Allergic RhinoconjunctivitisNCT03365648
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
A study testing Lertal® + standard therapy in people with Allergic Rhinoconjunctivitis, run by NTC srl at 17 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Lertal® + standard therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 17 sitesItaly
- Study dates
- 15 Sep 2017to 13 Nov 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 12 years
- Male or female
- Diagnosis of allergic rhinoconjunctivitis
- Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months
- Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion
- Written informed consent of patient and of parent or legal guardian
Who cannot join
- Uncontrolled asthma
- Secondary rhinitis to other causes
- Documented evidence of acute or chronic sinusitis
- Nasal polyps
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids
- Use of leukotriene antagonists
Show all 18Show fewer
- Continuous use of antihistamines
- Inadequate washout of drugs:
- Systemic or intranasal corticosteroids: 1 month
- Leukotriene antagonists: 1 month
- Sodium cromoglycate: 2 weeks
- Systemic or intranasal decongestants: 3 days
- Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days
- Malformations of the nose, ear or throat
- Upper or lower respiratory tract infection in the last 2 weeks
- Participation in other clinical studies in the last month
- Documented hypersensitivity to the study product or its excipients
- Trip planned outside of the study area
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites
A.O.U. Consorziale "Policlinico Giovanni XXIII"
Bari, BA, 70126
A.O.U. Consorziale "Policlinico-Giovanni XXIII"
Bari, BA, 70126
P.O. di Busto Arsizio - ASST Valle Olona
Busto Arsizio, VA, 21051
A.O.U. Policlinico Vittorio Emanuele
Catania, CT, 95123
P.O. San Giovanni di Dio - ASP di Crotone
Crotone, KR, 88900
P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense
Garbagnate Milanese, MI, 20042
Istituto Giannina Gaslini
Genova, GE, 16132
Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila
L’Aquila, AQ, 67100
Ospedale Civile di Legnano - ASST Ovest Milanese
Legnano, MI, 20162
A.O.U. Policlinico "G. Martino"
Messina, ME, 98124
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Milan, MI, 20157
Az. Osp. Univ. dell'Università degli Studi della Campania "Luigi Vanvitelli"
Naples, 80138
Fondazione IRCCS Policlinico San Matteo
Pavia, (PV), 27100
Ospedale di Polistena "Santa Maria degli Ungheresi" - ASP di Reggio Calabria
Polistena, RC, 89024
A.O.U. Policlinico Umberto I
Roma, RM, 00161
Ospedale Città di Sesto San Giovanni - ASST Nord Milano
Sesto San Giovanni, MI, 20099
About this study
Official title: A Randomized, Double-blinded, Parallel-group, Placebo-controlled Clinical Study of the Efficacy and Safety of an Oral Nutraceutical (Lertal®) as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.
Read the detailed description
Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in developed countries. It is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. AR can also have detrimental effects on mood, sleep, social activities and scholastic performance.
Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults.
The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Lertal® + standard therapy, Placebo + standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lertal® + standard therapyDietary supplement
Lertal® is a novel food supplement. Each tablet contains the following active ingredients:
- Quercetin 150 mg: a natural flavonoid that inhibits the release of histamine, leukotrienes, PGD2, IL (IL-6, IL-8, TNF-alpha).
- Perilla frutescens 80 mg: A dry extract of the seeds containing rosmarinic acid, luteolin, apigenin and crysoeriol that inhibits the release of histamine and expression of interleukins (IL-6, TNF-alpha).
- Vitamin D3 5 mcg (200 IU), which contributes to the normal function of the immune system.
Standard therapy: antihistamine.
Placebo + standard therapyOther
Placebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine.
Standard therapy: antihistamine
| Study group | Role | What they receive |
|---|---|---|
| Lertal® + standard therapy | Experimental | Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) Receives: Dietary Supplement: Lertal® + standard therapy |
| Placebo + standard therapy | Placebo comparator | Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) Receives: Other: Placebo + standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Symptom Score (TSS) scores
Changes from baseline of Total Symptom Score (TSS) scores will be calculated after 4 weeks of treatment. The Total Symptoms score is a patient-reported evaluation of nine symptoms:
- Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion
- Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing
- Throat symptoms (Total Throat Symptom Score): itching, coughing
With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms.
The between-group analysis will be performed by means of a t-test for independent samples or analogous non-parametric test.
