The effect of Royal Jelly Capsule on reducing the side effects of methylprednisolone treatment in COVID-19 patients
Design
In this study, individuals are divided into two groups of intervention 30 and control 30 by random sampling.
The first group of the standard diet of ampoules of methylprednisolone 50 mg daily + Royal gel capsules 1000 mg (daily for 7 days)
The second group receives the standard diet of ampoules of methylprednisolone 50 mg daily + placebo (daily for 7 days).
Blood sugar is also recorded by a glucometer every 8 hours. If the blood sugar rises, the dose and frequency of insulin injections are recorded.
Settings and conduct
60 patients with Covid-19 with positive PCR test and lung involvement are divided into two groups of intervention and control of 30 people. first group receives corticosteroid therapy and Royal Jelly capsules 1000 mg daily for 7 days and the second group receives corticosteroid therapy and placebo.
Participants/Inclusion and exclusion criteria
Inclusion : Patients with positive PCR test under methylprednisolone treatment
Exclusion: diabetes, immune deficiency, acute bacterial infectious disease, allergy to bee products
Intervention groups
The first group of the standard diet of ampoules of methylprednisolone 50 mg daily + Royal gel capsules 1000 mg (daily for 7 days)
The second group receives the standard diet of ampoules of methylprednisolone 50 mg daily + placebo (daily for 7 days).
Main outcome variables
Blood tests, dose and frequency of insulin and corticosteroids, daily spo2 and severity of disease, weekly clinical signs and inflammatory factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210616051596N1
Registration date:2022-01-02, 1400/10/12
Registration timing:retrospective
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Hamidreza pourfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
pourfard.h@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Royal Jelly Capsule on reducing the side effects of methylprednisolone treatment in patients with COVID-19
Public title
Evaluation of the effect of royal jelly on the side effects of methylprednisolone treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive PCR test who are treated with methylprednisolone.
Exclusion criteria:
Patients with diabetes,
immune deficiency
acute bacterial infectious disease
allergy to bee products
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.SKUMS.REC.1400.063
Health conditions studied
1
Description of health condition studied
Covid 19
ICD-10 code
U07.1
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Liver function factors (AST, ALT, ALKP, BILD, BILT)
Timepoint
Daily
Method of measurement
Blood tet
2
Description
Renal function factors (Na, K, Cr and BUN)
Timepoint
Daily
Method of measurement
Blood test
3
Description
Hematological factors (WBC, Hb, PLT)
Timepoint
Daily
Method of measurement
Blood test
4
Description
FBS
Timepoint
Daily
Method of measurement
Blood test
5
Description
Dose and frequency of need for regular insulin (IR)