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CompletedNCT00460538Updated Apr 5, 2010

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

A Phase 4 interventional study of Lectranal and placebo in Seasonal Allergic Rhinitis, sponsored by Milsing d.o.o.. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-05.

Sponsored by Milsing d.o.o. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Seasonal Allergic Rhinitis

Keywords

  • Seasonal allergic rhinitis
  • lectranal
  • allergy
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 48 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Milsing d.o.o. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • pregnancy
  • alcohol or drug abuse
  • subject receiving antihistamines , immunotherapy or on hyposensibilisation
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Placebo comparator
    2

    Dietary Supplement: placebo

  • Active comparator
    1

    Dietary Supplement: Lectranal

Interventions

  • Dietary supplementLectranal

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

  • Dietary supplementplacebo

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

06

What researchers measure

Primary outcomes

  1. changes in SARS (seasonal allergic rhinitis symptoms)

    Time frame: 6 weeks

  2. changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)

    Time frame: 6 weeks

  3. changes in specific IgE

    Time frame: 6 weeks

  4. changes in specific IgG

    Time frame: 6 weeks

Secondary outcomes

  1. Prick test change

    Time frame: 6 weeks

  2. change in eosinophilia in nasal secretion

    Time frame: 6 weeks

07

Study locations

1 site
  • Dubrava University Hospital
    Zagreb, 10000, Croatia
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00460538
Lead sponsor
Milsing d.o.o.
First posted
Apr 16, 2007
Start date
Apr 2007
Primary completion
Oct 2007
Completion
Nov 2007
Last update
Apr 5, 2010

Study contacts

Neven Tudoric, MD PhD
principal investigator · Dubrava University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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