Evaluation of the effects of the aqueous extract of Alhagi papilionaceae or petals Saffron petal and mountain tea herbs on the clinical and paraclinical symptoms of COVID-19 patients
Evaluation of the effects of the aqueous extract of Alhagi papilionaceae or petals Saffron petal and mountain tea herbs on the clinical and paraclinical symptoms of COVID-19 patients
Design
Clinical trial with control group, double blind, randomized, phase 2on 40 patients. With the help of a statistician as well as the use of appropriate software (probably SAS Version 9.2 (SAS institute Inc., Cary, NC))
Settings and conduct
Blood samples will be collected from patients. Liver and kidney function are assessed in patients. Includes assessment of length of hospital stay, mortality rate, and pulmonary infiltration rate based on X-ray or CT scan of the lungs. It will be prescribed to patients by a doctor and will be performed in Ali Ibn Abitaleb Hospital in Rafsanjan
Participants/Inclusion and exclusion criteria
Inclusion criteria in this study included all patients in whom Covid 19 infection was confirmed. Exclusion criteria included patients with other infections or diseases such as influenza, pulmonary insufficiency, ARDS pneumonia and other cold symptoms.
Intervention groups
The intervention group includes patients with COVID-19 who receive herbal compounds (including aqueous extract of Ador-Cancer, saffron petals and mountain tea).
The control group includes patients with COVID-19 who receive placebo
Main outcome variables
Duration of hospitalization of patients with Covid-19
Mortality rate of patients with Covid-19
Pulmonary infiltration rate in patients with Covid-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211108053002N1
Registration date:2021-11-21, 1400/08/30
Registration timing:prospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
ALI darehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3131 5000
Email address
adarehkordi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of the aqueous extract of Alhagi papilionaceae or petals Saffron petal and mountain tea herbs on the clinical and paraclinical symptoms of COVID-19 patients
Public title
Evaluation of the effect of plant compounds extract (including aqueous extract of Ador-Cancer, saffron petals and mountain tea) in patients with coronary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria in this study include all patients who have been diagnosed with Covid 19 infection and do not have other infections or diseases such as influenza, pulmonary insufficiency, ARDS pneumonia and other cold symptoms, as well as files with complete data. Consciously taken from patients.
Exclusion criteria:
Exclusion criteria included patients who had other infections or diseases such as influenza, pulmonary insufficiency, ARDS pneumonia and other cold symptoms and the result of Qovid 19 infection is negative. Also, files with incomplete data will be removed from this study. Obviously, conscious dissatisfaction also leads to exclusion from the study. Patients who were hospitalized and their clinical condition was deteriorating were excluded from the study and lung CT scans were obtained from patients. Patients with oxygen levels less than 93 mm Hg were excluded from the study
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description: Simple randomization
Randomization unit: individual
Randomization tool: Excel software
How to build a random sequence: Using the Excel Rand function
Hide: In order to hide random allocation, the method of SNOSE will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Thus, drug and placebo syrups will be prepared in one form and one form and will be prescribed to patients by the doctor. Syrups have codes that neither the doctor nor the researcher knows about. Also, data collection is done by a researcher who does not know the divided group. In addition, the people who will analyze the data will be unaware of the content of the groups. Thus, neither the patient, nor the researcher, nor the physician, nor the data analyst will know the content of the groups. Patients are also asked not to talk about their treatment with other patients. The patient code will be opened only in emergency situations and when the possible side effects of taking the drug make it necessary to change the treatment protocol. Data entry software will be locked so data access or change will not be possible.
Monitoring and control
An independent supervisor will be asked to check all questionnaires and make sure the consent forms are signed. Also, a number of patients will be randomly selected and asked about the treatment protocol.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Medical Sciences
Street address
Persian Gulf Boulevard - Pistachio Boulevard - Campus of Molecular Medical Research Center
City
rafsanjan
Province
Kerman
Postal code
7718175911
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.RUMS.REC.1400.097
Health conditions studied
1
Description of health condition studied
symptoms of COVID-19 patients
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
The length of hospitalization of patients with Covid-19
Timepoint
21 days after starting of intervention
Method of measurement
By referring to the patient's medical record
2
Description
The mortality in patients with Covid-19
Timepoint
21 days after starting of intervention
Method of measurement
By referring to the patient's medical record
3
Description
The pulmonary infiltration in patients with Covid-19
Timepoint
7, 14 and 21 days after starting of intervention
Method of measurement
With CT scan
Secondary outcomes
1
Description
Side effects from the use of herbal compounds (COVID-herbs)
Timepoint
7, 14 and 21 days after starting of intervention
Method of measurement
Refer to the medical file and complete a special questionnaire for complications
2
Description
The liver function in patients with Covid-19
Timepoint
7, 14 and 21 days after starting of intervention
Method of measurement
Evaluation of SGOT and SGPT enzymes using ELISA kit
3
Description
The kidney function in patients with Covid-19
Timepoint
7, 14 and 21 days after starting of intervention
Method of measurement
Evaluation of chemical parameters such as BUN and Creatinine by colorimetric method with autoanalyzer
Intervention groups
1
Description
Intervention group: Patients with Covid-19 will consume 10 ml of syrup containing aqueous extracts of Ador-Cancer, saffron petals and mountain tea 3 times a day. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Entry to this study does not require special training. Herbal extract syrup is prepared and approved in Rafsanjan University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: Control group: Yamaran with Covid-19 will take 10 ml of placebo 3 times a day. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Entry to this study does not require special training. The placebo is prepared and approved at Rafsanjan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Patients who have been hospitalized
Full name of responsible person
Ziba Shabani
Street address
Persian Gulf Boulevard
City
rafsanjan
Province
Kerman
Postal code
7718175911
Phone
+98 34 3131 5000
Fax
+98 34 3131 5003
Email
adarehkordi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
ali darekordi
Street address
Persian Gulf Boulevard
City
rafsanjan
Province
Kerman
Postal code
7718175911
Phone
+98 34 3131 5000
Fax
+98 34 3131 5003
Email
adarehkordi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Drehkordi
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
chemistry
Street address
Pistachio Boulevard
City
rafsanjan
Province
Kerman
Postal code
7718175911
Phone
+98 913 290 6232
Fax
+98 34 3131 5003
Email
mojgan.noroozi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
ali darekordi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
chemistry
Street address
Pistachio Boulevard
City
rafsanjan
Province
Kerman
Postal code
7718175911
Phone
+98 34 3131 5000
Fax
+98 34 3131 5003
Email
mojgan.noroozi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
ali darekordi
Position
حقخبثسسخق
Latest degree
Ph.D.
Other areas of specialty/work
chemistry
Street address
Pistachio Boulevard
City
rafsanjan
Province
Kerman
Postal code
7718175911
Phone
+98 34 3131 5000
Fax
+98 34 3131 5000
Email
mojgan.noroozi@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
After the publication of the article, all data will be available to all researchers indefinitely
To whom data/document is available
Everyone
Under which criteria data/document could be used
For research work
From where data/document is obtainable
Refer to the project manager and send an email
Dr. Ali Darreh Kurdi
adarehkordi@yahoo.com
What processes are involved for a request to access data/document
Formal request to the university and then refer to the project manager