Type 2 DiabetesNCT05707481
Impact of Clinical Pharmacist-Led Intervention on Management of Diabetic Hypertensive Patients in Eastern Nepal
A study testing Clinical Pharmacist-Led Educational Intervention in people with Type 2 Diabetes and Hypertension, run by Chettinad Academy of Research and Education (Deemed to be University) at 1 site in Nepal.
Trial summary
Diabetic-Hypertensives are at a higher risk of premature microvascular and macrovascular complications than diabetes alone. Proper lifestyle management, diet, disease monitoring, and medication adherence is essential in achieving desired therapeutic outcomes, preventing complications and improving those patients'… Read more about this study
- Who is it for?
- Ages 40 to 68 years
- Conditions the study is for
- Type 2 Diabetes, Hypertension
- What is being tested?
- Clinical Pharmacist-Led Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteNepal
- Study dates
- 22 Aug 2023to 4 Jul 2024
- 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 40 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 40 to 68 years.
- Clinically diagnosed with type II diabetes mellitus with hypertension as co-morbidity.
- Minimum one year of the medical history of diabetic and hypertension.
- Minimum 6 months on antidiabetic as well as antihypertensive medication therapy.
- Patients willing to participate in the study and those providing written informed consent for participation.
Who cannot join
- Patients with Type I diabetes mellitus, Diabetic insipidus, Gestational diabetes or other forms of diabetes.
- Presence of other chronic disease co-morbidity other than hypertension and diabetes complications.
- Mentally incompetent patients, Pregnant, critically ill patients (requiring hospital admission).
- Patients have tuberculosis, Corona virus, and other highly communicable diseases.
- Those patients not willing to performing routine follow-up visit.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Purbanchal University Hospital
Gothgaun,Sundar Haraicha Municipality, Morang, Koshi, 56600
About this study
Official title: Impact of Clinical Pharmacist Led Intervention on Management of Diabetic Hypertensive Patients.
Diabetic-Hypertensives are at a higher risk of premature microvascular and macrovascular complications than diabetes alone. Proper lifestyle management, diet, disease monitoring, and medication adherence is essential in achieving desired therapeutic outcomes, preventing complications and improving those patients' Health-Related Quality of Life (HRQoL). Pharmacists are the most accessible healthcare professionals to the public and have a crucial role in optimizing treatment outcomes in patients with chronic diseases such as diabetes and hypertension. Experimental trials' demonstrating the potential roles of pharmaceutical services is scarce in the literature, particularly in developing countries of south Asia. Therefore, the investigators plan to conduct a prospective-interventional trial to determine the potential impacts of pharmacist-supervised educational intervention on the management of "Type II diabetic with comorbid hypertension" patients. Patient data will be collected using patient's clinical profile forms, General Medication adherence Scale (GMAS), Patients Satisfaction towards pharmaceutical services (PSPSQ), Health Related-KAP questionnaires. Data will be verified, stored, entered into databases, and analyzed according to the data management plan. The findings will be compared in terms of clinical and nonclinical outcome measures between the control and test groups to ascertain the conclusion.
Read the detailed description
Diabetics are twice as likely as non-diabetics to develop hypertension. Hypertension is a strong predictor of adverse cerebulo-vascular and cardiovascular events in people with diabetes, which increases risk of Premature micro-vascular and macro-vascular problems in patients encompassing both diseases. Therefore, strict glycemic and blood pressure control is essential to subdue complication and prevent dreadful cardiovascular events such as stroke, Ischemia and myocardial infarction. Participants with both chronic diseases may have lower HRQoL due to increased susceptibility towards cardiovascular comorbidities. Adherence to medication is equally crucial for treatment success. Pharmacist in collaboration with other healthcare members, could play a vital role in the care of patients and optimizing treatment outcomes in patients with chronic diseases .
