Non-Alcoholic Fatty Liver DiseaseNCT06596382
Tocotrienol as a Treatment for Non-alcoholic Fatty Liver Disease
A study testing Tocotrienol rich-vitamin E in people with Non-Alcoholic Fatty Liver Disease, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Vitamin E's potential in treating non-alcoholic fatty liver disease (NAFLD) is attributed to its antioxidant properties. While tocopherols have shown significant results in NAFLD management, the powerful properties of tocotrienols, another form of saturated vitamin E, remain understudied. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Tocotrienol rich-vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Oct 2020to 30 Jun 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of NAFLD is confirmed by the presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score from FibroScan® of >263 dB/m
- Raised ALT level (above the upper limit of normal): >35 U/L for males and >25 U/L for females
Who cannot join
- Evidence of other chronic liver diseases (e.g. Hepatitis B, C infections, autoimmune hepatic disorders)
- Evidence of acute disorders affecting the liver (e.g. drug-induced liver injury, non-Hepatitis B, C viral infection)
- Biliary disease
- Liver cancer - primary hepatocellular carcinoma or liver metastasis
- Evidence of liver cirrhosis
- Alcohol intake of >20 g/day for males and 10 g/day for females
Show all 10Show fewer
- Use of steatogenic medications within the past three months (e.g. systemic steroids, methotrexate)
- History of bariatric surgery
- Intake of antibiotics and/or probiotic supplements within two months prior to the study
- Intake of a lipid-lowering agent (statin) within a month prior to the study.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
About this study
Official title: A Randomised Double-blind Controlled Trial on Tocotrienol as a Treatment for Non-alcoholic Fatty Liver
Vitamin E's potential in treating non-alcoholic fatty liver disease (NAFLD) is attributed to its antioxidant properties. While tocopherols have shown significant results in NAFLD management, the powerful properties of tocotrienols, another form of saturated vitamin E, remain understudied. This research aims to assess tocotrienol's effectiveness in treating NAFLD, expanding our understanding of its therapeutic benefits.
Read the detailed description
This is a randomized double-blinded placebo-controlled trial targeted toward patients being diagnosed with non-alcoholic fatty liver disease. Patients will be screened and identified from the gastroenterology and hepatology clinic in Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. The study expects a total of 264 participants to take part in this four-arm investigation, requiring a sample size of 66 for each arm, with an alpha probability of 0.05 and a power of 0.8.
The selection of participants is based on established criteria. The criteria include being 18 years and above, having a high CAP score from FibroScan, and elevated ALT levels. Patients with chronic liver diseases, acute disorders affecting the liver, biliary disease, cancer, and liver cirrhosis were excluded. Alcohol intake was monitored, with a minimum amount set. Any history of bariatric surgery deemed participants unfit for the study. Additionally, participants must be free from the use of steatogenic medication, antibiotics/probiotics, and lipid-lowering agents within one to three months before the study.
After the screening process, participants were assigned to two groups based on metabolic syndrome presence. Within each group, individuals were randomly selected to receive either a vitamin E supplement or a placebo. Each vitamin E capsule contains a certain amount of dosage with a safe concentration for consumption. The metabolic group received 100mg of tocotrienol rich-vitamin E, while the non-metabolic group received 50mg of tocotrienol rich-vitamin E. Meanwhile, each placebo capsule does not contain any vitamin E, which supplied to both group.
