The effect of methanolic extract of hyoscyamus niger containing steroidal glycosides with propolis in patients with acute respiratory infection (infection or suspected covid-19): A clinical trials
The effect determination of bergamot seeds-extracted methanolic extract containing steroidal glycosides with propolis for treatment of patients with acute respiratory infection including patients with or suspected of covid-19 into clinical trial
Design
- The testing process is two-headed blind, meaning that 25 patients receive the product (dried methanolic extract with propolis) and another 25 patients receive placebo. Physician and patient have not information about received medicine and patients receiving placebo are also placebo.
Settings and conduct
Outpatients in Kashan Akhavan Clinic and 16-hour centers of Sepehri and Shahid Beheshti Hospital, Kashan University of Medical Sciences, Kashan, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who, in addition to acute respiratory illness.
2. The patient's ability and its personal desire to fill out of personal consent form to enter the study
Output Criteria:
1. Pregnancy and lactation
2. Heart and mental patients
Intervention groups
Patients with acute respiratory infection (covid-19 suspected or suspected)
Main outcome variables
Clinical symptoms include dry cough, shortness of breath, fever and chills.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047462N1
Registration date:2020-05-17, 1399/02/28
Registration timing:registered_while_recruiting
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
morteza kosari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 6622
Email address
yeganehbadi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-06, 1399/02/17
Expected recruitment end date
2020-06-06, 1399/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of methanolic extract of hyoscyamus niger containing steroidal glycosides with propolis in patients with acute respiratory infection (infection or suspected covid-19): A clinical trials
Public title
Intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient must have a voluntary consent to participate in operation; The patient's clinical symptoms such as: dry cough, shortness of breath, fever, shortness of breath, fatigue, etc. in suspected or associated with COVID-19 is evaluated after treatment and these symptoms are compared with placebo group.
Exclusion criteria:
Heart patients, mental patients and pregnant women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After acceptance and registration, these samples are entered in study by physician and nurse of clinic and also project manager based on the entry and exit criteria. The samples are divided into two groups by method of terminated block randomization with blocks 4 and 6. Prescriptive drugs (intervention and placebo) are determined based on this method with a special number to them. Physician and patient are not aware of intervention type and the patient's assignment to each treatment will be assign randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on syrup and only the epidemiologist informs as a plan executor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
55578011
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.KAMUS.REC.1399.001
Health conditions studied
1
Description of health condition studied
covid 19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Shortness of breath, medicine, dry cough, chills and etc.
Timepoint
May and June
Method of measurement
Quantitative and qualitative
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Products containing 10 mg of methanolic extract plus 450 mg of propolis will be prescribed three times a day for each patient. This amount of active ingredients is dissolved in 30cc of simple BP syrup. This 30 cc is ordered in 10cc (one tablespoon) every 8. The time will be prescribed. The formulated syrup will be given to the patients in the amount of 60 cc required by the above-mentioned order for 2 days and the patients will go to the clinic every two days after receiving the medicine again, the questionnaire and clinical symptoms will be referred to the clinic. In addition, suspected patients with covid 19 will be delivered to patients after the approval of an infectious disease specialist and, if the patient agrees, and will receive a signature and fingerprint in the syrup consent form. Prescribing syrup and examining the patient's symptoms are 6 days.
Category
Treatment - Drugs
2
Description
Control group: Simple BP syrup (without therapeutic products) will be prescribed every 10 hours with a 10cc (one tablespoon) recipe. Two days later, the drug will be returned to the clinic, a questionnaire and clinical signs will be sent to the clinic. In addition, suspected patients with covid 19 will be delivered to patients after the approval of an infectious disease specialist and, if the patient agrees, and will receive a signature and fingerprint in the syrup consent form. Prescribing syrup and examining the patient's symptoms are 6 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Clinic, Sepehri 16-hour Center, Shahid Beheshti Hospital
Full name of responsible person
Morteza Kosari
Street address
Ghotb Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotb Ravandi
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 16, Hakim Alley. , Montazeri St. , Badrod Town
City
Isfahan
Province
Isfehan
Postal code
8766113894
Phone
+98 31 5434 6622
Email
kosarimorteza12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 16, Hakim Alley., Montazeri St. , Badrod Town
City
Badrod
Province
Isfehan
Postal code
8766113894
Phone
+98 31 5434 6622
Email
kosarimorteza12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 16, Hakim Alley. , Montazeri St. , Badrod Town
City
Badrod
Province
Isfehan
Postal code
8766113894
Phone
+98 31 5434 6622
Email
kosarimorteza12@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available