Rhino-SinusitisPhase 1/2NCT00610779
Treatment of Acute Rhino-Sinusitis With Essential Oils of Aromatic Plants
A Phase 1/2 study testing mixture of aromatic essential oils. in people with Rhino-Sinusitis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute Rhino-sinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhino-Sinusitis
- What is being tested?
- mixture of aromatic essential oils.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to May 2008
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute Rhino-sinusitis.
- Active disease less than 96 hours
- Patients agree to sign informed consent according to GCP and Israel national regulations.
Who cannot join
- Acute Sinusitis that need to get an antibiotically treatment .
- Nasal polyposis.
- Under any antibiotically treatment.
- Asthma disease.
- Under coumadine therapy.
- Hyper sensitivity to Aromatic essential oils.
- Any immuno-suppressive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Acute Rhino-Sinusitis With Essential Oils of Some Aromatic Medical Plants.
This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute Rhino-sinusitis.
Study objectives: Primary to demonstrate a relief in the nasal obstruction within 20 minutes after first administration of treatment with the spray.
Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment
Read the detailed description
This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute Rhino-sinusitis.
In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Rhino-sinusitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.
- Conditions
- Rhino-Sinusitis
- Being tested
- mixture of aromatic essential oils., placebo
- Keywords
- Rhino-sinusitis;, Herbal medicine;, Traditional medicine;, Aromatic essential oils;
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixture of aromatic essential oils.Dietary supplement
1% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the nose.
placeboDietary supplement
0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | treatment with spray containing aromatic essential oils of some herbal plants. Receives: Dietary Supplement: mixture of aromatic essential oils. |
| 2 | Placebo comparator | spray containing placebo. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray.
Measured: 20 minutes
Secondary outcomes (1)
To demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhino-SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Yoseph Rakover, M.D., Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610779
- Sponsor's protocol ID
- emc070166ctil
- Other IDs
- Rakover2
- Status last verified
- Jun 2008
- First submitted
- 8 Jan 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes