Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis

Status unconfirmed · Phase 4

Conditions studied: Allergic Rhinitis

In brief

The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.

Key facts

Study ID

NCT00825656

Run by

Strategic Biosciences

People needed

20

Starts

2008-09-01

Expected to finish

2009-01-01

Last updated by the study team

2009-01-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing to participate as indicated by providing written informed consent
• 12 years of age or older, of any gender and any race
• Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years
• A history of allergic rhinitis, for at least 2 years
• Have undergone washout of all medications that could have an influence on the study
• Willing and able to make required study visits
• Able to follow instructions and record diary symptoms.
• Free of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination
• Have a TNSS between 4 and 12 averaged over the 7 days immediately prior to V2
• Have an average individual score for nasal congestion greater than or equal to 2 over the 7 days immediately prior to V2.

You may not qualify if…

• any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps
• any other anatomic nasal deformity that could interfere with their participation in the study
• asthma, with the exception of mild intermittent asthma
• congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril)
• use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days
• be undergoing allergy immunotherapy, unless on a stable dosing regimen throughout the course of the study
• Be using dermal potent or super-potent topical corticosteroids
• any systemic disorder that could interfere with the evaluation of the study medication
• hypersensitivity to the study drugs or any component thereof
• history of drug or alcohol abuse that would interfere with participation in the study
• history of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses that could be expected to interfere with the study
• upper or lower respiratory infection within 14 days of Vist 2
• acute sinusitis within 30 days of Visit 2
• any history or evidence of nasolacrimal drainage system malfunction
• Be planning to travel to an area significantly antigenically different for a substantial portion (more than 48 hours) of any given study week.
• participation in any other investigational study within 30 days before entry into this study or concomitantly with this study
• chronic or intermittent use of any prescription or over-the-counter (OTC) nasal spray during the study period

Where it is running

• Institute for Allergy and Asthma — Wheaton, Maryland, United States

Full record on ClinicalTrials.gov

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