Capsaicin in Treatment of Rhinogenic Headache
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|ClinicalTrials.gov Identifier: NCT03330639|
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Headache Disorders||Other: Capsaicin Other: Placebo||Not Applicable|
- 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 (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized parallel group|
|Official Title:||The Role of Topical Capsaicin in Treatment of Rhinogenic Headache|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||December 2023|
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.
- headache medication use [ Time Frame: 1 year ]We will track the amount of headache medication used during the study period
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330639
|Contact: Christie Barnes, MDemail@example.com|
|Contact: Karli Davis, MPHfirstname.lastname@example.org|