Constipation - FunctionalNCT05541991
Study on the Effect of Rhubarb Extract on Stool Frequency and Biological Markers of Intestinal Function in Seniors With Low Defecation
A study testing single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract and double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract in people with Constipation - Functional, run by ortis at 1 site in France.
Trial summary
Randomized double-blind clinical study versus placebo evaluating the effect of supplementation with rhubarb extract on stool frequency and biological markers of intestinal function in seniors with a low number of defecations per week Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract and double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2017to 13 Jun 2018
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presenting a number of stools ≥1 and ≤3 per week during the last month preceding the screening visit and during the last 15 days preceding the inclusion visit;
- stools often (at least 25% of defecations according to the Rome III questionnaire) hard or lumpy, according to the bristol scale, at least the last 3 months over a period of 6 months;
- not currently justifying, according to his attending physician, drug treatment;
- Giving free and informed consent to the study in writing.
Who cannot join
- Related to the patient:
- subject with signs requiring further investigations: odynophagia, involuntary weight loss >10% during the last 3 months before inclusion, persistent vomiting, hematemesis, blood in the stools, iron deficiency anemia, symptoms of obstruction, rectal bleeding, rectal prolapse …;
- subject who has not been screened for colon cancer in the past two years;
- subject participating in another therapeutic trial;
- subject with a serious general pathology and in particular renal or hepatic insufficiency, cancer, chronic pancreatitis;
- premenopausal women;
Show all 29Show fewer
- subject with known hypersensitivity to one of the constituents of the product under study;
- subject who does not have the legal or ethical capacity to contract due to an impairment of his cognitive functions;
- subject likely not to be compliant with the constraints imposed by the protocol;
- subject not benefiting from a health insurance scheme.
- Related to the disorders assessed:
- subject having taken in the 30 days preceding the screening visit or currently taking medication, food supplements and any food enriched or presented as containing substances, bacteria or yeasts likely to have an effect on the intestines and more particularly on intestinal transit, digestive comfort, gas production, the occurrence of abdominal pain. These products were also prohibited throughout the duration of the study;
- subject following a particular diet (vegetarian, vegan, high protein, etc.);
- subject on a low-calorie diet and monitored by a current or recent doctor or dietitian (< 6 weeks);
- subject undergoing medical treatment which, according to the investigator, could interfere with the evaluation of the study criteria: antibiotic, corticosteroid, anticholinergic, antidepressant, antiemetic, antihistamine, diuretic, calcium channel blocker, antiparkinsonian, antipsychotic, antacid, analgesic , NSAIDs, H2 receptor antagonist, hypnotic, sedative, iron supplement, opioid and narcotic, laxative, anti-diarrheal, anti-reflux;
- subject with an alcohol consumption greater than 3 glasses of wine per day, or two pints of beer per day, or one glass of strong alcohol per day;
- subject with a coffee consumption greater than 5 cups per day;
- smoker;
- subject with a BMI greater than 30;
- subject with constipation attributable to an organic or anatomical cause (Hirschsprung's disease, hypothyroidism, mental deficiency, psychiatric illness, neurological abnormalities, history of colon or anus operation, colorectal cancer, anemia, etc.;
- subject with a fiber intake higher than the recommended intake (more than 6 fruits and vegetables per day according to the PNNS questionnaire);
- subject with severe constipation (less than 1 bowel movement per week during the 15 days preceding the inclusion visit);
- subject with pelvic floor dysfunction;
- subject with type 1 or 2 diabetes;
- subject with a history of pathology or current disorder at the gastrointestinal level such as a duodenal ulcer, chronic colitis or a chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis), celiac disease or the syndrome irritable bowel;
- subject with a history of digestive tract surgery;
- subject having undergone surgery in the two months preceding the study;
- subject having undergone bariatric surgery;
- subject with the practice of an intense sports activity (more than 10 hours per week of intense activity as defined by the WHO).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Rhubarb Extract Supplementation on Stool Frequency and Biological Markers of Intestinal Function in Seniors With a Low Number of Defecations Per Week
Randomized double-blind clinical study versus placebo evaluating the effect of supplementation with rhubarb extract on stool frequency and biological markers of intestinal function in seniors with a low number of defecations per week
Read the detailed description
The main objective was to evaluate the effect of rhubarb extract supplementation on improving intestinal transit in subjects with a low number of defecations per week.