Chronic disease management is of particular interest to clinical pharmacist since most intervention requires long-term prescription medication use. The international pharmaceutical federation (FIP) and world health organization (WHO) have implored pharmacists to support people with chronic disease through their expanded role that includes "pharmaceutical care." In Nepal, Clinical Pharmacy practice is still in early infancy, though few studies have shown encouraging impacts of pharmaceutical care services. Similarly, there is a significant gap in the literature in this region addressing the impact of pharmacist-supervised educational intervention on both clinical and nonclinical outcomes measures, primarily focusing on co-morbid Diabetes- Hypertensive patients. Therefore, these studies are intended to recap and fill that gap area and add new and valuable insight to the available literature.
- Conditions
- Type 2 Diabetes, Hypertension
- Being tested
- Clinical Pharmacist-Led Educational Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist-Led Educational InterventionOther
Non Pharmacological management strategies include information related to life style modification, healthy dietary habits, physical activity and stress management techniques. In contrast, pharmacological educational intervention involves disease -related information ( diabetes/hypertension sign and symptoms, risk factor, complications, self-monitoring of blood pressure/glucose, symptoms and management of hypoglycemia/hypotension etc. ) and drug related information ( prescribed drug name, indication, contraindication, adverse effects etc.) as well as importance of adherence to prescribed medication and strategies to minimize DRPs issues. These teaching sessions will be carried out with the help of verbal communication, audio visual demonstration (including charts,pictorial etc) and information leaflets. Furthermore, a copy of educational package would be given to each participant for reference and guidance.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Usual Standard Care) | No intervention | Control group patient will undergo routine care by their physician and nurses. However, the investigator will only provide basic counseling regarding drug prescribed during discharge to the patients. In another term "Usual care" will be provided to the patients |
| Intervention Group (Clinical Pharmacist-led educational Intervention) | Other | In addition to routine care by physician and nurses, Patients in interventional group will receive two consecutive face to face interview and counseling of 20-40 minutes during the baseline period and the first follow-up period at 3-month by clinical pharmacist. Teaching and counseling session involves information on various non-pharmacological and pharmacological disease management strategies. Receives: Other: Clinical Pharmacist-Led Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Assessed with measurement of Systolic and diastolic blood pressure in mmHg using sphygmomanometer
Measured: baseline, follow up at 3 months and 6 months respectively
Change in blood glycemic profile
Assessed with measurement of Fasting Blood Sugar (FBS) and Post Prandial Blood Sugar (PPBS) in mg/dl.
Measured: baseline, follow up at 3 months and 6 months respectively
change in glycosylated hemoglobin (HbA1C) level
assessed from patients glycosylated hemoglobin (HbA1C) level test, measured in percent (%)
Measured: baseline, follow up at 3 months and 6 months respectively
Impact of Intervention in Patients Medication Adherence
It will be measured using translated and validated Nepalese version of the 11-item Novel general medication adherence Scale (GMAS) questionnaire divided into three categories based on a four-level Likert scale. GMAS tools provide a wide range of components, including disease and medication burden, patient behavior both intentional and unintentional, and cost-related burden associated with non-adherence. Higher Scores better the outcomes, measured within categories and overall adherence level.
Measured: baseline, follow up at 3 months and 6 months respectively
Compare patients perceived Satisfaction of pharmaceutical care services
This will be assessed by using Nepali version of Patients Perceived satisfaction of Pharmacist care (PSPSQ. 2 ) questionnaire. This tool comprises 20 items questionnaire divided into three dimensions based on a four-point Likert scale. Dimensions include quality of care, pharmacist-patient relationships, and overall satisfaction. Higher scores represent better outcomes, measured within domains and overall satisfaction levels.
Measured: baseline, follow up at 3 months and 6 months respectively
Change in Health related Quality of Life
Translated Nepali version of Euro 5 D 5 L questionnaire measures will be used to measure patients' health-related quality of life (HRQoL). This questionnaire created by the European Quality of Life Group (EuroQol Group) measure HRQoL in five dimension Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels to describe the severity: no problem, slight problem, moderate problem, severe problem, and unable (very severe). The outcomes will be measured in the overall health utility index value. The index value ranges from -1 to 1 (0 indicates death, <0 indicates worse than death, and 1 indicates full health)
Measured: baseline, follow up at 3 months and 6 months respectively
Secondary outcomes (2)
Change in routine clinical laboratory parameters of patients Lipid Profile test.
