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IRCT20210616051596N1 IRCT 2022-01-02 Shahre-kord University of Medical Sciences Evaluation of the effect of royal jelly on the side effects of methylprednisolone treatment Evaluation of the effect of Royal Jelly Capsule on reducing the side effects of methylprednisolone treatment in patients with COVID-19 2021-07-01 anticipated 60 Complete https://irct.ir/trial/56939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of participants to the control and intervention groups was performed using Random Allocation Software. Envelopes were prepared according to the number of participants in the study and were registered on the first envelope number one, the second envelope number 2, etc., and in each envelope, the allocation of each person determined using the mentioned software was placed. The order was opened with the arrival of each envelope for that person and according to the option in the envelope, the person was assigned to one of the intervention or control groups, Blinding description: Drugs and placebos are coded by the project manager. Randomization of patients in blocks is done only on the base of of hidden codes, and study participants, physicians, and nurses evaluating the results are blind to intervention and study groups. 3 Covid 19. Intervention 1: Control group: Receiving the standard diet They receive 50 mg of methylprednisolone ampoules daily + placebo (daily for 7 days). Intervention 2: Intervention group: Standard diet ampoules of methylprednisolone 50 mg daily + Royal gel capsules 1000 mg (daily for 7 days). Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. When: 2021-2022 To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: I have not decided yet Where to obtain: I have not decided yet How to obtain: I have not decided yet Comments:
public Hamidreza Pourfard
Parastar Aven.Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 hamidhrpus@gmail.com Shahre-kord University of Medical Sciences scientific Hamidreza Pourfard
Parastar Aven.Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 hamidhrpus@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients with positive PCR test who are treated with methylprednisolone. 18 years 60 years Both Patients with diabetes, immune deficiency acute bacterial infectious disease allergy to bee products U07.1 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Control group: Receiving the standard diet They receive 50 mg of methylprednisolone ampoules daily + placebo (daily for 7 days). Intervention group: Standard diet ampoules of methylprednisolone 50 mg daily + Royal gel capsules 1000 mg (daily for 7 days) Liver function factors (AST, ALT, ALKP, BILD, BILT). Timepoint: Daily. Method of measurement: Blood tet. Renal function factors (Na, K, Cr and BUN). Timepoint: Daily. Method of measurement: Blood test. Hematological factors (WBC, Hb, PLT). Timepoint: Daily. Method of measurement: Blood test. FBS. Timepoint: Daily. Method of measurement: Blood test. Dose and frequency of need for regular insulin (IR). Timepoint: Daily. Method of measurement: cheklist. Dosage and frequency of corticosteroids. Timepoint: daily. Method of measurement: cheklist. Clinical symptoms (chills, sore throat, abdominal pain, diarrhea, dyspnea, cough, shortness of breath). Timepoint: 7 day intervals. Method of measurement: Examination and questions. Inflammatory factors (ferritin and LDH). Timepoint: 7 day intervals. Method of measurement: Blood test. Disease severity. Timepoint: daily. Method of measurement: Need medical care, supportive oxygen, need mechanical ventilation. Spo2. Timepoint: Daily. Method of measurement: Oximetry. Duration of hospitalization. Timepoint: Duration of hospitalization due to Covid-19. Method of measurement: File review. Shahre-kord University of Medical Sciences Approved 2021-05-31 Ethics Committee of Shahrekord University of Medical Sciences Parastar Aven.Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)