Evaluation of therapeutic effect of Simospan syrup (contains of Thymus vulgaris, Hedera helix, Honey and Vitamin C) on duration of hospitalization in covid-19 patients
Evaluation of the therapeutic effect of Simospan syrup (contains Thymus vulgaris, Hedera helix, Honey, and Vitamin C) on the duration of hospitalization of covid-19 patients
Design
The current study is a clinical trial with a control group, randomized, single-blind on 52 patients (26 patients in each group).
Settings and conduct
Sampling will be done in Vasei hospital. After obtaining conscious consent from qualified patients, first, all of them in terms of the main clinical variable (pulmonary function test) matched and then randomly divided into control and intervention groups. Treatment time is considered 5 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hospitalized patients diagnosed with covid-19; age between 30-60 years; the amount of oxygen saturation below 93%.
Exclusion criteria: pregnancy; lactation; organ damage.
Intervention groups
control group: receive routine treatment based on physician's order.
intervention group: receive routine treatment based on physician's order and receive simospan syrup
Main outcome variables
laboratory parameters, duration of hospitalizations, and the spent time to the improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210621051642N1
Registration date:2021-07-05, 1400/04/14
Registration timing:registered_while_recruiting
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Sajad Seyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1954
Email address
sajadseyedi2004@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-26, 1400/04/05
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Simospan syrup (contains of Thymus vulgaris, Hedera helix, Honey and Vitamin C) on duration of hospitalization in covid-19 patients
Public title
Evaluation of therapeutic effect of Simospan syrup on covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age limitation (30-60 years old)
Hospitalized patients with CT-scan findings in favor of Covid-19 disease
Hospitalized patients with the amount of blood oxygen saturation below 93%
Hospitalized patients with Chest X-ray findings in favor of pneumonia
Hospitalized patients without underlying disease
Exclusion criteria:
Pregnancy and lactation
End-stage Covid-19 patients
Patients diagnosed with underlying disease and organ damage
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 52 samples. The control group(A) does not receive any treatment over common treatment.The 26 numbers of intervention group(B) receives the simospan syrup,. Patients numbers from 000-026 and 027-052 are considered for groups A and B respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Analyzer and data collecting man not be aware of intervention type and participants in control and intervention groups.so the trial will be run as single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Nuclear martyrs boulevard-Above the memorial of the anonymous martyrs-sabzevar university of med-sci pardis
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2021-06-20, 1400/03/30
Ethics committee reference number
IR.MEDSAB.REC.1400.044
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
The spent time to illness improvement
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Variable type is qualitative and its scale is nominal.the criterion of recovery records and descripts based on observations of data collecting man in checklist.relative criterion based on clinical symptoms:1-non-admission along with the return of normal activity-2-non-admission along without the return of normal activity-3-admission without the need for oxygentherapy-4-admission with the need for oxygentherapy-5-admission with the need to receive high speed oxygen from the nose or non invasive ventilation or both-6-admission with the need to receive oxygen therapy with invasive ventilation or oxygen therapy from non pulmonary pathways or both-7- patient's death
2
Description
Discharge from hospital
Timepoint
After the start of intervention
Method of measurement
Duration of hospitalization
Secondary outcomes
1
Description
The blood level of ALT enzyme
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Spectrometer
2
Description
The blood level of BUN
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Spectrometer
3
Description
The blood level of creatinine
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Spectrometer
4
Description
The blood level of AST enzyme
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Spectrometer
5
Description
RBC count
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Cell counter
6
Description
WBC count
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Cell counter
7
Description
The blood level of HG
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Auto analyzer machine
8
Description
The blood level of HCT
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Auto analyzer machine
9
Description
CRP blood test
Timepoint
Before and 5 days after the start of intervention
Method of measurement
ELISA kits
10
Description
ESR test
Timepoint
Before and 5 days after the start of intervention
Method of measurement
Wintrobe method
Intervention groups
1
Description
Control group: routine treatment based on physician's order
Category
Treatment - Other
2
Description
Intervention group: routine treatment based on physician's order and simospan syrup (every 8 hours 6 cc for 5 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Sajad Seyedi
Street address
Nuclear martyrs boulevard-
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4466 5721
Email
sajadseyedi2004@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Vasei Hospital clinical research development center
Street address
Vasei Hospital,Nuclear martyrs Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
CRDC@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Sajad Seyedi
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Heshmatieh hospital, Asadabadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873140
Phone
+98 51 4401 1954
Email
sajadseyedi2004@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sajad Seyedi
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Heshmatie hospital, Asadabadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873140
Phone
+98 51 4401 1954
Email
sajadseyedi2004@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sajad Seyedi
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Heshmatie hospital,Asadabadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873140
Phone
+98 51 4401 1954
Email
sajadseyedi2004@gmail.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
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