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IRCT20210311050671N1 IRCT 2021-04-13 Iran University of Medical Sciences Evaluation of the effect of laser acupuncture on improving the sense of smell in patients with COVID-19 Effect of Auricular Acupuncture with the laser in post-viral anosmia during the COVID-19 pandemic 2021-04-04 anticipated 90 Complete https://irct.ir/trial/54973 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the present study, the simple randomization method will be used. First, the randomization sequence will be determined before sampling begins, and then we will proceed to sampling. In this way we will have 2 pots. In the first pot there will be cards that will be numbered from 1 to 90, and in pot number 2, there will be 90 non-transparent envelope in which the desired treatment will be inserted. First, we will randomly select a card from the first pot and an envelope from the second pot and place them in a designed box. Thus, the number that will come out of pot number 1 will receive the treatment that will come out of pot number 2. We will do this for every 90 numbers. So, we will have 90 numbers in the box, in front of each number will be an envelope in which the treatment is placed. It should be noted that the type of treatment will be in the envelope until the patients are assigned and no one will know the type of treatment of the patients until the patient is referred. In fact, the type of intervention that exists inside each envelope is unclear, which is the randomization concealment method. In fact, the type of intervention that is inside each envelope is unclear, which is a method of concealing random allocation, in which the treatment assigned to the numbers will not be known until the person returns and the envelope is opened for her, Blinding description: Patients will be randomly divided into two groups using a random number table. In both groups, betamethasone drops will be used. In the first group (experimental group) in addition to betamethasone drops, acupuncture and laser will also be used. In the second group, in addition to drops and acupuncture, the laser will be turned off (placebo group). N/A COVID-19. Intervention 1: Intervention group:Betamethasone drops, acupuncture and laser. The final follow-up of patients is 3 months after the first visit.To determine acupuncture sensitive points,both VAS (Vascular Autonomic Signal) or RAC (reflex auriculo-cardiale) method will be used both signals are the result of the micro-stress and vegetative reaction of the irradiated organism to the laser irradiation at the active points of the acupuncture. Acupuncture is performed in 2 sessions with an interval of one week and each session for 20 minutes with stimulation by Izar laser with diode radiation source, power 400 mW, wavelength 810 and specific frequency.The screening method will be performed with 24-item Iranian olfactory test. The olfactory test will be performed in 3 sessions: the first session (before the intervention), the second session (two weeks after the intervention) and the second session (three months after the intervention). Intervention 2: Control group: For patients, in addition to betamethasone drops and acupuncture, laser off (placebo group) will be used. Yes - There is a plan to make this available What will be shared: Individual data of study participants will be shared after being unidentified. When: Access period starts one year after the results are published. To whom: Researchers working in academic and scientific institutions Conditions: They can compare the information of the improved people with the information of the people in their studies. Where to obtain: Via Email:mohebbi.ar@iums.ac.ir How to obtain: An average of two weeks will take up the request to be processed. Comments:
public Alireza Mohebbi
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 2828 mohebbi.ar@iums.ac.ir Iran University of Medical Sciences scientific Alireza Mohebbi
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 2828 mohebbi.ar@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with a definite diagnosis of Covid-19 who have reported an olfactory disorder (Anosmia) and the disorder has no improvement in their olfactory disorder within one month of the course of the disease. no limit no limit Both People with a history of any surgery or head trauma Chronic and severe inflammatory diseases Degenerative diseases Nasal allergies Abnormal anatomy of the nose U07.1 virus identified Treatment - Other Treatment - Other Intervention group:Betamethasone drops, acupuncture and laser. The final follow-up of patients is 3 months after the first visit.To determine acupuncture sensitive points,both VAS (Vascular Autonomic Signal) or RAC (reflex auriculo-cardiale) method will be used both signals are the result of the micro-stress and vegetative reaction of the irradiated organism to the laser irradiation at the active points of the acupuncture. Acupuncture is performed in 2 sessions with an interval of one week and each session for 20 minutes with stimulation by Izar laser with diode radiation source, power 400 mW, wavelength 810 and specific frequency.The screening method will be performed with 24-item Iranian olfactory test. The olfactory test will be performed in 3 sessions: the first session (before the intervention), the second session (two weeks after the intervention) and the second session (three months after the intervention). Control group: For patients, in addition to betamethasone drops and acupuncture, laser off (placebo group) will be used. The percentage of people with a reduced sense of smell. Timepoint: Perform olfactory test before the intervention, 2 weeks after the intervention and three months after the intervention. Method of measurement: 24-item Iranian olfactory test. Iran University of Medical Sciences Approved 2021-03-07 Iran University of Medical Sciences Iran University of Medical Sciences Shahid Hemmat Highway,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)