Evaluation of changes in CRP levels, serum lymphocyte levels and inflammatory factors and clinical factors including cough, fever and shortness of breath (oxygenation of cure) in patients with Qovid-19 under treatment with oral Bromelain and Montelukast
Design
This study was following oral administration of Bromelain and Montelukast separately and concomitantly in patients with Couvid-19 accepted in the emergency department of Hospital. In this study, which is performed in phase 0 of the clinical trial, 60 patients with Quaid 19 accidentally (Based on client code number and patient code tracking) were divided into three control groups (20) and sample 1 (20). ) And samples 2 (20) were divided.
Settings and conduct
This project will be implemented in Masih Daneshvari Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Infected patients with coronavirus new virus referred to the hospital emergency department
Intervention groups
In group 1 (20 patients), patients were prescribed one Anaheal capsule containing 200 mg of Bromelain every 8 hours (one hour before or after a meal). In group 2 (20 patients), one Anaheal capsule containing 200 mg of Bromelain every 8 hours (one hour before or after a meal) and one Montelukast 10 mg tablet 1 hour before or after dinner were given to patients. Was designated. In the control group (20 patients), the placebo capsule was used at exactly the same intervals.
Main outcome variables
Inflammatory factors, immunological factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150725023332N3
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2283 1058
Email address
alirezajahangiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Bromelain and Montelukast on Clinical and non-Clinical parameters in Covid-19 patients
Public title
The effect of Bromelain and Montelukast in Covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infection with coronavirus is new
Exclusion criteria:
History of severe liver disease
History of severe respiratory disorders
BMI <12
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed in a simple and individual manner with emphasis on the case file of the referring patients and using a table of random numbers. In this method, all patients were coded and randomly assigned the code of each disease to a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences, Masih Daneshvari Hospital
Before intervention , 1 hour later, 6 hours later and 12 hours after the intervention
Method of measurement
Biochemical and immunological tests
2
Description
CRP
Timepoint
Before intervention , 1 hour later, 6 hours later and 12 hours after the intervention
Method of measurement
Biochemical test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group 1, an Anaheal capsule (Parmon Amin Health Company) containing 200 mg of Bromelain was given to patients every 8 hours (one hour before or after a meal).
Category
Treatment - Drugs
2
Description
Intervention group: In Group 2, an Anahil capsule (Parmon Amin Health Company) containing 200 mg of Bromelain was given to patients every 8 hours (one hour before or after a meal) and a 10 mg montelukast tablet 1 hour before or after dinner.
Category
Treatment - Drugs
3
Description
Control group: In the control group, placebo capsules were used exactly at the above intervals
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Alireza Jahangirifard
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout