Smell DysfunctionPhase 1COVID-19NCT05104424
The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions
A Phase 1 study testing Insulin aspart in people with Smell Dysfunction and Taste Disorders, run by Ministry of Health, Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smell Dysfunction, Taste Disorders, Taste Disorder, Secondary, Sweet
- What is being tested?
- Insulin aspart
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2021to 1 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult male or female recovered patients only postcovid-19 no other interventional treatment
Who cannot join
- less than 18 years any nasal deviation or congenital anomalies any allergic sinusitis or nasal problems pregnant women's
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post Covid-19 Smell and Taste Dysfunctions
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
Read the 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
- Being tested
- Insulin aspart
- Medical subject headings
- Olfaction Disorders, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin aspartDrug
Also called zinc, gabepentin
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 4 month
Secondary outcomes (1)
any clinical manifestations or adverse effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start26 Dec 2021 (estimated)
- Primary completion26 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smell DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104424
- Sponsor's protocol ID
- smell and taste disorders
- Acronym
- COVID-19
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post Covid-19 Smell and Taste Dysfunctions
- ClinicalTrials.gov ID
- NCT05104424
- Acronym / sponsor ID
- COVID-19 / smell and taste disorders
- Conditions
- Smell Dysfunction, Taste Disorders, Taste Disorder, Secondary, Sweet, Taste Disorder, Secondary, Bitter, Smell Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 26 Dec 2021 (estimated)
- Primary completion
- 26 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adult post covid-19 recovered 22 patients with smell and taste dysfunction take quadruple therapy | Active comparator | Drug: Insulin aspartadult 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. |
| patients taking zinc only with smell training on volatile oils | Placebo comparator | Drug: Insulin aspartthese 22 adult patients on zinc 50 mg and smell training on 4 volatile oils |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult male or female recovered patients only postcovid-19 no other interventional treatment
Key exclusion criteria (2 listed)
- less than 18 years any nasal deviation or congenital anomalies any allergic sinusitis or nasal problems pregnant women's
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin aspartAlso: zinc, gabepentinintranasal 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 | Drug | 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 |
Primary outcome
evaluation of disturbances of smell and taste (Sniffin 'Sticks" test)
Time frame: 4 month
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
Time frame: 4 month
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)
Time frame: 4 month
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
1 secondary outcome
any clinical manifestations or adverse effects
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin aspart in people with Smell Dysfunction and Taste Disorders, run by Ministry of Health, Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Ahmed (+966597310032, drmedahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of disturbances of smell and taste (Sniffin 'Sticks" test) (time frame: 4 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.