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Evaluating efficacy and safety of Stopcivir (Zataria multiflora Boiss+ Alium Sativum+ Heracleum persicum+ Satureja hortensis+ Dianthus+ Foeniculum vulgare+ opium) syrup on length of hospitalization in patients with COVID-19

Protocol summary

Study aim
The aim of this study was to investgate the effectiveness of Stop civir syrup consisting of Zataria multiflora Boiss, Alium Sativum, Heracleum persicum, Satureja hortensis, Dianthus, Foeniculum vulgare and a small amount of opium in patients with COVID-19.
Design
This study is a clinical trial with a control group, with parallel, double-blind, randomized, phase 3 groups on 150 patients. The Rand function of the Excel software was used for randomization.
Settings and conduct
This study will be performed in Imam Khomeini Hospital in Amol city and Firoozgar Hospital in Tehran. Patients are randomly assigned to be divided into two groups, treatment and non-treatment, according to the randomization block table (using software). To blind the study, the drugs are packaged in special envelopes with double-digit codes so that only the final evaluator, who is a physician, is aware of the type of medication that patients are receiving. Also, in order not to inform the patient, the placebo is given to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The definitive case of covid 19 based on laboratory confirmation the probable diagnosis of covid 19 based on respiratory symptoms with radiological manifestations. Patients between 18-75 years Exclusion criteria: The presence of comorbidities Pregnancy and lactation History of allergies to herbal drugs Crisis and severe cases
Intervention groups
Treatment with Stopcivir: 75 patients will treat with the Stopcivir syrup for the first two days is10 cc every 4 hours and the next two days is 10 cc every 6 hours, with standard medications. Placebo: 75 patients will receive placebo for the first two days is10 cc every 4 hours and the next two days is 10 cc every 6 hours, with standard medications.
Main outcome variables
Length of hospitalization Shortness of breath Oxygen saturation

General information

Reason for update
Acronym
Stopcivir syrup
IRCT registration information
IRCT registration number: IRCT20200411047016N1
Registration date: 2020-05-31, 1399/03/11
Registration timing: registered_while_recruiting

Last update: 2020-05-31, 1399/03/11
Update count: 0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Motahareh Rouhi Ardeshiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 1064
Email address
m.roohi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-05, 1399/01/17
Expected recruitment end date
2020-06-06, 1399/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating efficacy and safety of Stopcivir (Zataria multiflora Boiss+ Alium Sativum+ Heracleum persicum+ Satureja hortensis+ Dianthus+ Foeniculum vulgare+ opium) syrup on length of hospitalization in patients with COVID-19
Public title
The effect of Stopcivir syrup in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive case of covid 19 based on laboratory confirmation Diagnosis of covid 19 based on CT or chest radiography Patients between 18-75 years
Exclusion criteria:
The presence of comorbidities (sever renal failure, sever liver failure, CHF, major cerebrovascular and cardiovascular disease, chronic lung disease, malignancy, immune system diseases including AIDS, encephalopathy) Pregnancy and lactation History of allergies to herbal drugs Crisis and severe cases
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be by blocking randomization (quadruple random blocks). Which is provided by statistical software. Randomization units are individuals. 150 outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups. This study is a two-course method and patients in the intervention group will receive the intervention drug in addition to the routine treatment, but in the patient control group, they will receive the placebo along with the routine treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, the drugs are packaged with special tags with double-digit codes so that only the final evaluator, who is a physician, is aware of the type of medication that patients are receiving. Also, in order not to inform the patient, the placebo is given to the control group. Therefore, patients are not aware of the type of medication they are receiving.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.MAZUMS.REC.1399.061

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
Length of hospitalization
Timepoint
Hospitalization time and Hospital discharge time
Method of measurement
Check List

2

Description
Shortness of breath
Timepoint
Variable will be completed in the form of a checklist at the beginning of the Hospitalization and daily until the end of hospitalization.
Method of measurement
Check list

3

Description
Oxygen saturation
Timepoint
Variable will be completed in the form of a checklist at the beginning of the Hospitalization and daily until the end of hospitalization.
Method of measurement
Check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, the content of specific ratios of garlic, Lamiaceae, Heracleum persicum, Dianthus, Satureja hortensis plus a little opium in an alcohol-based solvent will be prepared and used as an adjunctive or concomitant medication alongside other routine medicine to treat patients with covid 19. Both groups will receive standard treatment. The dosage of the syrup for the first two days is 10 cc every 4 hours and the next two days is 10 cc every 6 hours, which is given to the patient by the ward nurse and is monitored.
Category
Treatment - Drugs

2

Description
Control group: The other group receives the placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Amol city
Full name of responsible person
Seyde Sedighe Yousefi
Street address
Center for Traditional Medicine and Complementary Medicine of Mazandaran University; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Email
s.yousefi@mazums.ac.ir

2

Recruitment center
Name of recruitment center
Firoozgar Hospital Tehran
Full name of responsible person
Seyde Sedighe Yousefi
Street address
Center for Traditional Medicine and Complementary Medicine of Mazandaran University; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Email
s.yousefi@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3325 7230
Email
m.saeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Sedigheh Yousefi
Position
Assistent Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Touba Clinic; Khazar Boulevard; Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3324 4893
Fax
+98 11 3324 4893
Email
s.yousefi@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyde Sedighe Yousefi
Position
Assistent Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Touba Clinic; Khazar Boulevard; Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3324 4893
Fax
+98 11 3324 4893
Email
s.yousefi@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Motahareh Rouhi Ardeshiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Peyambar Azam Complex, Farah Abad Blvd., Sari town, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4816968688
Phone
+98 11 3310 1064
Email
m.roohi@mazums.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
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