Several analyses were performed before and after vitamin E/placebo administration. Firstly, anthropometric data was gathered for their physical measurement. Besides that, FibroScan and LiverFast analysis to examine the liver health condition. Other than that,molecular approach was also conducted to assess the mRNA gene expression level on the selected cytokines such as TNFα, IFNγ, IL-6, and IL-8 and also observe the DNA damage of the cells using Comet Assay. Additionally, biochemical blood testing was tested on 10 parameters to measure its concentration levels within the body. Lastly, each participant was required to answer questionnaires for evaluation on physical activity levels via IPAQ and their dietary patterns through the FFQ
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Tocotrienol rich-vitamin E, Placebo
- Keywords
- Tocotrienol, Vitamin E, Fatty Liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol rich-vitamin EDietary supplement
Two dosage are available which are 100 mg for NAFLD patient with underlying metabolic syndrome meanwhile 50mg for NALFD patient without metabolic syndrome
PlaceboDietary supplement
Replicate for tocotrienol rich-vitamin E without any active ingredients
| Study group | Role | What they receive |
|---|---|---|
| NAFLD with metabolic syndrome; intervention with tocotrienol rich-vitamin E | Active comparator | 66 patient diagnosed with NALFD and associated with metabolic syndrome were given 100mg of tocotrienol rich-vitamin E for six months Receives: Dietary Supplement: Tocotrienol rich-vitamin E |
| NAFLD without metabolic syndrome; intervention with tocotrienol rich-vitamin E | Active comparator | 66 patient diagnosed with NALFD without being associated with metabolic syndrome were given 50mg of tocotrienol rich-vitamin E for six months Receives: Dietary Supplement: Tocotrienol rich-vitamin E |
| NAFLD with metabolic syndrome; intervention with placebo | Placebo comparator | 66 patient diagnosed with NALFD and associated with metabolic syndrome were given placebo for six months Receives: Dietary Supplement: Placebo |
| NAFLD without metabolic syndrome; intervention with placebo | Placebo comparator | 66 patient diagnosed with NALFD without being associated with metabolic syndrome were given placebo for six months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat percentage before and after intervention in percentage
The measurement were taken using TANITA machine for fat percentage (%) before and after taking vitamin E/Placebo
Measured: 6 months
Fat free mass in kilogram before and after intervention
The measurement were taken using TANITA machine for fat mass, and fat free mass in kilogram, before and after taking vitamin E or Placebo
Measured: 6 months
Basal metabolic rate in kJ before and after intervention
The measurement were taken using TANITA machine for BMR (kJ) before and after taking vitamin E or Placebo
Measured: 6 months
Body Mass Index in kg/m2 before and after intervention
The measurement were taken using TANITA machine for height and weight and will be combined and reported as body mass index (BMI) in kg/m2 before and after taking vitamin E or Placebo
Measured: 6 months
Visceral fat before and after intervention
The measurement were taken using TANITA machine for visceral fat before and after taking vitamin E or Placebo
Measured: 6 months
Liver stiffness based on CAP score before and after intervention
Liver stiffness in the liver was measured using transient elastography technique via FibroScan device, where the evaluation is based on controlled attenuated parameter (CAP) score before and after taking vitamin E/Placebo. CAP score of > 263 indicates fatty liver. The highest score is 1.0. A higher score denotes a worse outcome.
Measured: 6 months
Fatty changes in kPA before and after intervention
Fatty changes in the liver was measured using transient elastography technique via FibroScan device where the evaluation is based on kPA before and after taking vitamin E/Placebo.
Measured: 6 months
Fibrosis via Fibrotest before and after intervention
Blood sample were taken from the patient to determine the degree of liver damage through FibroTest (Fibrosis) based on 10 biomarkers before and after taking vitamin E/Placebo.
Measured: 6 months
Inflammation ActiTest before and after intervention
Blood sample were taken from the patient to determine the degree of liver damage through ActiTest (Inflammation) based on 10 biomarkers before and after taking vitamin E/Placebo.
Measured: 6 months
Steatosis via SteatoTest before and after intervention
Blood sample were taken from the patient to determine the degree of liver damage through SteatoTest (Steatosis) based on 10 biomarkers before and after taking vitamin E/Placebo.
Measured: 6 months
mRNA gene expression level of inflammatory cytokines before and after intervention
Blood sample were taken and extracted for the qualitative determination of mRNA gene expression level of the cytokines (TNFα, IFNγ, IL-6, IL-8) in fold change including housekeeping gene using qPCR method before and after taking vitamin E or Placebo.