Data will be obtained from routine clinical laboratory test of patients blood Lipid Profile ( Total cholesterol, High density lipoprotein (HDL) Cholesterol, Low density lipoprotein (LDL) cholesterol, Very low density lipoprotein (VLDL) Cholesterol, and Triglycerides) measured in mg/dl.
Measured: baseline, follow up at 3 months and 6 months respectively
Change in Patients health related Knowledge, Attitude and Practice
Patient knowledge, attitude and practice will be assessed using 25-item Disease related Health Knowledge, attitude and practice questionnaires developed by Investigators through literature review and content validated with a team of health care professionals. The higher the scores within domains better the outcomes.
Measured: baseline, follow up at 3 months and 6 months respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start22 Aug 2023
- Primary completion2 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chettinad Academy of Research and Education (Deemed to be University)
- Sponsor type
- University, hospital or other
- Collaborators
- Purbanchal University
- Responsible party
- Principal investigator, Dr. Prasanna Dahal, Chettinad Academy of Research and Education (Deemed to be University)
- Investigators
- Prasanna Dahal, PharmD, Principal investigator, Chettinad Academy of Research and Education (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707481
- Sponsor's protocol ID
- 382/2022 PhD
- Status last verified
- Feb 2025
- First submitted
- 6 Jan 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naqvi AA, Hassali MA, Jahangir A, Nadir MN, Kachela B. Translation and validation of the English version of the general medication adherence scale (GMAS) in patients with chronic illnesses. J Drug Assess. 2019 Feb 6;8(1):36-42. doi: 10.1080/21556660.2019.1579729. eCollection 2019.
PubMed 30863660Shrestha R, Sapkota B, Khatiwada AP, Shrestha S, Khanal S, Kc B, Paudyal V. Translation, Cultural Adaptation and Validation of General Medication Adherence Scale (GMAS) into the Nepalese Language. Patient Prefer Adherence. 2021 Aug 27;15:1873-1885. doi: 10.2147/PPA.S320866. eCollection 2021.
PubMed 34475753Sakharkar P, Bounthavong M, Hirsch JD, Morello CM, Chen TC, Law AV. Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services. Res Social Adm Pharm. 2015 Jul-Aug;11(4):487-98. doi: 10.1016/j.sapharm.2014.10.006. Epub 2014 Oct 22.
PubMed 25481330Shrestha S, Sapkota B, Thapa S, K C B, Khanal S. Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings. PLoS One. 2020 Oct 9;15(10):e0240488. doi: 10.1371/journal.pone.0240488. eCollection 2020.
PubMed 33035243
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacist Led Intervention on Management of Diabetic Hypertensive Patients.
- ClinicalTrials.gov ID
- NCT05707481
- Acronym / sponsor ID
- 382/2022 PhD
- Conditions
- Type 2 Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Chettinad Academy of Research and Education (Deemed to be University)University, hospital or other
- Collaborators
- Purbanchal University
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 1 Feb 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.
Diabetic-Hypertensives are at a higher risk of premature microvascular and macrovascular complications than diabetes alone. Proper lifestyle management, diet, disease monitoring, and medication adherence is essential in achieving desired therapeutic outcomes, preventing complications and improving those patients' Health-Related Quality of Life (HRQoL). Pharmacists are the most accessible healthcare professionals to the public and have a crucial role in optimizing treatment outcomes in patients with chronic diseases such as diabetes and hypertension. Experimental trials' demonstrating the potential roles of pharmaceutical services is scarce in the literature, particularly in developing countries of south Asia. Therefore, the investigators plan to conduct a prospective-interventional trial to determine the potential impacts of pharmacist-supervised educational intervention on the management of "Type II diabetic with comorbid hypertension" patients. Patient data will be collected using patient's clinical profile forms, General Medication adherence Scale (GMAS), Patients Satisfaction towards pharmaceutical services (PSPSQ), Health Related-KAP questionnaires. Data will be verified, stored, entered into databases, and analyzed according to the data management plan. The findings will be compared in terms of clinical and nonclinical outcome measures between the control and test groups to ascertain the conclusion.
