Seasonal Allergic RhinitisPhase 4NCT00460538
Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms
A Phase 4 study testing Lectranal in people with Seasonal Allergic Rhinitis, run by Milsing d.o.o. at 1 site in Croatia.
Trial summary
The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Lectranal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCroatia
- Study dates
- Apr 2007to Nov 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of seasonal allergic rhinitis symptoms to pollen
- positive skin prick test to pollen
- negative history of seasonal allergic asthma
- male or female older than 18
- female participants must use appropriate contraception
- able to comply to study procedures
Who cannot join
- pregnancy
- alcohol or drug abuse
- subject receiving antihistamines , immunotherapy or on hyposensibilisation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.
Read the detailed description
Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Lectranal, placebo
- Keywords
- Seasonal allergic rhinitis, lectranal, allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LectranalDietary supplement
Dosage form: capsule
1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks
placeboDietary supplement
Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
| 1 | Active comparator | Not described Receives: Dietary Supplement: Lectranal |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in SARS (seasonal allergic rhinitis symptoms)
Measured: 6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)
Measured: 6 weeks
changes in specific IgE
Measured: 6 weeks
changes in specific IgG
Measured: 6 weeks
Secondary outcomes (2)
Prick test change
Measured: 6 weeks
change in eosinophilia in nasal secretion
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionNov 2007
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 Seasonal Allergic RhinitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milsing d.o.o.
- Sponsor type
- University, hospital or other
- Investigators
- Neven Tudoric, MD PhD, Principal investigator, Dubrava University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460538
- Sponsor's protocol ID
- MIL-002
- Status last verified
- Mar 2010
- First submitted
- 13 Apr 2007
- Last updated
- 5 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matkovic Z, Zivkovic V, Korica M, Plavec D, Pecanic S, Tudoric N. Efficacy and safety of Astragalus membranaceus in the treatment of patients with seasonal allergic rhinitis. Phytother Res. 2010 Feb;24(2):175-81. doi: 10.1002/ptr.2877.
PubMed 19504468
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms
- ClinicalTrials.gov ID
- NCT00460538
- Acronym / sponsor ID
- MIL-002
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal allergic rhinitis, lectranal, allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Milsing d.o.o.University, hospital or other
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 Apr 2007 (estimated)
- 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 the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.
Detailed description
Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Dietary Supplement: placebo |
| 1 | Active comparator | Dietary Supplement: Lectranal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- history of seasonal allergic rhinitis symptoms to pollen
- positive skin prick test to pollen
- negative history of seasonal allergic asthma
- male or female older than 18
- female participants must use appropriate contraception
Key exclusion criteria (3 listed)
- pregnancy
- alcohol or drug abuse
- subject receiving antihistamines , immunotherapy or on hyposensibilisation
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 |
|---|---|---|
| LectranalDosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks | Dietary supplement | 1 |
| placeboDosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks | Dietary supplement | 2 |
Primary outcome
changes in SARS (seasonal allergic rhinitis symptoms)
Time frame: 6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)
Time frame: 6 weeks
changes in specific IgE
Time frame: 6 weeks
changes in specific IgG
Time frame: 6 weeks
2 secondary outcomes
Prick test change
Time frame: 6 weeks
change in eosinophilia in nasal secretion
Time frame: 6 weeks
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 5 Apr 2010.
- Results publication: PubMed 19504468Matkovic Z, Zivkovic V, Korica M, Plavec D, Pecanic S, Tudoric N. Efficacy and safety of Astragalus membranaceus in the treatment of patients with seasonal allergic rhinitis. Phytother Res. 2010 Feb;24(2):175-81. doi: 10.1002/ptr.2877.
Related trials for Seasonal Allergic Rhinitis
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Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
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Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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.
Neven Tudoric, MD PhD principal investigator
Dubrava University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lectranal in people with Seasonal Allergic Rhinitis, run by Milsing d.o.o. at 1 site in Croatia.
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 3 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 5 Apr 2010. 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 Croatia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in SARS (seasonal allergic rhinitis symptoms) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460538, 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 5 Apr 2010.