Chronic Kidney Disease (CKD)NCT04094831
Community-based Screening of Chronic Kidney Disease (CKD) and Measure the Impact of Health Education
A study testing Health education in people with Chronic Kidney Disease (CKD), run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Background: Chronic kidney disease (CKD) is a global public health concern. Currently 10-16% adults are affected with CKD. Adult individuals from low- and middle-income countries are at higher risk of developing CKD and End stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2020to 30 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All diagnosed CKD patients with stage 1-3 from Study 1
- Who gave written informed consent to participate in the study.
- At least 1-5 years of schooling
- Using mobile phone at house
Who cannot join
- CKD participants with stage 4-5.
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-based Screening to Determine the Prevalence, Current Health and Nutritional Status of Individuals With Chronic Kidney Disease (CKD) and Measure the Outcome of Health Education to Enhance Knowledge, Awareness and Risk Reduction Strategies in Mirzapur Sub-district, Bangladesh
Background: Chronic kidney disease (CKD) is a global public health concern. Currently 10-16% adults are affected with CKD. Adult individuals from low- and middle-income countries are at higher risk of developing CKD and End stage renal disease (ESRD). Preventive and risk reduction measures have potentials to reduce the disease progression; however, population in general from developing countries are yet to be properly aware about all these strategies that may help reduction in progression of CKD.
Knowledge gap: Specific studies are grossly lacking about CKD prevalence, its associated factors, and the knowledge and awareness about preventive and risk reduction strategies among adults with CKD in rural and peri-urban Bangladesh. Moreover, knowledge gaps still exist about the role of Protein Energy Wasting (PEW), physical activities, medication adherence, dietary practice, salt restriction behaviours, etc. in influencing progression of CKD.
Read more
Relevance: It has become essential to know more about the burden of CKD, its associated factors, current knowledge and awareness about healthy practices related to CKD and formulation of appropriate preventive and risk reduction strategies that will have potentials in reducing the progression of CKD in rural and peri-urban Bangladesh. The health education program for population in general and CKD individuals in particular will help in achieving meaningful results.
Hypothesis:Health education about CKD and its preventive and risk reduction strategies will enhance the knowledge, awareness, and motivation for healthy practices among the residents of demographic surveillance system (DSS) area with CKD.
Objectives:
To implement and evaluate impact of a health education program in order to enhance knowledge, awareness, and motivation about healthy practices among rural adults suffering from CKD.
Methods:
A community based randomized controlled effectiveness trial (RCT) Study site: DSS area of Mirzapur sub-district under Tangail, Bangladesh.
Outcome measures:
Primary outcomes: Changes of scores of Australian CKD knowledge questionnaire Secondary outcomes: Awareness, Quality of life (QOL), and healthy practices leading to maintenance of blood pressure, blood sugar and body weight within normal ranges by the adult CKD individuals.
Read the detailed description
This would be a community-based randomized controlled trial (RCT) among the individuals diagnosed as having CKD with stage 1-3 who agreed to participate.
Registration/Enrolment of participants:
Community health workers (CHWs) will perform home -visits to obtain written informed consent, perform physical examination, and interview the respondents administering field tested questionnaires.
Interviewing by administering a structured questionnaire: if changed from Study 1: Age, gender, marital status, occupation, educational background, income/month, participant's current medical history including medication use, past medical history, sleeping hours, and family history (3rd generation) including current and immediate past medical history.
Physical examinations will be performed to measure: Blood pressure, pulse, height, weight, waist circumference, hip circumference, triceps skin fold (TSF), mid-upper arm circumference (MUAC), body mass index (BMI) and mid-arm muscle circumference (MAMC).
Blood sample (at hospital) Serum creatinine (estimate eGFR), serum albumin, Hb%, FBS, HbA1C, lipid profile (TP, HDL-c, LDL-c, triglyceride, and ratio: estimate non-HDL), serum uric acid, Urea (BUN).
Urine specimens (at hospital) Albumin to creatinine ratio (ACR), urine RME, urine Na (calculate sodium intake)
Questionnaires/Interviewing :
Chronic Kidney Disease Knowledge Questionnaire (24 questions) Awareness question (1 question) QOL (5 EURO-QOL questionnaire) Randomisation: A simple randomization (1:1) either intervention group or control group will be undertaken following a computer-generated random number sequence. An experienced statistician, who will not be involved in the study in any way, will prepare the randomization table and list of study participants' numbers with corresponding intervention allocations for CKD individual in serially numbered sealed envelopes according to randomization schedule to correspond to the serial number of the CKD individuals. These envelopes will be kept in an office locker. Allocation will be concealed in identical sealed envelopes that will only be opened when the study participant is ready for enrolment. This will take place after a CKD individual has been enrolled in the study following obtaining voluntarily informed written consent and assigning a study number. Necessary attempts will be made to keep CHWs unaware about case/control status of the participants. Similar approach will also be followed at the time of data analysis.