Detailed description
Diabetics are twice as likely as non-diabetics to develop hypertension. Hypertension is a strong predictor of adverse cerebulo-vascular and cardiovascular events in people with diabetes, which increases risk of Premature micro-vascular and macro-vascular problems in patients encompassing both diseases. Therefore, strict glycemic and blood pressure control is essential to subdue complication and prevent dreadful cardiovascular events such as stroke, Ischemia and myocardial infarction. Participants with both chronic diseases may have lower HRQoL due to increased susceptibility towards cardiovascular comorbidities. Adherence to medication is equally crucial for treatment success. Pharmacist in collaboration with other healthcare members, could play a vital role in the care of patients and optimizing treatment outcomes in patients with chronic diseases .
Chronic disease management is of particular interest to clinical pharmacist since most intervention requires long-term prescription medication use. The international pharmaceutical federation (FIP) and world health organization (WHO) have implored pharmacists to support people with chronic disease through their expanded role that includes "pharmaceutical care." In Nepal, Clinical Pharmacy practice is still in early infancy, though few studies have shown encouraging impacts of pharmaceutical care services. Similarly, there is a significant gap in the literature in this region addressing the impact of pharmacist-supervised educational intervention on both clinical and nonclinical outcomes measures, primarily focusing on co-morbid Diabetes- Hypertensive patients. Therefore, these studies are intended to recap and fill that gap area and add new and valuable insight to the available literature.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Usual Standard Care) | No intervention | –Control group patient will undergo routine care by their physician and nurses. However, the investigator will only provide basic counseling regarding drug prescribed during discharge to the patients. In another term "Usual care" will be provided to the patients |
| Intervention Group (Clinical Pharmacist-led educational Intervention) | Other | Other: Clinical Pharmacist-Led Educational InterventionIn addition to routine care by physician and nurses, Patients in interventional group will receive two consecutive face to face interview and counseling of 20-40 minutes during the baseline period and the first follow-up period at 3-month by clinical pharmacist. Teaching and counseling session involves information on various non-pharmacological and pharmacological disease management strategies. |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients aged 40 to 68 years.
- Clinically diagnosed with type II diabetes mellitus with hypertension as co-morbidity.
- Minimum one year of the medical history of diabetic and hypertension.
- Minimum 6 months on antidiabetic as well as antihypertensive medication therapy.
- Patients willing to participate in the study and those providing written informed consent for participation.
Key exclusion criteria (5 listed)
- Patients with Type I diabetes mellitus, Diabetic insipidus, Gestational diabetes or other forms of diabetes.
- Presence of other chronic disease co-morbidity other than hypertension and diabetes complications.
- Mentally incompetent patients, Pregnant, critically ill patients (requiring hospital admission).
- Patients have tuberculosis, Corona virus, and other highly communicable diseases.
- Those patients not willing to performing routine follow-up visit.
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 |
|---|---|---|
| Clinical Pharmacist-Led Educational InterventionNon Pharmacological management strategies include information related to life style modification, healthy dietary habits, physical activity and stress management techniques. In contrast, pharmacological educational intervention involves disease -related information ( diabetes/hypertension sign and symptoms, risk factor, complications, self-monitoring of blood pressure/glucose, symptoms and management of hypoglycemia/hypotension etc. ) and drug related information ( prescribed drug name, indication, contraindication, adverse effects etc.) as well as importance of adherence to prescribed medication and strategies to minimize DRPs issues. These teaching sessions will be carried out with the help of verbal communication, audio visual demonstration (including charts,pictorial etc) and information leaflets. Furthermore, a copy of educational package would be given to each participant for reference and guidance. | Other | Intervention Group (Clinical Pharmacist-led educational Intervention) |
Primary outcome
Change in blood pressure
Time frame: baseline, follow up at 3 months and 6 months respectively
Assessed with measurement of Systolic and diastolic blood pressure in mmHg using sphygmomanometer
Change in blood glycemic profile
Time frame: baseline, follow up at 3 months and 6 months respectively
Assessed with measurement of Fasting Blood Sugar (FBS) and Post Prandial Blood Sugar (PPBS) in mg/dl.
