A Phase 1 interventional study of Insulin aspart in Smell Dysfunction, Taste Disorders and Taste Disorder, Secondary, Sweet, sponsored by Ministry of Health, Saudi Arabia. Status unknown. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Ministry of Health, Saudi Arabia · Phase 1, Interventional, and Treatment
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
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
70 studies on the registry are indexed under Olfaction Disorders; 18 are open to participants now.
This study's planned enrollment of 22 is below the median of 60 across 49 interventional studies indexed under Olfaction Disorders.
Browse Olfaction Disorders studies →Ministry of Health, Saudi Arabia is the lead sponsor of 21 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
less than 18 years any nasal deviation or congenital anomalies any allergic sinusitis or nasal problems pregnant women's
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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
these 22 adult patients on zinc 50 mg and smell training on 4 volatile oils
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
Also known as: zinc, gabepentin
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)
Time frame: 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.
Time frame: 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
Time frame: 4 month
any clinical manifestations or adverse effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Time frame: 4 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2021; primary completion for Aug 2022, 8 months later.
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin Aspart
Ministry of Health, Saudi Arabia