Measured: 6 months
DNA damage analysis via Comet assay before and after intervention
Comet assay were conducted to access the DNA damage in the eukaryotic cells via blood sample before and after taking vitamin E/Placebo
Measured: 6 months
Secondary outcomes (7)
Plasma Protein
Protein found in blood which are Alpha-2-macroglobulin, haptoglobin, and apolipoprotein A1 analyzed before and after taking vitamin E/Placebo.
Measured: 6 months
Liver enzymes
Liver enzymes found in blood which are gamma-glutamyl transferase (GGT), alanine transferase (ALT), aspartate aminotransferase (AST) were analyzed before and after taking vitamin E/Placebo.
Measured: 6 months
Triglyceride levels
Triglyceride levels (measured in mg/dL or mmol/L) were analyzed before and after treatment with vitamin E or placebo. Changes in triglyceride levels will be compared to assess the intervention's impact on lipid levels.
Measured: 6 months
Fasting glucose levels
Fasting glucose levels (measured in mg/dL or mmol/L) were analyzed before and after treatment with vitamin E or placebo. Changes in glucose levels will be compared to assess the impact on blood sugar regulation.
Measured: 6 months
Total cholesterol levels
Total cholesterol levels (measured in mg/dL or mmol/L) were analyzed before and after treatment with vitamin E or placebo. Changes in cholesterol levels will be compared to evaluate the effect on lipid metabolism.
Measured: 6 months
International Physical Activity Questionnaire (IPAQ)
Questionnaires related to the physical activity was filled by the patient before and after taking vitamin E or Placebo. The total weekly minutes for each domain will be added up to total the participants' estimated overall physical activity. A longer duration indicates a better outcome.
Measured: 6 months
Food Frequency Questionnaire (FFQ)
Questionnaires related to the food frequency intake was filled by the patient before and after taking vitamin E/Placebo. The food frequency questionnaires give valuable insights into dietary habits by giving out the percentage intake of protein, carbohydrates and total fats. A higher percentage of protein indicates a good diet intake while higher percentages of carbohydrates and total fats indicate a bad diet intake.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Oct 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- A randomized double-blinded placebo-controlled trial was performed toward patients diagnosed with NALFD with several established inclusion and exclusion criteria of study. Two main groups were formed to separate the patient into metabolic syndrome and non-metabolic group. In these groups, it will further divided into two groups where the administration of tocotrienol rich-vitamin E and placebo were given in random manner. Each participant will consume the vitamin/placebo daily for one capsule in the duration of six months. Various assessments was conducted before and after taking the vitamin E/placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596382
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2020-190
- Other IDs
- FF-2020-180
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are bound to the Institutional Review Board Universiti Kebangsaan Malaysia Medical Research Ethics Committee rules and regulations where recruited patients identity and data are kept confidential and will only be allowed to access by the research team.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Controlled Trial on Tocotrienol as a Treatment for Non-alcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT06596382
- Acronym / sponsor ID
- UKM PPI/111/8/JEP-2020-190
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Tocotrienol, Vitamin E, Fatty Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin E's potential in treating non-alcoholic fatty liver disease (NAFLD) is attributed to its antioxidant properties. While tocopherols have shown significant results in NAFLD management, the powerful properties of tocotrienols, another form of saturated vitamin E, remain understudied. This research aims to assess tocotrienol's effectiveness in treating NAFLD, expanding our understanding of its therapeutic benefits.
Detailed description
This is a randomized double-blinded placebo-controlled trial targeted toward patients being diagnosed with non-alcoholic fatty liver disease. Patients will be screened and identified from the gastroenterology and hepatology clinic in Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. The study expects a total of 264 participants to take part in this four-arm investigation, requiring a sample size of 66 for each arm, with an alpha probability of 0.05 and a power of 0.8.
