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

Taste Disorders Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05104424
• Other study ID #: smell and taste disorders
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 26, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2021
• Source: Ministry of Health, Saudi Arabia
• Contact: Amr Ahmed
• Phone: +966597310032
• Email: drmedahmed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: October 1, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Disease
• Neoplasm Metastasis
• Olfaction Disorders
• Smell Disorder
• Smell Dysfunction
• Taste Disorder, Secondary, Sweet
• Taste Disorders

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Saudi Arabia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	any clinical manifestations or adverse effects	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"	4 month