Evaluation the effect of Polypodium root preparation on the management of Covid-19 mild to moderate symptoms
Design
A clinical trial with a control group, with parallel groups, single-blinded, randomized, phase 3 will be performed on 40 patients (20 in the intervention group and 20 in the control group) by randomizing the random number table
Settings and conduct
COVID-19 positive rapid test or RT-PCR patients admitted to Ali Asghar Hospital in Shiraz will be divided into two groups of intervention and control. The present study will be double-blind so that patients and physicians will be unaware of how the intervention and control groups assigned.
Participants/Inclusion and exclusion criteria
Patients with COVID-19 positive rapid test or RT-PCR; aged 18 to 70 years with gastrointestinal symptoms
Intervention groups
Intervention group: Iranian standard treatment protocol for COVID-19 in addition to Polypodium oral preparation formulated in Shiraz University of Medical Sciences for 7 days. Control group: the standard treatment protocol of COVID-19 in Iran.
Main outcome variables
clinical symptoms in patients with COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120506009651N4
Registration date:2022-06-07, 1401/03/17
Registration timing:registered_while_recruiting
Last update:2022-06-07, 1401/03/17
Update count:0
Registration date
2022-06-07, 1401/03/17
Registrant information
Name
Maryam Mosaffa-Jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3208 4030
Email address
mosaffam@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-28, 1401/03/07
Expected recruitment end date
2022-11-28, 1401/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of a Polypodium root preparation on the management of Covid-19 mild to moderate symptoms a clinical trial
Public title
Effect of Polypodium in treatment of Coronavirus disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cases who diagnosed as COVID-19 infection by clinical features; laboratory findings (positive C Reactive Protein, Chest X-ray findings, CT scan findings)
clinical/lab confirmation of the disease hospitalization due to COVID-19
Stated willingness to participate in the study and sign a written informed consent document
Exclusion criteria:
Significant allergic reactions to the herbal drug
History of CHF, liver and kidney disorders
Patients with diabetes or other endocrine disorders
People who are constantly monitored and treated with psychiatric drugs
Pregnant/ breast feeding women
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into the treatment and control groups based on simple randomization method and table of random numbers will be used
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher, assessor and data analyst will be blind to the random assignment of patients in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University of Medical Sciences
Street address
7th floor, Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-05-25, 1401/03/04
Ethics committee reference number
IR.SUMS.REC.1401.160
Health conditions studied
1
Description of health condition studied
COVID-19 infection
ICD-10 code
U07.1
ICD-10 code description
Covid-19, confirmed cases, positive test result
Primary outcomes
1
Description
Clinical/lab confirmation of the disease
Timepoint
Weekly after intervention
Method of measurement
Examination- PCR test
2
Description
Hospitalization due to Covid-19
Timepoint
Weekly after intervention
Method of measurement
Hospital report
Secondary outcomes
1
Description
Improvement of COVID-19 symptoms at end of treatment
Timepoint
End of Treatment (7 days after staring intervention)
Method of measurement
General condition of the patient (clinical symptoms)
Intervention groups
1
Description
Intervention group: Polypodium root decoction (4 grams of herbal powder in 250 ml of boiling water), received twice a day for a week and followed up one week after treatment. In terms of response to treatment, which includes the improvement and reduction of clinical symptoms in COVID-19 patients compared to the pre-treatment status of each patient.
Category
Treatment - Drugs
2
Description
For 7 days, no intervention will be performed on patients in the control group except for the usual treatment protocol. Gastrointestinal symptoms are recorded at the beginning of the study and before treatment, and during 7 days, response to treatment, including improvement and reduction of clinical symptoms in COVID-19 patients, is assessed relative to the pre-treatment status in each patient.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Dr. Mehdi Pasalar
Street address
Meshkin Fam Street
City
Shiraz
Province
Fars
Postal code
7143918796
Phone
+98 71 3228 8602
Email
pasalar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Zarshenas
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
PhD in Traditional Pharmacy
Street address
Department of Traditional Pharmact, faculty of Pharmacy, shiraz University of Medical Sciences, Rokn abad street
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4128
Email
zarm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Mosaffa-Jahromi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
PhD in Traditional Pharmacy
Street address
Research Center for Traditional Medicine and History of Medicine, School of Medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
009832084037
Email
mosaffam@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pasalar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Research Center for Traditional Medicine and History of Medicine, School of Medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
009832084029
Email
pasalar@sums.ac.ir
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