Formulation of two natural products (syrup and solution) and evaluation of their effects in patients with coronavirus disease 2019 (COVID-19): A randomized controlled trial
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General information
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Full name of the responsible person in the three recruitment centers was changed from Amir Hossein Jamshidi to Nader Tavakoli
Full name of the responsible person in the three recruitment centers was changed from Amir Hossein Jamshidi to Nader Tavakoli
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نام فرد مسوول در هر سه مرکز بیمارگیری طرح از امیر حسین جمشیدی به نادر توکلی تغییر یافت
نام فرد مسوول در هر سه مرکز بیمارگیری طرح از امیر حسین جمشیدی به نادر توکلی تغییر یافت
Recruitment centers
#1
Name of recruitment center - English: Firoozgar general hospital
Name of recruitment center - Persian: مرکز آموزشی و درمانی فیروزگر
Full name of responsible person - English: Amir Hossein Jamshidi
Full name of responsible person - Persian: امیر حسین جمشیدی
Street address - English: Beh Afarin street, Karim Khan Zand street, Vali-e Asr sq. Tehran, Iran
Street address - Persian: تهران، میدان ولیعصر ، خیابان کریم خان ، خیابان به آفرین ، بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1000
Fax:
Email: h_firoozgar@yahoo.com
Web page address: https://firoozgar.iums.ac.ir/
Name of recruitment center - English: Firoozgar general hospital
Name of recruitment center - Persian: مرکز آموزشی و درمانی فیروزگر
Full name of responsible person - English: Nader Tavakoli
Full name of responsible person - Persian: نادر توکلی
Street address - English: Vice-Chancellor’s Office for Treatment, fourth floor, former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran
Street address - Persian: تهران، تقاطع خیابان جمهوری اسلامی و خیابان حافظ - طبقه چهارم معاونت درمان دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1134845764
Phone: +98 21 6670 7140
Fax:
Email: vct@iums.ac.ir
Web page address: https://iums.ac.ir/en?sid=26
Name of recruitment center - English: Firoozgar general hospital Name of recruitment center - Persian: مرکز آموزشی و درمانی فیروزگر Full name of responsible person - English: Amir Hossein JamshidiNader Tavakoli Full name of responsible person - Persian: امیر حسین جمشیدینادر توکلی Street address - English: Beh Afarin streetVice-Chancellor’s Office for Treatment, Karim Khan Zand streetfourth floor, Vali-e Asr sq.former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran, Iran Street address - Persian: تهران، میدان ولیعصر ،تقاطع خیابان کریم خان ،جمهوری اسلامی و خیابان به آفرین ، بیمارستان فیروزگرحافظ - طبقه چهارم معاونت درمان دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 15937478111134845764 Phone: +98 21 8214 10006670 7140 Fax: Email: h_firoozgarvct@yahoo.comiums.ac.ir Web page address: https://firoozgar.iums.ac.iriums.ac.ir/en?sid=26
#2
Name of recruitment center - English: Hazrate Rasoole Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Amir Hossein Jamshidi
Full name of responsible person - Persian: امیرحسین جمشیدی
Street address - English: Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Av
Street address - Persian: خیابان ستارخان، خیابان نیایش، بیمارستان حضرت رسول اکرم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 4496 1453
Fax:
Email: hrmc@iums.ac.ir
Web page address: https://hrmc.iums.ac.ir/
Name of recruitment center - English: Hazrate Rasoole Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Nader Tavakoli
Full name of responsible person - Persian: نادر توکلی
Street address - English: Vice-Chancellor’s Office for Treatment, fourth floor, former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran
Street address - Persian: تهران، تقاطع خیابان جمهوری اسلامی و خیابان حافظ - طبقه چهارم معاونت درمان دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1134845764
Phone: +98 21 6670 7140
Fax:
Email: vct@iums.ac.ir
Web page address: https://iums.ac.ir/en?sid=26
