Heart FailureNCT05988502
Auricular Acupressure Relieves Constipation for Patients With Heart Failure in Hospital
A study testing auricular acupressure in people with Heart Failure and Auricular Acupressure, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aimed to investigate the effect of auricular acupressure (AA) to relieve constipation symptoms and improve quality of life in patients hospitalized for their heart failure. A total of 72 participants were randomly assigned and 68 (33 in the AA group and 35 in the control group) completed the study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Auricular Acupressure, Constipation
- What is being tested?
- auricular acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Mar 2022to 30 Oct 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA) functional classes I-III
- Constipation(had fewer than three bowel movements a week)
- Conscious clear and communicable
Who cannot join
- Other serious diseases
- Wounds or infections in both ears
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auricular Acupressure Relieves Constipation for Patients With Heart Failure in Hospital: a Randomised Controlled Trial
This study aimed to investigate the effect of auricular acupressure (AA) to relieve constipation symptoms and improve quality of life in patients hospitalized for their heart failure. A total of 72 participants were randomly assigned and 68 (33 in the AA group and 35 in the control group) completed the study. Outcomes were measured by the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Beck Anxiety Inventory and Beck Depression Inventory at baseline, Weeks 1 and 2, as well as Constitution in Chinese Medicine Questionnaire and Patient Assessment of Constipation Quality of Life at baseline and Week 2.
Read the detailed description
- Study Design This was a parallel randomized controlled trial with two groups; the auricular acupressure (AA) group was given auricular acupressure for two weeks and the control group received usual care for heart failure during the same study period. Data were collected consisted of three repeated measurement time points at baseline, Week 1, and Week 2.
- Participants This study consecutively recruited patients who were hospitalized for treating heart failure from the cardiology ward of the a medical center in northern Taiwan. Patients who aged over 20 years and had the New York Heart Association (NYHA) functional classes I-III, constipation(had fewer than three bowel movements a week), and conscious clear and communicable were included, while those who had serious diseases or wounds or infections in both ears were excluded. The sample size required for the study was estimated using G-power software vers.3.1. (Heinrich Heine Universitat, Dusseldorf, Germany), with an effect size of 0.3 referring to the previous study on constipation, the significance level (α) at .05, and 80% statistical power. With considering a 10% dropout rate, a total of 72
- Randomization and allocation concealment The participants were randomized into two groups by a research team not involved in the study intervention or data collection. The randomization process was accomplished through a computer-generated sequence of random numbers, and permuted block randomization was employed with four in each block. The random sequence of numbers was separately and sequentially stored in sealed, opaque envelopes that were opened in front of the participants in the predetermined order, which determined their group allocation.
- The auricular acupressure (AA) intervention The AA intervention selected seven acupoints on auricle, including Shenmen (TF4), Intestine (CO7), Rectum (HX2), San Jiao (CO17), Spleen (CO13), Lung (CO14) and Subcortex (AT4), as seen Figure 2 (intestine, rectum, San Jiao, spleen, lung, and subcortex). The well-trained researcher nurse in this study was performed the AA intervention. First of all, the participant was instructed to find a comfortable position. Disinfect the ears using cotton with 75 % alcohol was then provided and followed by placed vaccaria seeds (Beijing, China) with an adhesive patch onto the unilateral each selected auricular acupoint (left ear first). Participants were pressed each acupoint by thumb and index finger for one minute, four times a day, five days a week, remove the taped seeds on the 6th day, and then replaced the opposite ear two days after. They were noted that they experienced various sensations while pressing, including numbness, swelling, mild pain, or warmth. Seeds were taped on the other side of the ear weekly for two weeks. Two TCM physicians verified the conduct of the AA protocol, which consisted of a selection of acupoints, length of stimulation time, finding location of acupoint, and procedure of practice. In addition, all participants received the same routine care which was general heart failure care and medications for constipation therapy provided by the study hospital professionals. Prior to the study, every participant was assessed by the cardiologist and identified as being appropriate and safe. Data collection was conducted by the same researcher nurse at baseline, Week 1, and Week 2.
- Measurements Outcomes were assessed by using the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Constitution in Chinese Medicine Questionnaire, Beck Anxiety Inventory, Beck Depression Inventory II and Patient Assessment of Constipation Quality Of Life；The 1th week follow-up assessment instruments included the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Beck Anxiety Inventory and Beck Depression Inventory II.
- Statistical analysis Data were analyzed using SPSS 26.0 for Windows (IBM, Chicago, IL, USA). continuous variables are reported as means and standard deviations (SD), and categorical variables are reported as the number of samples and percentages. Homogeneity was tested by the Chi-square test and independent t test. Intervention effects on outcomes between the groups across repeated measurement times were analyzed by the linear mixed model using an exchangeable working correlation structure and time treated as a categorical variable that was represented by two dummy-coded variables. This study a value of p < 0.05 was considered statistically significant.
- Being tested
- auricular acupressure
- Keywords
- Anxiety, auricular acupressure, constipation, heart failure, quality of life, Depression
- Medical subject headings
- Heart Failure, Constipation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureOther
The well-trained researcher nurse in this study was performed the AA intervention. First of all, the participant was instructed to find a comfortable position. Disinfect the ears using cotton with 75 % alcohol was then provided and followed by placed vaccaria seeds (Beijing, China) with an adhesive patch onto the unilateral each selected auricular acupoint (left ear first) Participants were pressed each acupoint by thumb and index finger for one minute, four times a day, five days a week, remove the taped seeds on the 6th day, and then replaced the opposite ear two days after. They were noted that they experienced various sensations while pressing, including numbness, swelling, mild pain, or warmth. Seeds were taped on the other side of the ear weekly for two weeks.
Two TCM physicians verified the conduct of the AA protocol, which consisted of a selection of acupoints, length of stimulation time, finding location of acupoint, and procedure of practice.
| Study group | Role | What they receive |
|---|---|---|
| auricular acupressure (AA) group | Experimental | the auricular acupressure (AA) group was given auricular acupressure for two weeks Receives: Other: auricular acupressure |
| control group | No intervention | all participants received the same routine care which was general heart failure care and medications for constipation therapy provided by the study hospital professionals. Prior to the study, every participant was assessed by the cardiologist and identified as being appropriate and safe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline constipation at 2 weeks by using the Bristolv Stool Form Scale
Outcomes were assessed by using the Bristolv Stool Form Scale. This scale categorized tools between type 1 (hard lumps) and type 7 (watery diaphragm). Type 1 was separate hard lump like nuts(hard to pass), type 2 was sausage-shaped but lumpy, type 3 was like a sausage but with cracks on its surface, type 4 was like a sausage or snake, smooth and soft, type 5 was soft blobs with clear-cut edges (passed easily), type 6 is fluffy pieces with ragged edges (a mushy stool), and type 7 was watery, no solid pieces (entirely liquid). Stool types were then classified based on the Rome III criteria as stool types 1 and 2 as constipation, types 3, 4, and 5 as normal stool form, and types 6 and 7 as diarrhea,
Measured: baseline, Weeks 1 and 2
Change from Baseline constipation at 2 weeks by using the Constipation Assessment Scale
Outcomes were assessed by using the Constipation Assessment Scale. The CAS comprised of 8 items, and each item used a 3-point Likert-type scale ranging 0~2, with a total score of 0 to 16. A higher score indicated severer constipation symptom.
Measured: baseline, Weeks 1 and 2
Change from Baseline constipation at 2 weeks by using the Visual Scale Analog for constipation
Outcomes were assessed by using the Visual Scale Analog for constipation. The VSAQ was used to measure the immediate severity of constipation, with a 10 cm straight line with 0 on the far left (0 score) and 10 cm (10 scores) on the far right. A score ≥ 3 indicated constipation, a higher score indicating severer constipation,
Measured: baseline, Weeks 1 and 2
Change from Baseline constipation at 2 weeks by using the Patient Assessment of Constipation Symptoms .