change in glycosylated hemoglobin (HbA1C) level
Time frame: baseline, follow up at 3 months and 6 months respectively
assessed from patients glycosylated hemoglobin (HbA1C) level test, measured in percent (%)
Impact of Intervention in Patients Medication Adherence
Time frame: baseline, follow up at 3 months and 6 months respectively
It will be measured using translated and validated Nepalese version of the 11-item Novel general medication adherence Scale (GMAS) questionnaire divided into three categories based on a four-level Likert scale. GMAS tools provide a wide range of components, including disease and medication burden, patient behavior both intentional and unintentional, and cost-related burden associated with non-adherence. Higher Scores better the outcomes, measured within categories and overall adherence level.
Compare patients perceived Satisfaction of pharmaceutical care services
Time frame: baseline, follow up at 3 months and 6 months respectively
This will be assessed by using Nepali version of Patients Perceived satisfaction of Pharmacist care (PSPSQ. 2 ) questionnaire. This tool comprises 20 items questionnaire divided into three dimensions based on a four-point Likert scale. Dimensions include quality of care, pharmacist-patient relationships, and overall satisfaction. Higher scores represent better outcomes, measured within domains and overall satisfaction levels.
Change in Health related Quality of Life
Time frame: baseline, follow up at 3 months and 6 months respectively
Translated Nepali version of Euro 5 D 5 L questionnaire measures will be used to measure patients' health-related quality of life (HRQoL). This questionnaire created by the European Quality of Life Group (EuroQol Group) measure HRQoL in five dimension Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels to describe the severity: no problem, slight problem, moderate problem, severe problem, and unable (very severe). The outcomes will be measured in the overall health utility index value. The index value ranges from -1 to 1 (0 indicates death, <0 indicates worse than death, and 1 indicates full health)
2 secondary outcomes
Change in routine clinical laboratory parameters of patients Lipid Profile test.
Time frame: baseline, follow up at 3 months and 6 months respectively
Change in Patients health related Knowledge, Attitude and Practice
Time frame: baseline, follow up at 3 months and 6 months respectively
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 Feb 2025.
- Background: PubMed 30863660Naqvi AA, Hassali MA, Jahangir A, Nadir MN, Kachela B. Translation and validation of the English version of the general medication adherence scale (GMAS) in patients with chronic illnesses. J Drug Assess. 2019 Feb 6;8(1):36-42. doi: 10.1080/21556660.2019.1579729. eCollection 2019.
- Background: PubMed 34475753Shrestha R, Sapkota B, Khatiwada AP, Shrestha S, Khanal S, Kc B, Paudyal V. Translation, Cultural Adaptation and Validation of General Medication Adherence Scale (GMAS) into the Nepalese Language. Patient Prefer Adherence. 2021 Aug 27;15:1873-1885. doi: 10.2147/PPA.S320866. eCollection 2021.
- Background: PubMed 25481330Sakharkar P, Bounthavong M, Hirsch JD, Morello CM, Chen TC, Law AV. Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services. Res Social Adm Pharm. 2015 Jul-Aug;11(4):487-98. doi: 10.1016/j.sapharm.2014.10.006. Epub 2014 Oct 22.
- Background: PubMed 33035243Shrestha S, Sapkota B, Thapa S, K C B, Khanal S. Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings. PLoS One. 2020 Oct 9;15(10):e0240488. doi: 10.1371/journal.pone.0240488. eCollection 2020.
- 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.
Prasanna Dahal, PharmD principal investigator
Chettinad Academy of Research and Education (Deemed to be University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist-Led Educational Intervention in people with Type 2 Diabetes and Hypertension, run by Chettinad Academy of Research and Education (Deemed to be University) at 1 site in Nepal.
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 5 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 12 Feb 2025. 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 Nepal. 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 in blood pressure (time frame: baseline, follow up at 3 months and 6 months respectively). The study lists 6 primary outcomes in all. 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 NCT05707481, which also lists 4 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 12 Feb 2025.