The secondary objectives are to assess: changes in the appearance of the stool; the evolution of the quality of life; the evolution of biological markers of intestinal function; the evolution of the intestinal microbiota; the evolution of low-grade chronic inflammatory markers; the evolution of endotoxemia; the evolution of oxidative stress; the relief experienced; subject satisfaction; the evolution of safety dosages; subject compliance.
The main efficacy criterion is the improvement in intestinal transit assessed by the frequency of stool emissions reported daily from D-14 to D 30.
The secondary endpoints correspond to the evolution of the aspect of the stools evaluated by the Bristol Stool Scale and the evolution of the quality of life evaluated by the SF-12.
They also correspond to the relief of the subjects evaluated on the PGII scale, to the tolerance of the product over the entire study period and in particular the occurrence of diarrhea and to the description of satisfaction on a Likert scale.
Regarding the biological assays, they correspond to:
- for biological markers of intestinal function to those specific to intestinal transit, i.e. active GLP-1, total GIP total PYY, PP (DPPIV substrates), Leptin, Insulin, by blood samples at D0 and D30 and that specific for permeability intestinal or claudin-3 by urine samples at D0 and D30;
- for the microbiota, analysis of bacterial taxa by PCR and metagenomics carried out on faecal samples collected on D0 and D30;
- for chronic low-grade chemokine inflammatory markers, Prostaglandins, interleukins, pro- and anti-inflammatory cytokines, ultra-sensitive CRP by blood samples at D0 and D30;
- for the measurement of endotoxaemia in the analysis of circulating LPS, TRL2 and 4 by blood samples on D0 and D30;
- for the measurement of oxidative stress to the ROS and NADPH oxidase content by blood serum samples at D0 and D30;
- for the safety assays for the lipid profile, NFS, glycaemia, kalemia, transaminases by blood samples on D0 and D30.
The studied product is a food supplement composed of a rhubarb extract standardized, characterized and optimized in order to improve these functional effects on the intestinal system (regulation of the local inflammatory system, microflora, peristalsis, etc.) at 2 different doses. The food supplement comes in the form of a film-coated tablet. The comparator product was a placebo with an appearance strictly identical to the verum and contains only excipients.
- Conditions
- Constipation - Functional
- Being tested
- single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract, placebo coated tablet, double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extractDietary supplement
coated tablet with a single dose of standardised rhubarb extract
placebo coated tabletDietary supplement
coated tablet without active principle
double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extractDietary supplement
coated tablet with a double dose of standardised rhubarb extract
| Study group | Role | What they receive |
|---|---|---|
| Single dose product | Experimental | A single dose coated tablet with standardised rhubarb extract is administrated daily in the evening during 30days Receives: Dietary Supplement: single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract |
| Double dose product | Experimental | A double dose coated tablet with standardised rhubarb extract is administrated daily in the evening during 30days Receives: Dietary Supplement: double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract |
| placebo product | Placebo comparator | A placebo coated tablet without active is administrated daily in the evening during 30days Receives: Dietary Supplement: placebo coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the number of defecations per week
The main objective was to evaluate the effect of rhubarb extract supplementation on changing intestinal transit in subjects with a low number of defecations per week.
Measured: Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)
Secondary outcomes (18)
changes in the appearance of the stool
This secondary criteria correspond to the evolution of the aspect of the stools evaluated by the Bristol Stool Scale
Measured: Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)
the change of the quality of life
the evolution of the quality of life is evaluated by the General quality of life score, not specific to a pathology (SF-12).
