NCT00460538

Brief Summary

The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 5, 2010

Status Verified

March 1, 2010

Enrollment Period

6 months

First QC Date

April 13, 2007

Last Update Submit

April 2, 2010

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitislectranalallergy

Outcome Measures

Primary Outcomes (4)

  • 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 (2)

  • Prick test change

    6 weeks

  • change in eosinophilia in nasal secretion

    6 weeks

Study Arms (2)

2

PLACEBO COMPARATOR
Dietary Supplement: placebo

1

ACTIVE COMPARATOR
Dietary Supplement: Lectranal

Interventions

LectranalDIETARY_SUPPLEMENT

Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks

1
placeboDIETARY_SUPPLEMENT

Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dubrava University Hospital

Zagreb, 10000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 19504468RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalHypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Neven Tudoric, MD PhD

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 16, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

April 5, 2010

Record last verified: 2010-03

Locations

CR(1)