Measured: At Baseline and after Visit 4 (Week 4)
Secondary outcomes (12)
Visual Analogue Scale (VAS) score
The patient will be asked to indicate overall system distress on a 100 mm Visual Analogue Scale (VAS) were 0 is equal to no discomfort and 100 the worst possible discomfort. Change from baseline of Visual Analogue Scale (VAS) score after 2 and 4 weeks of treatment. The between-group analysis will be performed using a t-test for independent samples or analogous nonparametric test.
Measured: At Baseline, after Visit 3 (Week 2) and after Visit 4 (Week 4)
Total Symptom Score (TSS) scores
Change from baseline of Total Symptom Score (TSS) scores after 2 weeks of treatment. The Total Symptoms score is a patient-reported evaluation of nine symptoms:
- Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion
- Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing
- Throat symptoms (Total Throat Symptom Score): itching, coughing
With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms.
The between-group analysis will be performed by means of a t-test for independent samples or analogous non-parametric test.
Measured: At Baseline and after Visit 3 (Week 2)
Number of responders (30% reduction of TSS)
Change from baseline of TSS score for each patient after 2 and 4 weeks of treatment will be classified as ≥ 30% and < 30%, thus defining responder and non-responder patients. Between-group differences will be tested by means of a Chi-square test with 2x2 contingency tables.
Measured: After Visit 3 (Week 2) and after Visit 4 (Week 4)
Time to maximum effect on Total Symptom Score (TSS) vs placebo
Time to maximum effect on Total Symptom Score (TSS) vs placebo will be analysed by means of t-test for independent samples after logtransformation of the data or analogous non-parametric test. The Total Symptoms score is a patient-reported evaluation of nine symptoms:
- Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion
- Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing
- Throat symptoms (Total Throat Symptom Score): itching, coughing
With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms.
Measured: From baseline to Visit 6 (Week 16)
Number of patients using rescue treatment
Between-group differences in the number of patients using rescue treatment will be analyzed by means of a Chi-square test with 2x2 contingency tables.
Measured: From baseline to Visit 6 (Week 16)
Total Nasal Symptom Score (TNSS)
The Total Nasal Symptom Score is a patient-reported evaluation of the following symptoms: itching, sneezing, rhinorrhea, nasal congestion. With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
Changes from baseline in Total Nasal Symptom Score (TNSS) scores will be calculated after 2 and 4 weeks of treatment and between-group differences analyzed using a t-test for independent samples or analogous non-parametric test.
Measured: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
Total Ocular Symptom Score (TOSS)
The Total Ocular Symptom Score is a patient-reported evaluation of the following symptoms: itching, hyperemia of conjunctiva, tearing. With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
Changes from baseline in Total Ocular Symptom Score (TOSS) scores will be calculated after 2 and 4 weeks of treatment and between-group differences analyzed using a t-test for independent samples or analogous non-parametric test.
Measured: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
Total Throat Symptom Score (TTSS)
The Total Throat Symptom Score is a patient-reported evaluation of the following symptoms: itching, coughing. With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks.
Changes from baseline in Total Throat Symptom Score (TTSS) scores will be calculated after 2 and 4 weeks of treatment and between-group differences analyzed using a t-test for independent samples or analogous non-parametric test.
Measured: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
Number of patients symptom-free or with mild symptoms
The number of patients with score for a single symptom ≤ 1 will be calculated and the between-group differences analyzed by means of a Chi-square test with 2xn contingency tables, where n represents the number of observations.
Measured: From V3 (Week 2) to Visit 4 (Week 4)
Number of exacerbations
Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration.
Measured: From Visit 5 (Week 8) to Visit 6 (Week 16)
Intensity (mild, moderate, severe) of exacerbations
Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration.
Measured: From Visit 5 (Week 8) to Visit 6 (Week 16)
Duration (number of days) of exacerbations
Exacerbations are defined as the need of an antihistamine medication of any kind, at any dose and of any duration.
Measured: From Visit 5 (Week 8) to Visit 6 (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 Sep 2017
- Primary completion4 Jul 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinoconjunctivitisStudies 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, parallel-group, placebo-controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- NTC srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gian Luigi Marseglia, Prof., Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365648
- Sponsor's protocol ID
- LER 02-2017
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marseglia G, Licari A, Leonardi S, Papale M, Zicari AM, Schiavi L, Ciprandi G; Italian Study Group on Pediatric Allergic Rhinoconjunctivitis. A polycentric, randomized, parallel-group, study on Lertal(R), a multicomponent nutraceutical, as preventive treatment in children with allergic rhinoconjunctivitis: phase II. Ital J Pediatr. 2019 Jul 18;45(1):84. doi: 10.1186/s13052-019-0678-y.
PubMed 31319883
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Parallel-group, Placebo-controlled Clinical Study of the Efficacy and Safety of an Oral Nutraceutical (Lertal®) as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
- ClinicalTrials.gov ID
- NCT03365648
- Acronym / sponsor ID
- LER 02-2017
- Conditions
- Allergic Rhinoconjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NTC srlIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 7 Dec 2017 (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.
The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.
Detailed description
Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in developed countries. It is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. AR can also have detrimental effects on mood, sleep, social activities and scholastic performance.
Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults.
The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blinded, parallel-group, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Lertal® + standard therapy | Experimental | Dietary Supplement: Lertal® + standard therapyLertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) |
| Placebo + standard therapy | Placebo comparator | Other: Placebo + standard therapyPlacebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6 to 12 years
- Male or female
- Diagnosis of allergic rhinoconjunctivitis
- Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months
- Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion
Key exclusion criteria (18 listed)
- Uncontrolled asthma
- Secondary rhinitis to other causes
- Documented evidence of acute or chronic sinusitis
- Nasal polyps
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids
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 |
|---|---|---|
| Lertal® + standard therapyLertal® is a novel food supplement. Each tablet contains the following active ingredients: * Quercetin 150 mg: a natural flavonoid that inhibits the release of histamine, leukotrienes, PGD2, IL (IL-6, IL-8, TNF-alpha). * Perilla frutescens 80 mg: A dry extract of the seeds containing rosmarinic acid, luteolin, apigenin and crysoeriol that inhibits the release of histamine and expression of interleukins (IL-6, TNF-alpha). * Vitamin D3 5 mcg (200 IU), which contributes to the normal function of the immune system. Standard therapy: antihistamine. | Dietary supplement | Lertal® + standard therapy |
| Placebo + standard therapyPlacebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine. Standard therapy: antihistamine | Other | Placebo + standard therapy |
Primary outcome
Total Symptom Score (TSS) scores
Time frame: At Baseline and after Visit 4 (Week 4)
Changes from baseline of Total Symptom Score (TSS) scores will be calculated after 4 weeks of treatment. The Total Symptoms score is a patient-reported evaluation of nine symptoms: * Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion * Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing * Throat symptoms (Total Throat Symptom Score): itching, coughing With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks. The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms. The between-group analysis will be performed by means of a t-test for independent samples or analogous non-parametric test.
12 secondary outcomes
Visual Analogue Scale (VAS) score
Time frame: At Baseline, after Visit 3 (Week 2) and after Visit 4 (Week 4)
Total Symptom Score (TSS) scores
Time frame: At Baseline and after Visit 3 (Week 2)
Number of responders (30% reduction of TSS)
Time frame: After Visit 3 (Week 2) and after Visit 4 (Week 4)
Time to maximum effect on Total Symptom Score (TSS) vs placebo
Time frame: From baseline to Visit 6 (Week 16)
Number of patients using rescue treatment
Time frame: From baseline to Visit 6 (Week 16)
Total Nasal Symptom Score (TNSS)
Time frame: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
Total Ocular Symptom Score (TOSS)
Time frame: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
Total Throat Symptom Score (TTSS)
Time frame: At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4)
Number of patients symptom-free or with mild symptoms
Time frame: From V3 (Week 2) to Visit 4 (Week 4)
Number of exacerbations
Time frame: From Visit 5 (Week 8) to Visit 6 (Week 16)
Intensity (mild, moderate, severe) of exacerbations
Time frame: From Visit 5 (Week 8) to Visit 6 (Week 16)
Duration (number of days) of exacerbations
Time frame: From Visit 5 (Week 8) to Visit 6 (Week 16)
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 Nov 2018.
- Derived from this study: PubMed 31319883Marseglia G, Licari A, Leonardi S, Papale M, Zicari AM, Schiavi L, Ciprandi G; Italian Study Group on Pediatric Allergic Rhinoconjunctivitis. A polycentric, randomized, parallel-group, study on Lertal(R), a multicomponent nutraceutical, as preventive treatment in children with allergic rhinoconjunctivitis: phase II. Ital J Pediatr. 2019 Jul 18;45(1):84. doi: 10.1186/s13052-019-0678-y.
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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.
Gian Luigi Marseglia, Prof. principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lertal® + standard therapy in people with Allergic Rhinoconjunctivitis, run by NTC srl at 17 sites in Italy.
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 6 inclusion and 18 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. 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?
Total Symptom Score (TSS) scores (time frame: At Baseline and after Visit 4 (Week 4)). 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 NCT03365648, which also lists 1 linked publication.
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 Nov 2018.