Measured: measured at Day -14 and Day +30 of the treatment
the evolution of biological markers of intestinal function
for biological markers of intestinal function, this corresponds to those specific specific to intestinal permeability claudin-3 by urine samples at D0 and D30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, active GLP-1
for the biological marker of intestinal function: active GLP-1, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, total GIP
for the biological marker of intestinal function: total GIP, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, total PYY
for the biological marker of intestinal function: total PYY, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, PP (DPPIV substrates)
for the biological marker of intestinal function: PP (DPPIV substrates), this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, Leptin
for the biological marker of intestinal function: total Leptin, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, Insulin
for the biological marker of intestinal function: total Insulin, this corresponds to those specific to intestinal transit, by blood samples at Day 0 and Day 30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the intestinal microbiota by PCR
for the microbiota, this corresponds to the analysis of bacterial taxa by PCR carried out on faecal samples collected on D0 and D30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of the intestinal microbiota by metagenomics
for the microbiota, this corresponds to the analysis of bacterial taxa by metagenomics carried out on faecal samples collected on D0 and D30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of low-grade chronic inflammatory markers
for low-grade chronic inflammatory markers, this corresponds to the dosage of chemokines, Prostaglandins, interleukins, pro- and anti-inflammatory cytokines, ultra-sensitive CRP by blood samples at D0 and D30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of endotoxemia
for the measurement of endotoxemia, this corresponds to the analysis of circulating LPS, TRL2 and 4 by blood samples on D0 and D30
Measured: measured at Day 0 and Day +30 of the treatment
the evolution of oxidative stress
for the measurement of oxidative stress, this corresponds to the ROS and NADPH oxidase content by blood serum samples at D0 and D30;
Measured: measured at Day 0 and Day +30 of the treatment
the relief experience
It corresponds to the relief of the subjects evaluated on the Patient Global Impression of Improvement scale (PGII scale)
Measured: measured at Day +30 of the treatment
subject satisfaction
It corresponds to the tolerance of the product over the entire study period and in particular the occurrence of diarrhea and to the description of satisfaction on a Likert scale.
Measured: measured at Day +30 of the treatment
the evolution of the incidence of treatment
for the evolution of the incidence of treatment, this corresponds to the lipid profile, NFS, glycaemia, kalemia, transaminases by blood samples on D0 and D30.
Measured: measured at Day 0 and Day +30 of the treatment
subject compliance for taking the product
Unused products are collected to assess compliance by measuring the number of unused product
Measured: measured at Day +30 of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start10 Feb 2017
- Primary completion14 Mar 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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
- Randomized double-blind clinical study versus placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ortis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Biotech
- Responsible party
- Sponsor
- Investigators
- Francois-andré Allaert, Principal investigator, CEN Nutriment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541991
- Sponsor's protocol ID
- C1486
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Rhubarb Extract Supplementation on Stool Frequency and Biological Markers of Intestinal Function in Seniors With a Low Number of Defecations Per Week
- ClinicalTrials.gov ID
- NCT05541991
- Acronym / sponsor ID
- C1486
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ortisIndustry (pharma, biotech, devices)
- Collaborators
- CEN Biotech
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 15 Sep 2022 (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.
Randomized double-blind clinical study versus placebo evaluating the effect of supplementation with rhubarb extract on stool frequency and biological markers of intestinal function in seniors with a low number of defecations per week
Detailed description
The main objective was to evaluate the effect of rhubarb extract supplementation on improving intestinal transit in subjects with a low number of defecations per week.
The secondary objectives are to assess: changes in the appearance of the stool; the evolution of the quality of life; the evolution of biological markers of intestinal function; the evolution of the intestinal microbiota; the evolution of low-grade chronic inflammatory markers; the evolution of endotoxemia; the evolution of oxidative stress; the relief experienced; subject satisfaction; the evolution of safety dosages; subject compliance.
The main efficacy criterion is the improvement in intestinal transit assessed by the frequency of stool emissions reported daily from D-14 to D 30.
The secondary endpoints correspond to the evolution of the aspect of the stools evaluated by the Bristol Stool Scale and the evolution of the quality of life evaluated by the SF-12.
They also correspond to the relief of the subjects evaluated on the PGII scale, to the tolerance of the product over the entire study period and in particular the occurrence of diarrhea and to the description of satisfaction on a Likert scale.