Study contents:
The intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition, education through mHealth will be provided by Short Message Service (SMS) during the study period. The contents of the SMS are: 1). Reduce salt intake; 2) Do exercise and take medicine regularly; 3). Control blood pressure (if hypertensive) and blood sugar (if diabetic); and 4) Avoid painkiller and smoking will be sent to the participants using mobile phone once a week for first 2.5 months and once a 2-week for next 3 months.
The CKD knowledge questionnaire consisted a total of 24 questions with the multiple-choice options 'true', 'false' and 'I don't know'. The validated questionnaire will be adapted according to Bangldesh context and will be pre-tested before starting the study. The quality of life will be assessed using an adapted and validated Bangla version of the 5 EURO-QOL questionnaire. It has five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Sample size calculation:
Assuming that proportion of knowledge and awareness among CKD patients at baseline as 30%; and at the end of six months it will increase to 70% (intervention group) and 40% (control group). Therefore, considering 90% power and 20% loss to follow-up the total sample size will be 136 (68 in each group).
Data analysis:
The descriptive statistics will be expressed as frequency, mean, median, cross tabulation, and standard deviation. Chi-square test, t-test or Mann-Whitney U-test will be performed to see the differences between intervention group and control group at baseline, 3 and 6 months. Multiple comparisons will be performed by ANOVA test for evaluation of the outcome variables such as CKD knowledge and awareness questionnaire and QOL at baseline, 3 and 6 months. Data will be analyzed using SPSS ver. 22.0 (IBM Co., Armonk, NY) and the significance level will be set at the level of p < 5%.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Health education
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
The intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition,Basic health education information about CKD is included in the contents to help patients gain knowledge, awareness, and improve their behaviors. Discussion on basic kidney diseases, risk factors, and preventive measures of CKD is performing by CHWs over a mobile phone call to the study patients. The patients have the liberty to discuss their health-related issues with the CHWs over a period of 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Intervention group (Health education through CKD campaign and mHealth) technology Receives: Other: Health education |
| Control | Active comparator | No intervention Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Kidney Disease Knowledge Questionnaire
The questionnaire consisted a total of 24 questions with the multiple-choice options 'True', 'False' and 'I don't know'. Correct responses were given a score of 1 and incorrect responses were given a score of 0. The option 'I don't know' was considered as lack of knowledge and given a score of 0.
Score <50% considered as poor. The questionnaire consisted a total of 24 questions with the multiple-choice options 'True', 'False' and 'I don't know'. Correct responses were given a score of 1 and incorrect responses were given a score of 0. The option 'I don't know' was considered as lack of knowledge and given a score of 0.
Score <50% considered as poor.
Measured: 6 months after the intervention
Secondary outcomes (1)
EURO- Quality of Life questionnaire (5 EURO-QOL questionnaire)
This questionnaire based on 5 Dimensions, five-level version questionnaire. This scale is numbered from 0 to 100. 100 mean the best health you can imagine.
Measured: at 3 months and 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jul 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Hiroshima University, Child Health Research Foundation, Bangladesh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094831
- Sponsor's protocol ID
- PR-19081
- Status last verified
- Jan 2021
- First submitted
- 17 Sep 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarker MHR, Moriyama M, Rashid HU, Rahman MM, Chisti MJ, Das SK, Saha SK, Arifeen SE, Ahmed T, Faruque ASG. Chronic Kidney Disease Awareness Campaign and Mobile Health Education to Improve Knowledge, Quality of Life, and Motivation for a Healthy Lifestyle Among Patients With Chronic Kidney Disease in Bangladesh: Randomized Controlled Trial. J Med Internet Res. 2022 Aug 11;24(8):e37314. doi: 10.2196/37314.
PubMed 35969429Sarker MHR, Moriyama M, Rashid HU, Rahman MM, Chisti MJ, Das SK, Jahan Y, Saha SK, Arifeen SE, Ahmed T, Faruque ASG. Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 19;10(11):e30191. doi: 10.2196/30191.
