Evaluation of the effects of violet syrup on the recovery of outpatient coronary patients
Design
A double-blind, with placebo, randomized clinical trial with 4 blocks, phase 3, 100 patients, Stata software was used for randomization.
Settings and conduct
Patients referred to Al-Zahra Hospital (Isfahan Corona Center) for whom the diagnosis of COVID-19 was confirmed based on clinical symptoms and blood oxygen saturation percentage along with lung CT scan with the approval of a Radiologist and / or positive PCR, did not require hospitalization, outpatient medical and protective treatment.
Patients and physician are unaware of the group allocation.
Participants/Inclusion and exclusion criteria
Patients based on clinical signs and the percentage of oxygen saturation in the blood with CT scan of the lung with the approval of a radiologist and / or PCR confirmed for them and do not need to be hospitalized, to be treated on an outpatient basis for medical and conservative treatment
Saturated oxygen pressure greater than or equal to 90%
Age range of patients 15 to 75 years in both sexes
Diabetic patients, has diarrhea, people with a history of allergies to herbal products and medicines are not included in the study
Intervention groups
Intervention group receive study drug in addition to usual drugs.
Control group receive placebo with the usual drugs
Main outcome variables
Improving the patient's clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190409043215N2
Registration date:2021-02-14, 1399/11/26
Registration timing:registered_while_recruiting
Last update:2021-02-14, 1399/11/26
Update count:0
Registration date
2021-02-14, 1399/11/26
Registrant information
Name
Ali akbar Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 3176
Email address
safaria@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Viola odorata syrup on aleviating the manifestations of COVID-19 (Corona) infection: A double-blind placebo controlled trial
Public title
Effect of Viola odorata syrup on aleviating the manifestations of COVID-19 (Corona) infection: A double-blind placebo controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Al-Zahra Hospital (Isfahan) who diagnosed COVID-19 based on clinical symptoms and blood oxygen saturation along with CT scan of the lung with the approval of a radiologist and / or positive PCR for them.
Blood oxygen saturation greater than or equal to 90%.
The age range of patients is 15 to 75 years
Both sexes
Satisfaction to participate in the study
Exclusion criteria:
Diabetic patients
Patients with allergies to herbal products
Severe forms of covid-19 disease (respiratory rate> 24 or percnt of blood saturated oxygenation <90%)
Patients with diarrhea
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization technique with 4 blocks. Using Stata software random number chains from 1 to 6 to reach the desired sample size was produced. Prepared random assignment sequences for individuals was placed in sealed envelopes (Sealed) and numbered with a 5-digit serial number, by a third party who did not play a role in the design of the study. All envelopes (100 envelopes) have a random dedicated serial number that was immediately
opened after completing basic information and basic tests to allocate individuals to groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs were coded so participant, clinician and therapist were unaware of their content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Medicine, Tehran University of Medical Sciences
Street address
Medical School, Poursina St, Ghods St, Enghelab St, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.784
2
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences, School of Medicine
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-03, 1399/11/15
Ethics committee reference number
IR.MUI.MED.REC.1399.1022
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Severity of shortness of breath
Timepoint
Once a day for 6 days
Method of measurement
Questionary
2
Description
Intensity of cough
Timepoint
Once a day for 6 days
Method of measurement
Questionnaire
3
Description
Blood oxygen
Timepoint
Once a day for 6 days
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: recipient of violet syrup, in the amount of 10 ml three times a day for 5 days. Violet syrup contains aqueous extract of violet flowers and leaves and sugar, which has a manufacturing license from the Food and Drug Administration, number 6599807159453166.
Category
Treatment - Drugs
2
Description
Control group: receiving placebo syrup, in the amount of 10 ml three times a day for 5 days. Placebo syrup contains water, sugar and a little food coloring to look like medicine.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital (Isfahan)
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Street address
Al-Zahra Educational and Medical Center, Soffeh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
sadeghadel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technologycorner, Corner of Ghods Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Covid 19 Research Grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Scinces
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Barij Essence Pharmaceutical Company
Full name of responsible person
Leila Mohammad Taghizadeh
Street address
No. 78, Marzdaran St., between Ariafar and Sarsabz
City
Tehran
Province
Tehran
Postal code
1464653465
Phone
+98 21 4421 2044
Fax
+98 86 4446 5187
Email
kashanileila138@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Pharmaceutical Company
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meysam Shirzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27,Sarparast St, Taleghani St
City
Tehran
Province
Tehran
Postal code
1464653465
Phone
+98 21 8897 4535
Fax
Email
shirzadmd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meysam Shirzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Sarparast St, Taleghani St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 4535
Email
shirzadmd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Akbar Safari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
45 meters Golshahr Street, Shahid Saffarian Street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
safariali1350@yahoo.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
Yes - There is 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
Clinical study report
When the data will become available and for how long
After completing the study
To whom data/document is available
working at the University
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Ali akbar safari
What processes are involved for a request to access data/document