Outcomes were assessed by using the Patient Assessment of Constipation Symptoms .This scale comprised of 12 items with 3 subscales, including stool symptoms, rectal symptoms, and abdominal symptoms. Each item used a 5-point Likert-type scale ranging 0~4, with a total score of 0 to 48. A higher score indicated symptom severity.
Measured: baseline, Weeks 1 and 2
Secondary outcomes (4)
Change from Baseline Body constitution in Chinese Medicine at 2 weeks
Outcomes were assessed by using the Constitution in Chinese Medicine Questionnaire. It consisted of 60 items and categorized into 9 subscales, including yang-deficient (7 items), yin-deficient (8 items), qi-deficient (8 items), phlegm-dampness (8 items), damp-heat (6 items), stagnant blood (7 items), inherited special (7 items), stagnant qi (7 items), and balanced (8 items). The items were on a 5-point Likert scale, with high scores indicating a higher likelihood of having the given body constitution. A threshold of 30 or higher points on a subscale was used to classify having that body constitution.
Measured: at baseline, Weeks 2
Change from Baseline Anxiety at 2 weeks
Outcomes were assessed by using the Beck Anxiety Inventory. This scale consisted of 21 items that used a 4-point Likert-type scale ranging 0~3, with a total score of 0 to 63. The normal score range was 0-16, 17-22 for mild anxiety, 23-30 for moderate anxiety , and 31-63 for severe anxiety.
Measured: at baseline, Weeks 1 and 2
Change from Baseline Depression at 2 weeks
Outcomes were assessed by using the Beck Depression Inventory II. This scale consisted of 21 items that used a 4-point Likert-type scale ranging 0~3, with a total score of 0 to 63. The normal score range was 0-16, 17-22 for mild depression, 23-30 for moderate depression, and 31-63 for severe depression.
Measured: at baseline, Weeks 1 and 2
Patient Assessment of Constipation Quality of Life
Outcomes were assessed by using the Patient Assessment of Constipation Quality of Life, constipation affecting in daily life. It comprised of 28 items with 4 subscales, including worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction. Each item used a 5-point Likert-type scale ranging 0~4, with a total score of 0 to 112. A lower score indicated better quality of life.
Measured: at baseline, Weeks 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Mar 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomized into two groups by a research team not involved in the study intervention or data collection. The randomization process was accomplished through a computer-generated sequence of random numbers, and permuted block randomization was employed with four in each block. The random sequence of numbers was separately and sequentially stored in sealed, opaque envelopes that were opened in front of the participants in the predetermined order, which determined their group allocation.the auricular acupressure (AA) group was given auricular acupressure for two weeks and the control group received usual care for heart failure during the same study period. Data were collected consisted of three repeated measurement time points at baseline, Week 1, and Week 2.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Ting Chen, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988502
- Sponsor's protocol ID
- 110269-F
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupressure Relieves Constipation for Patients With Heart Failure in Hospital: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05988502
- Acronym / sponsor ID
- 110269-F
- Keywords
- Anxiety, auricular acupressure, constipation, heart failure, quality of life, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 14 Aug 2023 (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.
This study aimed to investigate the effect of auricular acupressure (AA) to relieve constipation symptoms and improve quality of life in patients hospitalized for their heart failure. A total of 72 participants were randomly assigned and 68 (33 in the AA group and 35 in the control group) completed the study. Outcomes were measured by the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Beck Anxiety Inventory and Beck Depression Inventory at baseline, Weeks 1 and 2, as well as Constitution in Chinese Medicine Questionnaire and Patient Assessment of Constipation Quality of Life at baseline and Week 2.
Detailed description
- Study Design This was a parallel randomized controlled trial with two groups; the auricular acupressure (AA) group was given auricular acupressure for two weeks and the control group received usual care for heart failure during the same study period. Data were collected consisted of three repeated measurement time points at baseline, Week 1, and Week 2.