Regarding the biological assays, they correspond to:
- for biological markers of intestinal function to those specific to intestinal transit, i.e. active GLP-1, total GIP total PYY, PP (DPPIV substrates), Leptin, Insulin, by blood samples at D0 and D30 and that specific for permeability intestinal or claudin-3 by urine samples at D0 and D30;
- for the microbiota, analysis of bacterial taxa by PCR and metagenomics carried out on faecal samples collected on D0 and D30;
- for chronic low-grade chemokine inflammatory markers, Prostaglandins, interleukins, pro- and anti-inflammatory cytokines, ultra-sensitive CRP by blood samples at D0 and D30;
- for the measurement of endotoxaemia in the analysis of circulating LPS, TRL2 and 4 by blood samples on D0 and D30;
- for the measurement of oxidative stress to the ROS and NADPH oxidase content by blood serum samples at D0 and D30;
- for the safety assays for the lipid profile, NFS, glycaemia, kalemia, transaminases by blood samples on D0 and D30.
The studied product is a food supplement composed of a rhubarb extract standardized, characterized and optimized in order to improve these functional effects on the intestinal system (regulation of the local inflammatory system, microflora, peristalsis, etc.) at 2 different doses. The food supplement comes in the form of a film-coated tablet. The comparator product was a placebo with an appearance strictly identical to the verum and contains only excipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized double-blind clinical study versus placebo
| Arm | Type | Receives |
|---|---|---|
| Single dose product | Experimental | Dietary Supplement: single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extractA single dose coated tablet with standardised rhubarb extract is administrated daily in the evening during 30days |
| Double dose product | Experimental | Dietary Supplement: double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extractA double dose coated tablet with standardised rhubarb extract is administrated daily in the evening during 30days |
| placebo product | Placebo comparator | Dietary Supplement: placebo coated tabletA placebo coated tablet without active is administrated daily in the evening during 30days |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presenting a number of stools ≥1 and ≤3 per week during the last month preceding the screening visit and during the last 15 days preceding the inclusion visit;
- stools often (at least 25% of defecations according to the Rome III questionnaire) hard or lumpy, according to the bristol scale, at least the last 3 months over a period of 6 months;
- not currently justifying, according to his attending physician, drug treatment;
- Giving free and informed consent to the study in writing.
Key exclusion criteria (29 listed)
- subject with signs requiring further investigations: odynophagia, involuntary weight loss >10% during the last 3 months before inclusion, persistent vomiting, hematemesis, blood in the stools, iron deficiency anemia, symptoms of obstruction, rectal bleeding, rectal prolapse …;
- subject who has not been screened for colon cancer in the past two years;
- subject participating in another therapeutic trial;
- subject with a serious general pathology and in particular renal or hepatic insufficiency, cancer, chronic pancreatitis;
- premenopausal women;
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 |
|---|---|---|
| single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extractcoated tablet with a single dose of standardised rhubarb extract | Dietary supplement | Single dose product |
| placebo coated tabletcoated tablet without active principle | Dietary supplement | placebo product |
| double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extractcoated tablet with a double dose of standardised rhubarb extract | Dietary supplement | Double dose product |
Primary outcome
change of the number of defecations per week
Time frame: Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)
The main objective was to evaluate the effect of rhubarb extract supplementation on changing intestinal transit in subjects with a low number of defecations per week.
18 secondary outcomes
changes in the appearance of the stool
Time frame: Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)
the change of the quality of life
Time frame: measured at Day -14 and Day +30 of the treatment
the evolution of biological markers of intestinal function
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, active GLP-1
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, total GIP
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, total PYY
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, PP (DPPIV substrates)
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, Leptin
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the biological marker of intestinal function, Insulin
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the intestinal microbiota by PCR
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of the intestinal microbiota by metagenomics
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of low-grade chronic inflammatory markers
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of endotoxemia
Time frame: measured at Day 0 and Day +30 of the treatment
the evolution of oxidative stress
Time frame: measured at Day 0 and Day +30 of the treatment
the relief experience
Time frame: measured at Day +30 of the treatment
subject satisfaction
Time frame: measured at Day +30 of the treatment
the evolution of the incidence of treatment
Time frame: measured at Day 0 and Day +30 of the treatment
subject compliance for taking the product
Time frame: measured at Day +30 of the treatment
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 15 Sep 2022.
- 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.
Francois-andré Allaert principal investigator
CEN Nutriment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract and double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract in people with Constipation - Functional, run by ortis at 1 site in France.
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 29 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 15 Sep 2022. 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 France. 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?
change of the number of defecations per week (time frame: Daily from Day -14 until the selection visit (Day 0) and every day during the 30days of treatment (until Day +30)). 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 15 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.