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

NCT ID: NCT05104424

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-26
• Study Completion Date: 2022-10-01

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Insulin aspart

Intervention Type: 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

patients taking zinc only with smell training on volatile oils

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

Group Type: PLACEBO_COMPARATOR

Insulin aspart

Intervention Type: 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

Interventions

Insulin aspart

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

Intervention Type: DRUG

Other Intervention Names

zinc; gabepentin

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Saudi Arabia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Amr kamel khalil Ahmed

clinical researcher and Director of mobile team tuberculosis program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Amr Ahmed

Role: CONTACT

Phone: +966597310032

Email: drmedahmed@gmail.com

Other Identifiers

smell and taste disorders

Identifier Type: -

Identifier Source: org_study_id