- Participants This study consecutively recruited patients who were hospitalized for treating heart failure from the cardiology ward of the a medical center in northern Taiwan. Patients who aged over 20 years and had the New York Heart Association (NYHA) functional classes I-III, constipation(had fewer than three bowel movements a week), and conscious clear and communicable were included, while those who had serious diseases or wounds or infections in both ears were excluded. The sample size required for the study was estimated using G-power software vers.3.1. (Heinrich Heine Universitat, Dusseldorf, Germany), with an effect size of 0.3 referring to the previous study on constipation, the significance level (α) at .05, and 80% statistical power. With considering a 10% dropout rate, a total of 72
- Randomization and allocation concealment The participants were randomized into two groups by a research team not involved in the study intervention or data collection. The randomization process was accomplished through a computer-generated sequence of random numbers, and permuted block randomization was employed with four in each block. The random sequence of numbers was separately and sequentially stored in sealed, opaque envelopes that were opened in front of the participants in the predetermined order, which determined their group allocation.
- The auricular acupressure (AA) intervention The AA intervention selected seven acupoints on auricle, including Shenmen (TF4), Intestine (CO7), Rectum (HX2), San Jiao (CO17), Spleen (CO13), Lung (CO14) and Subcortex (AT4), as seen Figure 2 (intestine, rectum, San Jiao, spleen, lung, and subcortex). The well-trained researcher nurse in this study was performed the AA intervention. First of all, the participant was instructed to find a comfortable position. Disinfect the ears using cotton with 75 % alcohol was then provided and followed by placed vaccaria seeds (Beijing, China) with an adhesive patch onto the unilateral each selected auricular acupoint (left ear first). Participants were pressed each acupoint by thumb and index finger for one minute, four times a day, five days a week, remove the taped seeds on the 6th day, and then replaced the opposite ear two days after. They were noted that they experienced various sensations while pressing, including numbness, swelling, mild pain, or warmth. Seeds were taped on the other side of the ear weekly for two weeks. Two TCM physicians verified the conduct of the AA protocol, which consisted of a selection of acupoints, length of stimulation time, finding location of acupoint, and procedure of practice. In addition, all participants received the same routine care which was general heart failure care and medications for constipation therapy provided by the study hospital professionals. Prior to the study, every participant was assessed by the cardiologist and identified as being appropriate and safe. Data collection was conducted by the same researcher nurse at baseline, Week 1, and Week 2.
- Measurements Outcomes were assessed by using the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Constitution in Chinese Medicine Questionnaire, Beck Anxiety Inventory, Beck Depression Inventory II and Patient Assessment of Constipation Quality Of Life；The 1th week follow-up assessment instruments included the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Beck Anxiety Inventory and Beck Depression Inventory II.
- Statistical analysis Data were analyzed using SPSS 26.0 for Windows (IBM, Chicago, IL, USA). continuous variables are reported as means and standard deviations (SD), and categorical variables are reported as the number of samples and percentages. Homogeneity was tested by the Chi-square test and independent t test. Intervention effects on outcomes between the groups across repeated measurement times were analyzed by the linear mixed model using an exchangeable working correlation structure and time treated as a categorical variable that was represented by two dummy-coded variables. This study a value of p < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants were randomized into two groups by a research team not involved in the study intervention or data collection. The randomization process was accomplished through a computer-generated sequence of random numbers, and permuted block randomization was employed with four in each block. The random sequence of numbers was separately and sequentially stored in sealed, opaque envelopes that were opened in front of the participants in the predetermined order, which determined their group allocation.the auricular acupressure (AA) group was given auricular acupressure for two weeks and the control group received usual care for heart failure during the same study period. Data were collected consisted of three repeated measurement time points at baseline, Week 1, and Week 2.
