Efficacy and Safety of Lectranal® in Treatment of Seasona... | NCT00460538

Studies
Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

NCT00460538

Sponsor

Milsing d.o.o.

Status

Completed

Last Update Posted

Apr 5, 2010Estimated

Enrollment

48Actual

Phase

Phase 4

Conditions

Seasonal Allergic Rhinitis

Interventions

Lectranal
placebo

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Apr 13, 2007

First Submission Date that Met QC Criteria

Apr 13, 2007

First Posted Date

Apr 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2010

Last Update Posted Date

Apr 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Placebo Comparator		Dietary Supplement: placebo
1	Active Comparator		Dietary Supplement: Lectranal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lectranal	Dietary Supplement	Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in SARS (seasonal allergic rhinitis symptoms)		6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)		6 weeks
changes in specific IgE		6 weeks
changes in specific IgG		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Prick test change		6 weeks
change in eosinophilia in nasal secretion		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy
alcohol or drug abuse
subject receiving antihistamines , immunotherapy or on hyposensibilisation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neven Tudoric, MD PhD	Dubrava University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dubrava University Hospital		Zagreb		10000	Croatia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19504468	Result	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.

ID	Term
D006255	Rhinitis, Allergic, Seasonal
D006967	Hypersensitivity

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases