in patients with post-stroke constipation?
- Does auricular acupuncture intestinal symptoms compared with sham auricular acupuncture?
- Is auricular acupuncture safe for patients with post-stroke constipation? Researchers will compare auricular acupuncture plus standard care with sham auricular acupuncture plus standard care to determine whether auricular acupuncture provides additional benefits in relieving constipation symptoms.
Participants will:
- Be randomly assigned to receive either auricular acupuncture or sham auricular acupuncture
- Receive one treatment session daily for 8 consecutive treatment days in addition to standard care.
- Complete assessment of constipation severity and intestinal symptoms before and during the study.
- Be monitored for any adverse events throughout the study.
Detailed description
Post-stroke constipation (PSC) is one of the most common gastrointestinal complications after stroke and is associated with prolonged hospitalization, impaired rehabilitation, reduced quality of life, and poorer functional outcomes. Conventional management, including laxatives, dietary modification, and bowel training, may improve constipation symptoms; however, many patients continue to experience persistent bowel dysfunction despite these treatments. Therefore, safe and effective adjunctive therapies are needed to optimize bowel management during stroke rehabilitation.
Auricular acupuncture is a non-pharmacological intervention that has been increasingly used to manage gastrointestinal disorders. Previous experimental and clinical studies suggest that stimulation of specific auricular acupoints may regulate autonomic nervous system activity, improve gastrointestinal motility, and modulate the gut-brain axis. Although several studies have reported beneficial effects of auricular acupuncture for constipation, evidence regarding its effectiveness in patients with post-stroke constipation remains limited, particularly from randomized sham-controlled clinical trials.
This study was conducted to evaluate the effectiveness and safety of auricular acupuncture as an adjunct to standard care in hospitalized patients with post-stroke constipation. Participants were randomly assigned to receive either auricular acupuncture plus standard care or sham auricular acupuncture plus standard care. Constipation severity, intestinal symptoms, bowel function, and adverse events were evaluated during the intervention period to compare the therapeutic effects between the two groups.
The findings of this study are expected to provide additional clinical evidence regarding the role of auricular acupuncture as an adjunctive treatment for post-stroke constipation and may contribute to the development of evidence-based rehabilitation strategies for patients recovering from stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional Study Model
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture + Standard Care | Experimental | Procedure: Auricular AcupunctureParticipants received auricular acupuncture in addition to standard care. Auricular acupuncture was administered once daily for 20 minutes, five sessions per week for eight treatment days. Standard care included lactulose therapy (Duphalac), dietary and lifestyle counseling, body acupuncture, massage therapy, and rehabilitation therapy according to the hospital protocol. |
| Sham Auricular Acupuncture + Standard Care | Sham comparator | Procedure: Sham Auricular AcupunctureParticipants received sham auricular acupuncture in addition to the same standard care as the experimental group. Sham auricular acupuncture was administered using non-therapeutic auricular points with the same treatment schedule as the experimental intervention. Standard care included lactulose therapy (Duphalac), dietary and lifestyle counseling, body acupuncture, massage therapy, and rehabilitation therapy according to the hospital protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Hospitalized patients with stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
- Glasgow Coma Scale score >= 14
- Diagnosed with constipation according to the Constipation Assessment Scale (CAS) with a score > 2 and constipation duration of less than 1 week
- No history of gastrointestinal study
Key exclusion criteria (5 listed)
- Inability to cooperate with study procedures because of cognitive impairment, psychiatric disorders, or severe communication difficulties after stroke.
- Skin lesions or infection involving the auricle.
- Pregnancy.
- Acute illness, exacerbation of chronic disease, malignant tumors, cancer, or severe dermatological disorders.
- Current use of medications known to cause constipation, including antidepressants, opioid analgesics, iron supplements, calcium channel blockers, or antacids.
