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

NCT05104424 | Unknown Phase 1 FDA Drug

• 1 other identifier: smell and taste disorders
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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)

  4 month

• 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.

  4 month

• 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

  4 month

Secondary Outcomes (1)

• any clinical manifestations or adverse effects

  4 month

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Drug: Insulin aspart

patients taking zinc only with smell training on volatile oils

PLACEBO COMPARATOR

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

Drug: Insulin aspart

Interventions

Insulin aspart DRUG

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

Also known as: zinc, gabepentin

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

MeSH Terms

Conditions

Olfaction Disorders; Taste Disorders

Interventions

Insulin Aspart; Zinc

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Amr Ahmed

CONTACT

+966597310032; drmedahmed@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical researcher and Director of mobile team tuberculosis program

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 3, 2021
• Study Start: December 26, 2021
• Primary Completion: August 26, 2022
• Study Completion: October 1, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share