PubMed 34806998
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Screening to Determine the Prevalence, Current Health and Nutritional Status of Individuals With Chronic Kidney Disease (CKD) and Measure the Outcome of Health Education to Enhance Knowledge, Awareness and Risk Reduction Strategies in Mirzapur Sub-district, Bangladesh
- ClinicalTrials.gov ID
- NCT04094831
- Acronym / sponsor ID
- PR-19081
- Conditions
- Chronic Kidney Disease (CKD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Hiroshima University, Child Health Research Foundation, Bangladesh
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 19 Sep 2019 (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.
Background: Chronic kidney disease (CKD) is a global public health concern. Currently 10-16% adults are affected with CKD. Adult individuals from low- and middle-income countries are at higher risk of developing CKD and End stage renal disease (ESRD). Preventive and risk reduction measures have potentials to reduce the disease progression; however, population in general from developing countries are yet to be properly aware about all these strategies that may help reduction in progression of CKD.
Knowledge gap: Specific studies are grossly lacking about CKD prevalence, its associated factors, and the knowledge and awareness about preventive and risk reduction strategies among adults with CKD in rural and peri-urban Bangladesh. Moreover, knowledge gaps still exist about the role of Protein Energy Wasting (PEW), physical activities, medication adherence, dietary practice, salt restriction behaviours, etc. in influencing progression of CKD.
Relevance: It has become essential to know more about the burden of CKD, its associated factors, current knowledge and awareness about healthy practices related to CKD and formulation of appropriate preventive and risk reduction strategies that will have potentials in reducing the progression of CKD in rural and peri-urban Bangladesh. The health education program for population in general and CKD individuals in particular will help in achieving meaningful results.
Hypothesis:Health education about CKD and its preventive and risk reduction strategies will enhance the knowledge, awareness, and motivation for healthy practices among the residents of demographic surveillance system (DSS) area with CKD.
Objectives:
To implement and evaluate impact of a health education program in order to enhance knowledge, awareness, and motivation about healthy practices among rural adults suffering from CKD.
Methods:
A community based randomized controlled effectiveness trial (RCT) Study site: DSS area of Mirzapur sub-district under Tangail, Bangladesh.
Outcome measures:
Primary outcomes: Changes of scores of Australian CKD knowledge questionnaire Secondary outcomes: Awareness, Quality of life (QOL), and healthy practices leading to maintenance of blood pressure, blood sugar and body weight within normal ranges by the adult CKD individuals.
Detailed description
This would be a community-based randomized controlled trial (RCT) among the individuals diagnosed as having CKD with stage 1-3 who agreed to participate.
Registration/Enrolment of participants:
Community health workers (CHWs) will perform home -visits to obtain written informed consent, perform physical examination, and interview the respondents administering field tested questionnaires.
Interviewing by administering a structured questionnaire: if changed from Study 1: Age, gender, marital status, occupation, educational background, income/month, participant's current medical history including medication use, past medical history, sleeping hours, and family history (3rd generation) including current and immediate past medical history.
Physical examinations will be performed to measure: Blood pressure, pulse, height, weight, waist circumference, hip circumference, triceps skin fold (TSF), mid-upper arm circumference (MUAC), body mass index (BMI) and mid-arm muscle circumference (MAMC).
Blood sample (at hospital) Serum creatinine (estimate eGFR), serum albumin, Hb%, FBS, HbA1C, lipid profile (TP, HDL-c, LDL-c, triglyceride, and ratio: estimate non-HDL), serum uric acid, Urea (BUN).
Urine specimens (at hospital) Albumin to creatinine ratio (ACR), urine RME, urine Na (calculate sodium intake)
Questionnaires/Interviewing :
Chronic Kidney Disease Knowledge Questionnaire (24 questions) Awareness question (1 question) QOL (5 EURO-QOL questionnaire) Randomisation: A simple randomization (1:1) either intervention group or control group will be undertaken following a computer-generated random number sequence. An experienced statistician, who will not be involved in the study in any way, will prepare the randomization table and list of study participants' numbers with corresponding intervention allocations for CKD individual in serially numbered sealed envelopes according to randomization schedule to correspond to the serial number of the CKD individuals. These envelopes will be kept in an office locker. Allocation will be concealed in identical sealed envelopes that will only be opened when the study participant is ready for enrolment. This will take place after a CKD individual has been enrolled in the study following obtaining voluntarily informed written consent and assigning a study number. Necessary attempts will be made to keep CHWs unaware about case/control status of the participants. Similar approach will also be followed at the time of data analysis.