The selection of participants is based on established criteria. The criteria include being 18 years and above, having a high CAP score from FibroScan, and elevated ALT levels. Patients with chronic liver diseases, acute disorders affecting the liver, biliary disease, cancer, and liver cirrhosis were excluded. Alcohol intake was monitored, with a minimum amount set. Any history of bariatric surgery deemed participants unfit for the study. Additionally, participants must be free from the use of steatogenic medication, antibiotics/probiotics, and lipid-lowering agents within one to three months before the study.
After the screening process, participants were assigned to two groups based on metabolic syndrome presence. Within each group, individuals were randomly selected to receive either a vitamin E supplement or a placebo. Each vitamin E capsule contains a certain amount of dosage with a safe concentration for consumption. The metabolic group received 100mg of tocotrienol rich-vitamin E, while the non-metabolic group received 50mg of tocotrienol rich-vitamin E. Meanwhile, each placebo capsule does not contain any vitamin E, which supplied to both group.
Several analyses were performed before and after vitamin E/placebo administration. Firstly, anthropometric data was gathered for their physical measurement. Besides that, FibroScan and LiverFast analysis to examine the liver health condition. Other than that,molecular approach was also conducted to assess the mRNA gene expression level on the selected cytokines such as TNFα, IFNγ, IL-6, and IL-8 and also observe the DNA damage of the cells using Comet Assay. Additionally, biochemical blood testing was tested on 10 parameters to measure its concentration levels within the body. Lastly, each participant was required to answer questionnaires for evaluation on physical activity levels via IPAQ and their dietary patterns through the FFQ
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- A randomized double-blinded placebo-controlled trial was performed toward patients diagnosed with NALFD with several established inclusion and exclusion criteria of study. Two main groups were formed to separate the patient into metabolic syndrome and non-metabolic group. In these groups, it will further divided into two groups where the administration of tocotrienol rich-vitamin E and placebo were given in random manner. Each participant will consume the vitamin/placebo daily for one capsule in the duration of six months. Various assessments was conducted before and after taking the vitamin E/placebo.
| Arm | Type | Receives |
|---|---|---|
| NAFLD with metabolic syndrome; intervention with tocotrienol rich-vitamin E | Active comparator | Dietary Supplement: Tocotrienol rich-vitamin E66 patient diagnosed with NALFD and associated with metabolic syndrome were given 100mg of tocotrienol rich-vitamin E for six months |
| NAFLD without metabolic syndrome; intervention with tocotrienol rich-vitamin E | Active comparator | Dietary Supplement: Tocotrienol rich-vitamin E66 patient diagnosed with NALFD without being associated with metabolic syndrome were given 50mg of tocotrienol rich-vitamin E for six months |
| NAFLD with metabolic syndrome; intervention with placebo | Placebo comparator | Dietary Supplement: Placebo66 patient diagnosed with NALFD and associated with metabolic syndrome were given placebo for six months |
| NAFLD without metabolic syndrome; intervention with placebo | Placebo comparator | Dietary Supplement: Placebo66 patient diagnosed with NALFD without being associated with metabolic syndrome were given placebo for six months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of NAFLD is confirmed by the presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score from FibroScan® of >263 dB/m
- Raised ALT level (above the upper limit of normal): >35 U/L for males and >25 U/L for females
Key exclusion criteria (10 listed)
- Evidence of other chronic liver diseases (e.g. Hepatitis B, C infections, autoimmune hepatic disorders)
- Evidence of acute disorders affecting the liver (e.g. drug-induced liver injury, non-Hepatitis B, C viral infection)
- Biliary disease
- Liver cancer - primary hepatocellular carcinoma or liver metastasis
- Evidence of liver cirrhosis
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 |
|---|---|---|
| Tocotrienol rich-vitamin ETwo dosage are available which are 100 mg for NAFLD patient with underlying metabolic syndrome meanwhile 50mg for NALFD patient without metabolic syndrome | Dietary supplement | NAFLD with metabolic syndrome; intervention with tocotrienol rich-vitamin E, NAFLD without metabolic syndrome; intervention with tocotrienol rich-vitamin E |
