Protocol summary
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Study aim
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The effect of Trachyspermum copticum syrup on clinical presentation and respiratory infection of patients with COVID-19
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Design
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This is a clinical trial. In this study, there are two groups of control ( who receive placebo ) and the intervention group (receiving Trachyspermum copticum syrup). The number of people in each group is thirty. The study is triple blind: participants, therapeutic staff, and statistical analyst of data and drugs are blinded.
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Settings and conduct
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This study is carried out in Valiasr Hospital in Arak. This study is conducted by a researcher and a medical staff in a triple blind manner.
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Participants/Inclusion and exclusion criteria
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Patients with COVID-19, written and informed satisfaction of patients
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Intervention groups
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Patients with COVID-19 who have the criteria for entering the study are randomly divided into two groups then,Then for 2 weeks the patients in the intervention group will receive the Trachyspermum copticum syrup and the control group will receive placebo.
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Main outcome variables
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Respiratory infection
General information
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Reason for update
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The reason for the update is the modification of the drug manufacturer.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180610040049N3
Registration date:
2020-03-29, 1399/01/10
Registration timing:
prospective
Last update:
2020-04-05, 1399/01/17
Update count:
1
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Registration date
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2020-03-29, 1399/01/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-08, 1399/01/20
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Expected recruitment end date
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2020-05-09, 1399/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Trachyspermum copticum-based traditional medicine product on clinical manifestations and Para clinical features in patients with COVID-19: A Randomized clinical trial
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Public title
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The effect of Trachyspermum copticum syrup on clinical manifestations of patients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having informed consent to participate in the study
The definitive diagnosis of COVID-19
Failure to attend another clinical trial simultaneously
Exclusion criteria:
Patient's willingness to use other therapies
Alzheimer's patients
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Age
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From 20 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The block randomization method with 4, 6 and 8 block sizes will be used to assign people to the two groups. Concealment will also be observed by using this method. In this way, each individual is assigned a unique code and is attached to drug packages that will help the blind process.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this three-blind study , patient and therapeutic personnel and data analyst do not have any type of data and medications. The drugs are encoded and placed on the patient and medical personnel.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.ARAKMU.REC.1398.342
Health conditions studied
1
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Description of health condition studied
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Patients with Corona Virus
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ICD-10 code
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U07.1
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Level of CRP in serum
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Timepoint
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One day before the intervention and one day after the intervention is measured
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Method of measurement
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Using the ELISA technique
2
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Description
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The rate of lung inflammation
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Timepoint
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One day before the intervention and one day after the intervention is measured
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Method of measurement
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CT SCAN
Intervention groups
1
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Description
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"Intervention group:" This group consumes the Trachyspermum copticum syrup. The Trachyspermum copticum plant is a member of the Umbrella family. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Trachyspermum copticum. This syrup is administered three times daily for two weeks, 5 ml each time, a total of 15 ml daily. The syrup is made by Shahid Beheshti School of Pharmacy.
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Category
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Treatment - Drugs
2
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Description
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"Control group:" This group is taking placebo. Placebo syrup have the same size and shape as the drug.The placebo syrup contains all the basic ingredients of a syrup without the addition of herbal medicine. The placebo syrup is made by Shahid Beheshti School of Pharmacy.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable