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The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions (COVID-19)

Primary Purpose

Smell Dysfunction, Taste Disorders, Taste Disorder, Secondary, Sweet

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin aspart
Sponsored by
Ministry of Health, Saudi Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smell Dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult male or female recovered patients only postcovid-19 no other interventional treatment

Exclusion Criteria:

less than 18 years any nasal deviation or congenital anomalies any allergic sinusitis or nasal problems pregnant women's

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    adult post covid-19 recovered 22 patients with smell and taste dysfunction take quadruple therapy

    patients taking zinc only with smell training on volatile oils

    Arm Description

    adult patients recovered postcovid-19 taking the quadruple therapy zinc 50 mg , gabapentin 300 mg , 40 I.U rapid insulin , 3 times small cube of ice in the mouth Questionnaires will be administered pre- and post-treatment to assess the change in measures. The mean values between groups will be compared.

    these 22 adult patients on zinc 50 mg and smell training on 4 volatile oils

    Outcomes

    Primary Outcome Measures

    evaluation of disturbances of smell and taste (Sniffin 'Sticks" test)
    The change in smell is based on the comparison of the results of the olfactory assessment after / before treatment obtained from a single method out of the three carried out: Sniffin 'Stick Test Results: Threshold Test Score and Actual Identification Test Score. TI score: sum of the individual scores of the threshold and identification measures (TI score varying from 0 to 32). It is used to classify patients in terms of normosmia, hyposmia and functional anosmia based on normative values of "Sniffin 'Sticks" (according to the age and sex of each subject) with the threshold at the tenth percentile of the database provided in the study published by Hummel and Kobal. Self-assessment by patients using a digital scale of smell, from 0 (no smell) to 10 (normal smell)
    evaluation of taste disorders
    A device is used to present a pseudo-randomised series of taste solutions to the participant for identification, in order to establish taste thresholds.Change in taste threshold measures (sweet, salt, bitter, sour) between baseline and and post treatment is initiated is assessed with the assistance of a taste test device.
    questionnaire for taste self assessment ( Dynachron-olfaction questionnaire)
    Self-assessment using the Dynachron-olfaction questionnaire:each question is used to assess the patient's feelings about his discomfort in the nose using a scale from 0 (no discomfort) to 10 (unbearable

    Secondary Outcome Measures

    any clinical manifestations or adverse effects
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"

    Full Information

    First Posted
    October 25, 2021
    Last Updated
    October 30, 2021
    Sponsor
    Ministry of Health, Saudi Arabia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05104424
    Brief Title
    The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions
    Acronym
    COVID-19
    Official Title
    The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post Covid-19 Smell and Taste Dysfunctions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 26, 2021 (Anticipated)
    Primary Completion Date
    August 26, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Health, Saudi Arabia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    post covid-19 smell and taste dysfunction are common globally and affect the quality of life and also have phycological impact and anxiety, also affect on economy as the patients not able to do cooking or buy prepared foods and not eaten, also not able to enter the cooking room and prepare foods for themselves, also the risk of loss of smell the fire accidents because anosmia, many forms of smell dysfunction like anosmia ,hyposmia, and dysosmia ,Phantosmia , parosmia may occurred, the same taste disorders may has many forms like Dysgeusia, phantom taste perception, hypogeusia with dysgeusia. until now no definite treatments for post covid-19 smell and taste disorders , this study is novel study as quadruple therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation may suspect having promising results
    Detailed Description
    post covid-19 smell and taste dysfunction are common globally and affect the quality of life and also have phycological impact and anxiety, also effect on economy as the patients not able to do cooking or buy prepared foods and not eaten, also not able to enter the cooking room and prepare foods for themselves, also the risk of loss of smell the fire accidents because anosmia, many forms of smell dysfunction like anosmia , hyposmia, and dysosmia , Phantosmia , parosmia may occurred, the same taste disorders may has many forms like Dysgeusia, phantom taste perception, hypogeusia . until now no definite treatments for post covid-19 smell and taste disorders , this study is novel study as quadruple therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation may suspect having promising results. The application of intranasal insulin in healthy humans has been linked to improve memory function and increased olfactory thresholds also enhance the olfactory performance and regenerate the olfactory epithelium which the corner stone mechanism at affection of smell and taste disorders. zinc orally has many functions and improve taste and influence the activity of carbonic anhydrase in saliva which is important in breaking down foods in our mouth . the application of small ice cube in the mouth for one minute may improve seat taste and lower temperature by 5 degrees. gabapentin working by altering or blocking abnormal electrical discharges arising from the peripheral damaged smell or taste organ

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smell Dysfunction, Taste Disorders, Taste Disorder, Secondary, Sweet, Taste Disorder, Secondary, Bitter, Smell Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    adult post covid-19 recovered 22 patients with smell and taste dysfunction take quadruple therapy
    Arm Type
    Active Comparator
    Arm Description
    adult patients recovered postcovid-19 taking the quadruple therapy zinc 50 mg , gabapentin 300 mg , 40 I.U rapid insulin , 3 times small cube of ice in the mouth Questionnaires will be administered pre- and post-treatment to assess the change in measures. The mean values between groups will be compared.
    Arm Title
    patients taking zinc only with smell training on volatile oils
    Arm Type
    Placebo Comparator
    Arm Description
    these 22 adult patients on zinc 50 mg and smell training on 4 volatile oils
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin aspart
    Other Intervention Name(s)
    zinc, gabepentin
    Intervention Description
    intranasal rapid insulin 40 I.U as 0.1 ml as 2 puff at each nostril once weekly for 8 weeks zinc 50 mg orally daily Gabapentin 300 mg once daily for 1 month small ice cube at mouth before meals thrice daily
    Primary Outcome Measure Information:
    Title
    evaluation of disturbances of smell and taste (Sniffin 'Sticks" test)
    Description
    The change in smell is based on the comparison of the results of the olfactory assessment after / before treatment obtained from a single method out of the three carried out: Sniffin 'Stick Test Results: Threshold Test Score and Actual Identification Test Score. TI score: sum of the individual scores of the threshold and identification measures (TI score varying from 0 to 32). It is used to classify patients in terms of normosmia, hyposmia and functional anosmia based on normative values of "Sniffin 'Sticks" (according to the age and sex of each subject) with the threshold at the tenth percentile of the database provided in the study published by Hummel and Kobal. Self-assessment by patients using a digital scale of smell, from 0 (no smell) to 10 (normal smell)
    Time Frame
    4 month
    Title
    evaluation of taste disorders
    Description
    A device is used to present a pseudo-randomised series of taste solutions to the participant for identification, in order to establish taste thresholds.Change in taste threshold measures (sweet, salt, bitter, sour) between baseline and and post treatment is initiated is assessed with the assistance of a taste test device.
    Time Frame
    4 month
    Title
    questionnaire for taste self assessment ( Dynachron-olfaction questionnaire)
    Description
    Self-assessment using the Dynachron-olfaction questionnaire:each question is used to assess the patient's feelings about his discomfort in the nose using a scale from 0 (no discomfort) to 10 (unbearable
    Time Frame
    4 month
    Secondary Outcome Measure Information:
    Title
    any clinical manifestations or adverse effects
    Description
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
    Time Frame
    4 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adult male or female recovered patients only postcovid-19 no other interventional treatment Exclusion Criteria: less than 18 years any nasal deviation or congenital anomalies any allergic sinusitis or nasal problems pregnant women's -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr Ahmed
    Phone
    +966597310032
    Email
    drmedahmed@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions

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