Capsaicin in Treatment of Rhinogenic Headache

NCT03330639 | Withdrawn

• 1 other identifier: 0511-17-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Headache Disorders

Outcome Measures

Primary Outcomes (1)

• headache medication use

  We will track the amount of headache medication used during the study period

  1 year

Secondary Outcomes (2)

• number of patients with treatment related adverse events

  1 year

• headache frequency and severity

  1 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Capsaicin

Placebo Group

PLACEBO COMPARATOR

This group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control.

Other: Placebo

Interventions

Capsaicin OTHER

Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA.

Experimental Group

Placebo OTHER

This group will receive the saline placebo solution.

Placebo Group

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Related Publications (1)

• Gevorgyan A, Segboer C, Gorissen R, van Drunen CM, Fokkens W. Capsaicin for non-allergic rhinitis. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010591. doi: 10.1002/14651858.CD010591.pub2.

  PMID: 26171907 BACKGROUND

MeSH Terms

Conditions

Headache Disorders

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Christie Barnes, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel group

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: November 6, 2017
• Study Start: June 23, 2020
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share