Study contents:
The intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition, education through mHealth will be provided by Short Message Service (SMS) during the study period. The contents of the SMS are: 1). Reduce salt intake; 2) Do exercise and take medicine regularly; 3). Control blood pressure (if hypertensive) and blood sugar (if diabetic); and 4) Avoid painkiller and smoking will be sent to the participants using mobile phone once a week for first 2.5 months and once a 2-week for next 3 months.
The CKD knowledge questionnaire consisted a total of 24 questions with the multiple-choice options 'true', 'false' and 'I don't know'. The validated questionnaire will be adapted according to Bangldesh context and will be pre-tested before starting the study. The quality of life will be assessed using an adapted and validated Bangla version of the 5 EURO-QOL questionnaire. It has five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Sample size calculation:
Assuming that proportion of knowledge and awareness among CKD patients at baseline as 30%; and at the end of six months it will increase to 70% (intervention group) and 40% (control group). Therefore, considering 90% power and 20% loss to follow-up the total sample size will be 136 (68 in each group).
Data analysis:
The descriptive statistics will be expressed as frequency, mean, median, cross tabulation, and standard deviation. Chi-square test, t-test or Mann-Whitney U-test will be performed to see the differences between intervention group and control group at baseline, 3 and 6 months. Multiple comparisons will be performed by ANOVA test for evaluation of the outcome variables such as CKD knowledge and awareness questionnaire and QOL at baseline, 3 and 6 months. Data will be analyzed using SPSS ver. 22.0 (IBM Co., Armonk, NY) and the significance level will be set at the level of p < 5%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Other: Health educationIntervention group (Health education through CKD campaign and mHealth) technology |
| Control | Active comparator | Other: Health educationNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All diagnosed CKD patients with stage 1-3 from Study 1
- Who gave written informed consent to participate in the study.
- At least 1-5 years of schooling
- Using mobile phone at house
Key exclusion criteria (2 listed)
- CKD participants with stage 4-5.
- Not willing to participate in the study
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 |
|---|---|---|
| Health educationThe intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition,Basic health education information about CKD is included in the contents to help patients gain knowledge, awareness, and improve their behaviors. Discussion on basic kidney diseases, risk factors, and preventive measures of CKD is performing by CHWs over a mobile phone call to the study patients. The patients have the liberty to discuss their health-related issues with the CHWs over a period of 10 minutes | Other | Control, Intervention arm |
Primary outcome
Chronic Kidney Disease Knowledge Questionnaire
Time frame: 6 months after the intervention
The questionnaire consisted a total of 24 questions with the multiple-choice options 'True', 'False' and 'I don't know'. Correct responses were given a score of 1 and incorrect responses were given a score of 0. The option 'I don't know' was considered as lack of knowledge and given a score of 0. Score <50% considered as poor. The questionnaire consisted a total of 24 questions with the multiple-choice options 'True', 'False' and 'I don't know'. Correct responses were given a score of 1 and incorrect responses were given a score of 0. The option 'I don't know' was considered as lack of knowledge and given a score of 0. Score <50% considered as poor.
1 secondary outcome
EURO- Quality of Life questionnaire (5 EURO-QOL questionnaire)
Time frame: at 3 months and 6 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 35969429Sarker MHR, Moriyama M, Rashid HU, Rahman MM, Chisti MJ, Das SK, Saha SK, Arifeen SE, Ahmed T, Faruque ASG. Chronic Kidney Disease Awareness Campaign and Mobile Health Education to Improve Knowledge, Quality of Life, and Motivation for a Healthy Lifestyle Among Patients With Chronic Kidney Disease in Bangladesh: Randomized Controlled Trial. J Med Internet Res. 2022 Aug 11;24(8):e37314. doi: 10.2196/37314.
- Derived from this study: PubMed 34806998Sarker MHR, Moriyama M, Rashid HU, Rahman MM, Chisti MJ, Das SK, Jahan Y, Saha SK, Arifeen SE, Ahmed T, Faruque ASG. Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 19;10(11):e30191. doi: 10.2196/30191.
- 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.
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 Health education in people with Chronic Kidney Disease (CKD), run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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 Bangladesh. 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?
Results are not available in the source record.
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?
Chronic Kidney Disease Knowledge Questionnaire (time frame: 6 months after the intervention). 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 NCT04094831, which also lists 2 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 1 Oct 2021.