| Arm | Type | Receives |
|---|---|---|
| auricular acupressure (AA) group | Experimental | Other: auricular acupressurethe auricular acupressure (AA) group was given auricular acupressure for two weeks |
| control group | No intervention | –all participants received the same routine care which was general heart failure care and medications for constipation therapy provided by the study hospital professionals. Prior to the study, every participant was assessed by the cardiologist and identified as being appropriate and safe. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New York Heart Association (NYHA) functional classes I-III
- Constipation(had fewer than three bowel movements a week)
- Conscious clear and communicable
Key exclusion criteria (2 listed)
- Other serious diseases
- Wounds or infections in both ears
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 acupressureThe well-trained researcher nurse in this study was performed the AA intervention. First of all, the participant was instructed to find a comfortable position. Disinfect the ears using cotton with 75 % alcohol was then provided and followed by placed vaccaria seeds (Beijing, China) with an adhesive patch onto the unilateral each selected auricular acupoint (left ear first) Participants were pressed each acupoint by thumb and index finger for one minute, four times a day, five days a week, remove the taped seeds on the 6th day, and then replaced the opposite ear two days after. They were noted that they experienced various sensations while pressing, including numbness, swelling, mild pain, or warmth. Seeds were taped on the other side of the ear weekly for two weeks. Two TCM physicians verified the conduct of the AA protocol, which consisted of a selection of acupoints, length of stimulation time, finding location of acupoint, and procedure of practice. | Other | auricular acupressure (AA) group |
Primary outcome
Change from Baseline constipation at 2 weeks by using the Bristolv Stool Form Scale
Time frame: baseline, Weeks 1 and 2
Outcomes were assessed by using the Bristolv Stool Form Scale. This scale categorized tools between type 1 (hard lumps) and type 7 (watery diaphragm). Type 1 was separate hard lump like nuts(hard to pass), type 2 was sausage-shaped but lumpy, type 3 was like a sausage but with cracks on its surface, type 4 was like a sausage or snake, smooth and soft, type 5 was soft blobs with clear-cut edges (passed easily), type 6 is fluffy pieces with ragged edges (a mushy stool), and type 7 was watery, no solid pieces (entirely liquid). Stool types were then classified based on the Rome III criteria as stool types 1 and 2 as constipation, types 3, 4, and 5 as normal stool form, and types 6 and 7 as diarrhea,
Change from Baseline constipation at 2 weeks by using the Constipation Assessment Scale
Time frame: baseline, Weeks 1 and 2
Outcomes were assessed by using the Constipation Assessment Scale. The CAS comprised of 8 items, and each item used a 3-point Likert-type scale ranging 0~2, with a total score of 0 to 16. A higher score indicated severer constipation symptom.
Change from Baseline constipation at 2 weeks by using the Visual Scale Analog for constipation
Time frame: baseline, Weeks 1 and 2
Outcomes were assessed by using the Visual Scale Analog for constipation. The VSAQ was used to measure the immediate severity of constipation, with a 10 cm straight line with 0 on the far left (0 score) and 10 cm (10 scores) on the far right. A score ≥ 3 indicated constipation, a higher score indicating severer constipation,
Change from Baseline constipation at 2 weeks by using the Patient Assessment of Constipation Symptoms .
Time frame: baseline, Weeks 1 and 2
Outcomes were assessed by using the Patient Assessment of Constipation Symptoms .This scale comprised of 12 items with 3 subscales, including stool symptoms, rectal symptoms, and abdominal symptoms. Each item used a 5-point Likert-type scale ranging 0~4, with a total score of 0 to 48. A higher score indicated symptom severity.
4 secondary outcomes
Change from Baseline Body constitution in Chinese Medicine at 2 weeks
Time frame: at baseline, Weeks 2
Change from Baseline Anxiety at 2 weeks
Time frame: at baseline, Weeks 1 and 2
Change from Baseline Depression at 2 weeks
Time frame: at baseline, Weeks 1 and 2
Patient Assessment of Constipation Quality of Life
Time frame: at baseline, Weeks 2
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 16 Aug 2023.
- 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.
Yi-Ting Chen principal investigator
Far Eastern Memorial Hospital
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 acupressure in people with Heart Failure and Auricular Acupressure, run by Far Eastern Memorial 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 3 inclusion and 2 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 16 Aug 2023. 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. 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 from Baseline constipation at 2 weeks by using the Bristolv Stool Form Scale (time frame: baseline, Weeks 1 and 2). The study lists 4 primary outcomes in all. 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 16 Aug 2023.