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Recruitment centers
#1
Name of recruitment center - English: University of Medical Sciences and affiliated medical centers - Tehran, Rasht, Ahvaz and Kashan
Name of recruitment center - Persian: دانشگاه علوم پزشکی و مراکز درمانی تابعه – تهران ، رشت ، اهواز و کاشان
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Street address - English: Ghotb Ravandi Blvd, Kashan University of Medical Sciences
Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax: +98 31 5557 5057
Email: research@kaums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Beheshti Hospital, Kashan
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Mohammad Kazem Sayah
Full name of responsible person - Persian: محمد کاظم سیاح
Street address - English: Ghotb Ravandi Blvd, Shahid Beheshti Hospital
Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0026
Fax: +98 31 5554 8900
Email: beheshtihospital@kaums.ac.ir
Web page address:
Name of recruitment center - English: University of Medical Sciences and affiliated medical centers - TehranShahid Beheshti Hospital, Rasht, Ahvaz and Kashan Name of recruitment center - Persian: دانشگاه علوم پزشکی و مراکز درمانی تابعه – تهران ، رشت ، اهواز وبیمارستان شهید بهشتی کاشان Full name of responsible person - English: Morteza KosariMohammad Kazem Sayah Full name of responsible person - Persian: مرتضی کوثریمحمد کاظم سیاح Street address - English: Ghotb Ravandi Blvd, Kashan University of Medical SciencesShahid Beheshti Hospital Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 871598814187159/81151 Phone: +98 31 5554 29990026 Fax: +98 31 5557 50575554 8900 Email: researchbeheshtihospital@kaums.ac.ir Web page address:
#2
Name of recruitment center - English: بیمارستان رازی رشت
Name of recruitment center - Persian: Razi Hospital, Rasht
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Street address - English: Sardar Jang al Street , Razi Hospital, Rasht Town
Street address - Persian: خیابان سردار جنگل- بیمارستان رازی رشت
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 41448
Phone: +98 13 3354 1001
Fax: +98 13 3355 9787
Email: razi.hospital@yahoo.com
Web page address:
Name of recruitment center - English: Al-Zahra Hospital, Isfahan
Name of recruitment center - Persian: بیمارستان الزهرا (س) اصفهان
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Street address - English: Al-Zahra Hospital , sofeh Blvd, Shahid Keshvari Highway , IsfahanBlvd, Shahid Keshvari Highway , Isfahan
Street address - Persian: اصفهان ، بزرگراه شهید کشوری ، بلوار صفه ، بیمارستان الزهرا ( س )
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 31 3668 5555
Fax:
Email: alzahra@mui.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان رازی رشتAl-Zahra Hospital, Isfahan Name of recruitment center - Persian: Razi Hospital, Rashtبیمارستان الزهرا (س) اصفهان Full name of responsible person - English: Morteza Kosari Full name of responsible person - Persian: مرتضی کوثری Street address - English: Sardar Jang al StreetAl-Zahra Hospital , Razi Hospitalsofeh Blvd, Rasht TownShahid Keshvari Highway , IsfahanBlvd, Shahid Keshvari Highway , Isfahan Street address - Persian: خیابان سردار جنگل-اصفهان ، بزرگراه شهید کشوری ، بلوار صفه ، بیمارستان رازی رشتالزهرا ( س ) City - English: RashtIsfahan City - Persian: رشتاصفهان Province: GuilanIsfehan Country: Iran (Islamic Republic of) Postal code: 414488174675731 Phone: +98 13 3354 100131 3668 5555 Fax: +98 13 3355 9787 Email: razi.hospitalalzahra@yahoo.commui.ac.ir Web page address:
#3
Name of recruitment center - English: Razi Hospital of Ahvaz
Name of recruitment center - Persian: بیمارستان رازی اهواز
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Street address - English: Palestine Street, in front of the Governorate, Razi Hospital ,Ahvaz ُTown
Street address - Persian: خیابان فلسطین-روبروی فرمانداری-بیمارستان رازی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6196514941
Phone: +98 61 3333 5935
Fax:
Email: info@ajums.ac.ir
Web page address:
Name of recruitment center - English: Razi Hospital of Ahvaz Name of recruitment center - Persian: بیمارستان رازی اهواز Full name of responsible person - English: Morteza Kosari Full name of responsible person - Persian: مرتضی کوثری Street address - English: Palestine Street, in front of the Governorate, Razi Hospital ,Ahvaz ُTown Street address - Persian: خیابان فلسطین-روبروی فرمانداری-بیمارستان رازی اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6196514941 Phone: +98 61 3333 5935 Fax: Email: info@ajums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamidreza Banafsheh
Full name of responsible person - Persian: research@kaums.ac.ir
Street address - English: Ghotb Ravandi Blvd, Kashan University of Medical Sciences
Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax: +98 31 5557 5057
Email: research@kaums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamidreza Banafsheh
Full name of responsible person - Persian: دکتر حمید رضا بنفشه
Street address - English: Ghotb Ravandi Blvd ,Kashan University of Medical Sciences
Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax: +98 31 5557 5057
Email: research@kaums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Hamidreza Banafsheh Full name of responsible person - Persian: research@kaums.ac.irدکتر حمید رضا بنفشه Street address - English: Ghotb Ravandi Blvd,Kashan University of Medical Sciences Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان City - English: kashanKashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 2999 Fax: +98 31 5557 5057 Email: research@kaums.ac.ir Web page address:
Protocol summary
Study aim
The effect determination of Hyoscyamus niger-extracted methanolic extract with propolis on blood factors and clinical symptoms in patients with covid-19
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 is performed on 90 patients.
Patients with terminated block randomization with 4 and 6 blocks are divided into two groups of intervention and placebo.
Settings and conduct
The study is performed in hospitalized patients with covid-19. In this study, patients are randomly divided into intervention group including patients receiving the product with routine drugs and placebo group including patients receiving placebo with routine drugs.
The treatment will be done in the form of syrup with specific labels during 6 days of study.
Participants/Inclusion and exclusion criteria
The status of entry:
Patients should be exposed to covid-19.
The patient must have a voluntary and consciously consent because to participate in trail.
The status of no entry:
Patients with heart and mental problems and pregnant women
The exit status of study:
The dissatisfaction of patient for staying in the study or having side complications impressive on patient's health
Intervention groups
The herbal product is given to the patient in syrup form amount 60 CC with specific labels.
The patient's daily intake is mount 30 CC per day. The patient receives 10 CC equivalent to one tablespoon of syrup every 8 hours.
The syrup is enough for 2 days and the patient will be given new syrups within six days of studying.
Main outcome variables
The evaluation of clinical symptoms such as fever, cough, shortness of breath, etc.
The assessment of blood factors CBC, ESR and CRP
The comparison of heart beat number, blood pressure, body temperature and number of breaths per minute, percentage of blood oxygen saturation and number of days requiring oxygen adjuvant therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047462N2
Registration date:2020-07-17, 1399/04/27
Registration timing:registered_while_recruiting
Last update:2020-10-24, 1399/08/03
Update count:3
Registration date
2020-07-17, 1399/04/27
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
2020-07-08, 1399/04/18
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness comparison of Hyoscyamus niger methanolic extract and propolis in the treatment of patients with covid-19
Public title
The effect of hyoscyamus niger with propolis on covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute respiratory labeling (ARI) with 2-fold reduction under control: RR> 30; 85% <PO2 <93%; Chest floor Pulmonary infiltration; Clinical judgment of a specialist
Age range 18 to 75 years of both sexes
The patient does not have any serious concurrent cardiovascular and cerebral diseases
The patient's ability and personal desire to fill out a personal consent form to enter the study
Exclusion criteria:
History of heart disease, mental disease and pregnant women
Existence of any history of allergy to any of the components of the herbal product
Nausea and vomiting and intolerance to food
Resistant hypoxemia and decreased level of consciousness
Hemodynamic instability
Hypercapnia - Respiratory fatigue
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two groups by terminated block randomization method with blocks of 4 and 6, prescription drugs (intervention and placebo) are determined based on this method and a special number is assigned to them.
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
Kashan University of Medical Sciences, Ghotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
55578011
Approval date
2020-07-08, 1399/04/18
Ethics committee reference number
IR.KAMUS.REC.1399.016
Health conditions studied
1
Description of health condition studied
Coronavirus
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
The comparison of the symptoms such as fever, dry cough, diarrhea, vomiting, sore throat, sore throat and larynx, abdominal pain and chest pain, nausea, chills and anorexia
Timepoint
The hypotheses are tested at the beginning of the study and on the second, fourth, and sixth days of treatment
Method of measurement
Questionnaire and observation
2
Description
Comparison of blood factors CBC, ESR and CRP
Timepoint
The hypotheses are tested at the beginning of the study and on the second, fourth, and sixth days of treatment
Method of measurement
Biochemical factors measured in a clinical laboratory
3
Description
Comparison of heart rate, blood pressure and body temperature
Timepoint
The hypotheses are tested at the beginning of the study and on the second, fourth, and sixth days of treatment
Method of measurement
Pressure gauge and thermometer
4
Description
Comparison of respiration rate per minute, percentage of blood oxygen saturation and number of days requiring adjuvant oxygen therapy
Timepoint
The hypotheses are tested at the beginning of the study and on the second, fourth, and sixth days of treatment
Method of measurement
Pulse Oximeter
5
Description
Evaluation of drug side effects
Timepoint
Days of the first, second and fourth, sixth days after the start of treatment between the intervention and control groups
Method of measurement
View and questionnaire and ...
6
Description
Comparison of the status of withdrawal from the continuation of the study
Timepoint
After starting treatment between the intervention and control groups
Method of measurement
View and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal product including methanolic extract of seeds and propolis is prepared in the form of 60 cc syrup and this amount of syrup is prepared for two days of the patient and the patient drinks 10 cc of syrup three times a day for six days and each time. Receives. During 6 days of study, three bottles of 60 cc syrup will be provided to the patient.
Category
Treatment - Drugs
2
Description
Control group: Syrup for six days and daily in three times and each time 10 cc of syrup without plant products is given to the patient in the form of ordinary water syrup. The syrup in the amount of 60 cc is prepared for the patient for two days and is given to the patient after the syrup is finished. The second and third syrups are given to the patient for consumption during six days of study.