Name of recruitment center - English: Hazrate Rasoole Akram Hospital Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم Full name of responsible person - English: Amir Hossein JamshidiNader Tavakoli Full name of responsible person - Persian: امیرحسین جمشیدینادر توکلی Street address - English: Hazrate Rasoole Akram HospitalVice-Chancellor’s Office for Treatment, Niayesh Stfourth floor, Satarkhan Avformer building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran Street address - Persian: خیابان ستارخانتهران، تقاطع خیابان نیایش، بیمارستان حضرت رسول اکرمجمهوری اسلامی و خیابان حافظ - طبقه چهارم معاونت درمان دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14496145351134845764 Phone: +98 21 4496 14536670 7140 Fax: Email: hrmcvct@iums.ac.ir Web page address: https://hrmc.iums.ac.iriums.ac.ir/en?sid=26
#3
Name of recruitment center - English: Shohadaye Haft-e Tir Hospital
Name of recruitment center - Persian: بیمارستان شهدای هفتم تیر
Full name of responsible person - English: Amir Hossein Jamshidi
Full name of responsible person - Persian: امیر حسین جمشیدی
Street address - English: Shohadaye Haft-e Tir Hospital, Shahr-e Rey crossroad, Shahid Rajaie Street, Tehran
Street address - Persian: تهران، انتهای خیابان شهیدرجائی، سه راهی شهرری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1886718136
Phone: +98 21 5522 8581
Fax: +98 21 5521 7901
Email: web7tir@iums.ac.ir
Web page address: https://hospht.iums.ac.ir/
Name of recruitment center - English: Shohadaye Haft-e Tir Hospital
Name of recruitment center - Persian: بیمارستان شهدای هفتم تیر
Full name of responsible person - English: Nader Tavakoli
Full name of responsible person - Persian: نادر توکلی
Street address - English: Vice-Chancellor’s Office for Treatment, fourth floor, former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran
Street address - Persian: تهران، تقاطع خیابان جمهوری اسلامی و خیابان حافظ - طبقه چهارم معاونت درمان دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1134845764
Phone: +98 21 6670 7140
Fax:
Email: vct@iums.ac.ir
Web page address: https://iums.ac.ir/en?sid=26
Name of recruitment center - English: Shohadaye Haft-e Tir Hospital Name of recruitment center - Persian: بیمارستان شهدای هفتم تیر Full name of responsible person - English: Amir Hossein JamshidiNader Tavakoli Full name of responsible person - Persian: امیر حسین جمشیدینادر توکلی Street address - English: Shohadaye HaftVice-e Tir HospitalChancellor’s Office for Treatment, Shahr-e Rey crossroadfourth floor, Shahid Rajaie Streetformer building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran Street address - Persian: تهران، انتهایتقاطع خیابان شهیدرجائی، سه راهی شهرریجمهوری اسلامی و خیابان حافظ - طبقه چهارم معاونت درمان دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 18867181361134845764 Phone: +98 21 5522 85816670 7140 Fax: +98 21 5521 7901 Email: web7tirvct@iums.ac.ir Web page address: https://hospht.iums.ac.iriums.ac.ir/en?sid=26
Protocol summary
Study aim
Formulation of two natural products (syrup and solution) and evaluation of their efficacy and safety in COVID-19 patients
Design
This is a parallel 2-arm randomized, controlled, double-blind, single center study. 70 patients are enrolled and followed for 14 days
This study is a multi-center randomized, controlled, double-blind clinical trial with two parallel arms. 150 patients will be enrolled in the study and followed for 10 days.
Settings and conduct
This study will be carried out in some Iran University of Medical Sciences hospitals.
In the intervention group, 75 patients with COVID-19, in addition to standard recommended treatment, receive Crostop solution and Croguard syrup three times daily for 10 days. Also, 75 patients in the control group receive only the standard recommended treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-65 years old participants who highly suspected or confirmed cases of COVID-19 infection;
Exclusion criteria: History of drug allergy
Uncontrolled diseases including neuropsychiatric disorders, thyroid disorders, heart disease
Pregnancy; Breastfeeding
Renal or liver failure
Intervention groups
Intervention group in addition to receiving the standard treatment recommended by the National Committee, will receive Crostop solution 10 cc three times daily and Croguard syrup 30 cc three times daily for 10 days.
Patients in the control group will receive only the standard treatment.
Main outcome variables
Significant clinical recovery (composite): Clinical recovery up to 10 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (>94% on room air), and alleviation of cough (mild or absent on a patient reported scale), sustained for at least 24 hours.
