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IRCT20110603006699N6 IRCT 2024-04-30 Esfahan University of Medical Sciences Efficacy and safety of Acupuncture in the treatment of post COVID-19 Olfactory Dysfunction COVID-19 Investigating the Effect of Acupuncture on improving the quality of smell in patients with persistent Olfactory Dysfunction after infection with the COVID-19 Virus 2023-05-10 anticipated 60 Complete https://irct.ir/trial/74944 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the Random Allocation method will be used. Before beginning the sampling process, we will establish the Randomization sequence and then proceed with Sampling. In this scenario, we will have two vases. The first vase will contain cards numbered from 1 to 60. In vase number 2, there will be 60 non-transparent envelopes containing the desired type of treatment. First, we will randomly select a card from the first vase and an envelope from the second vase and place them in a designated box. In this way, the number removed from pot #1 will receive the treatment that is removed from pot #2. This process will be repeated for all 60 numbers. That is, we will have 60 numbers in the designated box, and each number will correspond to an envelope containing treatment. It should be noted that the type of treatment will be concealed within the envelope until the patients are assigned, and no individual will be aware of the treatment (real acupuncture or placebo acupuncture) given to the patients until their appointment. In fact, the type of intervention inside each envelope is unclear. It is uncertain whether this method involves randomization concealment. In fact, the treatment assigned to the numbers will not be known until the person visits and the envelope is opened for them, Blinding description: In a single-blind study, participants are randomly assigned to two groups. In the first group (test group), real acupuncture is used. Sham acupuncture is used in the second group. N/A Olfactory Disorder. Intervention 1: Intervention group: After random allocation, an Olfactory test will be conducted in two sessions: the first session (before the intervention) and the second session (four weeks after the end of the intervention). In the intervention group, Real Acupuncture is utilized. Intervention 2: Control group: After random allocation, an Olfactory test will be conducted in two sessions: the first session (before the intervention) and the second session (four weeks after the end of the intervention). Sham Acupuncture is used in the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mohammad Javad Firouz Vishkasougheh
Ayatollah Kashani Hospital, Isfahan.
Isfahan Iran (Islamic Republic of) 8183983434 +98 31 3233 0091 mohammadj.firouzi@gmail.com Esfahan University of Medical Sciences scientific Mehrdad Rogha
Hezar jarib street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3664 0352 rogh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with a confirmed diagnosis of COVID-19 in the past who have self-reported Olfactory Disorders. Within a month of contracting the disease, they show no signs of recovery from their Olfactory Disorder. no limit no limit Both People with a history of any Irritation or Trauma to the Head, Severe Chronic Inflammatory Diseases, Degenerative Diseases (causing Destruction or Disintegration of Nasal Mucosa), and Nasal Allergies. People with Abnormal Nasal Anatomy G52 Disorders of olfactory nerve Treatment - Devices Placebo Intervention group: After random allocation, an Olfactory test will be conducted in two sessions: the first session (before the intervention) and the second session (four weeks after the end of the intervention). In the intervention group, Real Acupuncture is utilized. Control group: After random allocation, an Olfactory test will be conducted in two sessions: the first session (before the intervention) and the second session (four weeks after the end of the intervention). Sham Acupuncture is used in the control group. Percentage of people with an improved sense of Olfaction. Timepoint: Conduct an olfactory test before starting the intervention and four weeks after the intervention ends. Method of measurement: Using a short Self-assessment of Olfactory Questionnaire (Self-MOQ). Esfahan University of Medical Sciences Approved 2023-05-07 Ethical Committee of Isfahan University of Medical Sciences Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)