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 AcupunctureAuricular acupuncture was performed at six therapeutic auricular acupoints (AH6a, HX2, TF3, CO7, CO17, and CO14) on the left ear. Needles were manually stimulated for 30 seconds every 5 minutes during each 20-minute treatment session. Treatment was administered once daily, five sessions per week, for eight treatment days. | Procedure or surgery | Auricular Acupuncture + Standard Care |
| Sham Auricular AcupunctureSham auricular acupuncture was performed at six non-therapeutic auricular points (SF1, SF2, SF3, AH1, AH2, and AH3) using the same needle manipulation, treatment duration, and treatment schedule as the experimental intervention. | Procedure or surgery | Sham Auricular Acupuncture + Standard Care |
Primary outcome
Constipation Assessment Scale (CAS) score
Time frame: Baseline and Days 1, 3, 5, and 8 after treatment initiation
The Constipation Assessment Scale (CAS) is an 8-item validated instrument used to assess the severity of constipation. Total scores range from 0 to 16, with higher scores indicating more severe constipation.
2 secondary outcomes
Intestinal Symptom Score
Time frame: Baseline and Days 1, 3, 5, and 8 after treatment initiation
Adverse events
Time frame: Throughout the 8-day intervention periof
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 7 Aug 2026.
- BackgroundJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287-291.
- Background: PubMed 31809301Cheng J, Li L, Xu F, Xu Y, Lin L, Chen JDZ. Poststroke Constipation Is Associated With Impaired Rectal Sensation. Am J Gastroenterol. 2020 Jan;115(1):105-114. doi: 10.14309/ajg.0000000000000479.
- Background: PubMed 39761158Suenghataiphorn T, Yanpiset P, Xanthavanij N, Srikulmontri T, Thiravetyan B, Tribuddharat N, Prasitsumrit V, Danpanichkul P, Sodsri T, Kulthamrongsri N, Wattanachayakul P. Increased Risk of Stroke in Constipation Patients: Systematic Review and Meta-analysis. J Clin Gastroenterol. 2026 Jan 1;60(1):54-60. doi: 10.1097/MCG.0000000000002127.
- Background: PubMed 42064981Lv Z, Fan S, Ma X, Liu F, Wu H, Shi Z, Wang M, Yu T, Wang P, Liu S, Ji Y. New-onset constipation at acute stage after stroke: incidence, risk factors, and impact on stroke rehabilitation. Front Neurol. 2026 Apr 15;17:1721157. doi: 10.3389/fneur.2026.1721157. eCollection 2026.
- Background: PubMed 41142145Feng S, Wu X, Dai X, Liu Z, Luo Y, Wang F. Comparative effectiveness of multiple different non-pharmacologic interventions for post-stroke constipation: a Bayesian network meta-analysis. Front Neurol. 2025 Oct 10;16:1591620. doi: 10.3389/fneur.2025.1591620. eCollection 2025.
- Background: PubMed 33355897Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.
- Background: PubMed 34911344van Etten ES, Kaushik K, Jolink WMT, Koemans EA, Ekker MS, Rasing I, Voigt S, Schreuder FHBM, Cannegieter SC, Rinkel GJE, Lijfering WM, Klijn CJM, Wermer MJH. Trigger Factors for Spontaneous Intracerebral Hemorrhage: A Case-Crossover Study. Stroke. 2022 May;53(5):1692-1699. doi: 10.1161/STROKEAHA.121.036233. Epub 2021 Dec 16.
- Background: PubMed 39826583Truyen TTTT, Vo NLY, Vo QP, Phan TC, Le PNB, Nguyen HT, Heckard E, Liu H, Nguyen TQ, Nguyen TH, Nguyen TN, Zuin M, Nguyen T. Burden and risk factors of stroke in Vietnam from 1990 to 2021 - a systematic analysis from global burden disease 2021. J Stroke Cerebrovasc Dis. 2025 Mar;34(3):108241. doi: 10.1016/j.jstrokecerebrovasdis.2025.108241. Epub 2025 Jan 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be shared. This includes baseline demographic and clinical characteristics, Constipation Assessment Scale (CAS) scores, intestinal symptom scores, adverse event data, and the study protocol and statistical analysis plan. All shared data will be fully de-identified to protect participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture in people with Constipation and Stroke, run by Ho Chi Minh City Orthopedics and Rehabilitation Hospital at 1 site in Vietnam.
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 7 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 7 Aug 2026. 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 Vietnam. 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.
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?
Constipation Assessment Scale (CAS) score (time frame: Baseline and Days 1, 3, 5, and 8 after treatment initiation). 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 NCT07751224, which also lists 8 linked publications.
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 7 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.