| PlaceboReplicate for tocotrienol rich-vitamin E without any active ingredients | Dietary supplement | NAFLD with metabolic syndrome; intervention with placebo, NAFLD without metabolic syndrome; intervention with placebo |
Primary outcome
Fat percentage before and after intervention in percentage
Time frame: 6 months
The measurement were taken using TANITA machine for fat percentage (%) before and after taking vitamin E/Placebo
Fat free mass in kilogram before and after intervention
Time frame: 6 months
The measurement were taken using TANITA machine for fat mass, and fat free mass in kilogram, before and after taking vitamin E or Placebo
Basal metabolic rate in kJ before and after intervention
Time frame: 6 months
The measurement were taken using TANITA machine for BMR (kJ) before and after taking vitamin E or Placebo
Body Mass Index in kg/m2 before and after intervention
Time frame: 6 months
The measurement were taken using TANITA machine for height and weight and will be combined and reported as body mass index (BMI) in kg/m2 before and after taking vitamin E or Placebo
Visceral fat before and after intervention
Time frame: 6 months
The measurement were taken using TANITA machine for visceral fat before and after taking vitamin E or Placebo
Liver stiffness based on CAP score before and after intervention
Time frame: 6 months
Liver stiffness in the liver was measured using transient elastography technique via FibroScan device, where the evaluation is based on controlled attenuated parameter (CAP) score before and after taking vitamin E/Placebo. CAP score of > 263 indicates fatty liver. The highest score is 1.0. A higher score denotes a worse outcome.
Fatty changes in kPA before and after intervention
Time frame: 6 months
Fatty changes in the liver was measured using transient elastography technique via FibroScan device where the evaluation is based on kPA before and after taking vitamin E/Placebo.
Fibrosis via Fibrotest before and after intervention
Time frame: 6 months
Blood sample were taken from the patient to determine the degree of liver damage through FibroTest (Fibrosis) based on 10 biomarkers before and after taking vitamin E/Placebo.
Inflammation ActiTest before and after intervention
Time frame: 6 months
Blood sample were taken from the patient to determine the degree of liver damage through ActiTest (Inflammation) based on 10 biomarkers before and after taking vitamin E/Placebo.
Steatosis via SteatoTest before and after intervention
Time frame: 6 months
Blood sample were taken from the patient to determine the degree of liver damage through SteatoTest (Steatosis) based on 10 biomarkers before and after taking vitamin E/Placebo.
mRNA gene expression level of inflammatory cytokines before and after intervention
Time frame: 6 months
Blood sample were taken and extracted for the qualitative determination of mRNA gene expression level of the cytokines (TNFα, IFNγ, IL-6, IL-8) in fold change including housekeeping gene using qPCR method before and after taking vitamin E or Placebo.
DNA damage analysis via Comet assay before and after intervention
Time frame: 6 months
Comet assay were conducted to access the DNA damage in the eukaryotic cells via blood sample before and after taking vitamin E/Placebo
7 secondary outcomes
Plasma Protein
Time frame: 6 months
Liver enzymes
Time frame: 6 months
Triglyceride levels
Time frame: 6 months
Fasting glucose levels
Time frame: 6 months
Total cholesterol levels
Time frame: 6 months
International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
Food Frequency Questionnaire (FFQ)
Time frame: 6 months
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 22 Nov 2024.
- Individual participant dataSharing planned: No. The investigators are bound to the Institutional Review Board Universiti Kebangsaan Malaysia Medical Research Ethics Committee rules and regulations where recruited patients identity and data are kept confidential and will only be allowed to access by the research team.
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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 Tocotrienol rich-vitamin E in people with Non-Alcoholic Fatty Liver Disease, run by National University of Malaysia at 1 site in Malaysia.
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 2 inclusion and 10 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 22 Nov 2024. 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 Malaysia. 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?
Fat percentage before and after intervention in percentage (time frame: 6 months). The study lists 12 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 22 Nov 2024.