General information
Reason for update
Full name of the responsible person in the three recruitment centers was changed from Amir Hossein Jamshidi to Nader Tavakoli
Acronym
IRCT registration information
IRCT registration number:IRCT20200316046792N1
Registration date:2020-03-17, 1398/12/27
Registration timing:registered_while_recruiting
Last update:2020-03-24, 1399/01/05
Update count:1
Registration date
2020-03-17, 1398/12/27
Registrant information
Name
Amir Hossein Jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9666
Email address
jamshidi.ah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-16, 1398/12/26
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation of two natural products (syrup and solution) and evaluation of their effects in patients with coronavirus disease 2019 (COVID-19): A randomized controlled trial
Public title
Effect of herbal syrup and solution in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory-confirmed COVID-19 cases (2019-nCoV Real-Time RT-PCR ), regardless of the clinical manifestations and history of close contact
Both the men and women, aged between 18 to 65 years old
Signing informed written consent
Highly suspected cases of COVID-19 based on positive findings of chest CT scan
Exclusion criteria:
5 days or more after the onset of illness
Pregnancy
Breastfeeding
History of drug allergy
Complicated cases with bacterial infection
Patients in recovery phase
Critical and severe cases such as ARDS
Clinical evidence for respiratory insufficiency at the time of hospitalization (SaO2 ≤90% or PaO2 < 8 kPa) in the patient breathing room air without oxygen therapy
Comorbidities (e.g. renal failure, liver failure, CHF, cerebrovascular and cardiovascular major diseases, chronic pulmonary disease, malignancy, endocrine and metabolic diseases, any immunodeficiency disorders such as AIDS, encephalopathy, neuropathy )
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized in a 1:1 ratio into one of the treatment groups and standard of care group using computer generated randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes and the statistician analyzing the data all will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.IUMS.REC.1398.1399
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
Response to the treatment (Significant clinical improvement)
Timepoint
At baseline and on the third, fifth, seventh, and tenth days after starting the treatment
Method of measurement
According to the clinical, paraclinical and laboratory findings. Clinical improvement: normalization of the body temperature (≤37.2 ° C), respiratory rate (≤24 breaths per minute), oxygen saturation (> 94% at room temperature) and cough (zero or mild) that persist for at least 24 hours. Cough will measure on a qualitative scale based on the patient's report . Other outcome variables will measure during clinical examination
2
Description
Complications of the treatment
Timepoint
Daily, until the tenth day
Method of measurement
Interview and patient's record
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
End of the treatment
Method of measurement
Patient's medical record
2
Description
Mortality
Timepoint
End of the treatment
Method of measurement
Patient's medical record (Clinical outcome)
Intervention groups
1
Description
Intervention group: Hospitalized patients will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee.
Category
Treatment - Drugs
2
Description
Control group: Hospitalized patients will receive standard treatment according to the national guidelines for the treatment of COVID-19
Category
Treatment - Drugs
3
Description
Intervention group: Outpatients (self-quarantine at their home) will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar general hospital
Full name of responsible person
Nader Tavakoli
Street address
Vice-Chancellor’s Office for Treatment, fourth floor, former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6670 7140
Email
vct@iums.ac.ir
Web page address
https://iums.ac.ir/en?sid=26
2
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Nader Tavakoli
Street address
Vice-Chancellor’s Office for Treatment, fourth floor, former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6670 7140
Fax
Email
vct@iums.ac.ir
Web page address
https://iums.ac.ir/en?sid=26
3
Recruitment center
Name of recruitment center
Shohadaye Haft-e Tir Hospital
Full name of responsible person
Nader Tavakoli
Street address
Vice-Chancellor’s Office for Treatment, fourth floor, former building of the Ministry of Health and Medical Education, at the Intersection of Jomhuri and Hafez Streets, Tehran
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6670 7140
Fax
Email
vct@iums.ac.ir
Web page address
https://iums.ac.ir/en?sid=26
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
144961455
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
http://www.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Amir Hossein Jamshidi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9666
Fax
+98 21 5561 3191
Email
jamshidi.ah@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Hossein Jamshidi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9666
Fax
+98 21 5561 3191
Email
jamshidi.ah@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amirhossein Jamshidi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Iranian Medicine, No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5561 3190
Fax
+98 21 5561 3191
Email
jamshidiam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
The study results will be published. Also the study protocol and statistical analysis will be considered.
When the data will become available and for how long
One year after completion of the study, data will be published and available
To whom data/document is available
With the financial backing permission, data may be made available to the physicians and academic researchers and institutions.
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and metaanalysis
From where data/document is obtainable
For this you may ask Amirhossein Janshidi through jamshidiam@yahoo.com
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks