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Status unknownNCT00825656SMANUpdated Jan 23, 2009

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

A Phase 4 interventional study of Sinol or Sinol-M nasal spray in Allergic Rhinitis, sponsored by Strategic Biosciences. Status unknown at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-01-23.

Sponsored by Strategic Biosciences · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Sinol is an FDA registered, capsaicin-based, over-the-counter homeopathic nasal spray used for the relief of allergy and sinus conditions. It is an all-natural product that the patient uses on an as-needed basis for up to 12 times daily.

Sinol has been available in the US since 2004. In 2009 a second generation product, Sinol-M will be launched. Sinol-M is identical to the original formula but also contains MucoAd MucoAd™ is a patented non-toxic, non-irritating, liquid polymer mucoadhesive carrier that prolongs the contact time between drug and mucosa, thus increasing bioavailability. It can be loaded with nearly any pharmaceutical preparation and delivered a variety of mucosal tissues. Reduced mucociliary clearance of intranasally-applied drugs is desirable to reduce the naturally-occurring washing out of topically applied medications.

The objective of the current Phase IV, randomized, double-blind, cross-over study, was to evaluate the frequency of use and efficacy of SINOL and SINOL + MucoAd™ (Sinol-M) and to demonstrate non-inferiority of Sinol-M versus the existing product Sinol.

Additionally, as most homeopathic drugs are not supported by prospective clinical data there is a belief among many mainstream healthcare practitioners, and some consumers that these products do not work. This study therefore provides an opportunity to demonstrate improved efficacy versus no treatment (during the run-in and washout phases).

02

Conditions studied

  • Allergic Rhinitis

Keywords

  • Allergic Rhinitis
  • Capsaicin
  • Homeopathic
  • Sinol
  • Sinol-M
03

In context

Rhinitis

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

This study's planned enrollment of 20 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

This is the only study on the registry with Strategic Biosciences as lead sponsor.

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

04

Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    1

    Sinol-M

    Drug: Sinol or Sinol-M nasal spray

  • Active comparator
    2

    Sinol

    Drug: Sinol or Sinol-M nasal spray

Interventions

  • DrugSinol or Sinol-M nasal spray

    One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis

    Also known as: Capsaicin nasal spray

06

What researchers measure

Primary outcomes

  1. Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)

    Time frame: twice daily for 28 days

Secondary outcomes

  1. Number of sprays of study drug used

    Time frame: twice daily for 28 days

07

Study locations

1 site
  • Institute for Allergy and Asthma
    Wheaton, Maryland 20902, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00825656
Lead sponsor
Strategic Biosciences
First posted
Jan 21, 2009
Start date
Sep 2008
Primary completion
Jan 2009 (estimated)
Completion
Jan 2009 (estimated)
Last update
Jan 23, 2009

Study contacts

Martha White, MD
principal investigator · Institute for Allergy and Asthma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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