ALAP-1 for the attenuation of nasal provocation with histamine in seasonal allergic rhinitis: a randomised, double-blind, placebo-controlled, three-day dosing, cross-over study and dose finding one month cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83077547

Enrollment

Registered

2008-01-25

Start date

2006-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal allergic rhinitis Respiratory Seasonal allergic rhinitis

Interventions

ALAP-1 (herbal combination) versus placebo. ALAP-1 is an herbal combination formulated to prevent and reduce AR symptoms. This proprietary formula is a standardised blend of the following eleven botan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 - 59 years, either sex 2. A history of seasonal allergic rhinitis

Exclusion criteria

Exclusion criteria: 1. Atrophic rhinitis 2. Rhinitis medicamentosa 3. Nasal polyps 4. Septal deviation 5. Active bacterial or viral sinusitis 6. Severe asthma 7. Peptic ulcer disease or active gastroesophageal reflux disease (GERD) 8. History of anaphylaxis to any allergen 9. Pregnancy 10. Active bacterial or viral rhinitis 11. Nasal surgery within the last eight weeks

Design outcomes

Primary

Measure	Time frame
Peak nasal inspiratory flow meter, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days.	—

Secondary

Measure	Time frame
Sneeze score, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days.	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026