- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330639
Capsaicin in Treatment of Rhinogenic Headache
August 16, 2023 updated by: University of Nebraska
The Role of Topical Capsaicin in Treatment of Rhinogenic Headache
Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis.
We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects.
This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution of the sinonasal cavity.
This study is a randomized, double-blinded, parallel trial.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
- Title: The role of capsaicin in treatment of rhinogenic headache
- Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution.
- Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit.
- Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors.
Exclusion Criteria:
- Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
This group will receive the capsaicin.
The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter.
|
Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA.
|
Placebo Comparator: Placebo Group
This group will receive saline.
The Placebo formulation contained saline and eucalyptol in a concentration that matched the control.
|
This group will receive the saline placebo solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
headache medication use
Time Frame: 1 year
|
We will track the amount of headache medication used during the study period
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients with treatment related adverse events
Time Frame: 1 year
|
patients will be asked to report any adverse reactions or events during the study period.
|
1 year
|
headache frequency and severity
Time Frame: 1 year
|
Patient will be asked to record the number of headaches during the study period, and record the severity from 1-10 on the Visual Analog Scale (VAS)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christie Barnes, MD, University of Nebraska
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2017
Primary Completion (Actual)
June 23, 2020
Study Completion (Actual)
June 23, 2020
Study Registration Dates
First Submitted
July 27, 2017
First Submitted That Met QC Criteria
October 30, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 16, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0511-17-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Undecided if sharing IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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