Protocol summary
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Study aim
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Assessment of the effect of Iranian medicine product, Nigle 7 capsule and black seed mixture , on the symptoms of patients with covid-19 (Coronavirus 19 disease)
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Design
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This clinical trial has control group, and with parallel groups, One-way blind, randomized, phase 2 to 3 and is performed on 80 patients. Randomization method will be blocked randomization (Quaternary random blocks).
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Settings and conduct
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Patients in the drug group take the Iranian traditional drug for ten days (three capsules a day and ten grams of black seed mixture daily). Patient in control group use routine treatment (According to the protocol of the Ministry of Health). The study is performed in Baqiyatallah Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Male or female patients 18 years old and older with COVID-19, Ground glass view at low-dose CT scan, Consciously completed consent form completed by the patient or the patient's supervisor. Exclusion criteria: History of pulmonary malignancy, History of asthma or COPD, History of Disabling disease or malignancy, Liver or kidney disorders.
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Intervention groups
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Intervention groups will be two ones.Patients in the intervention group will receive the intervention drug in addition to the routine treatment, but in control group, they will receive routine treatment.
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Main outcome variables
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3D lung CT Scans, dyspnea, cough, CBC diff
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160131026298N6
Registration date:
2020-09-08, 1399/06/18
Registration timing:
prospective
Last update:
2020-11-01, 1399/08/11
Update count:
2
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Registration date
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2020-09-08, 1399/06/18
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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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2020-11-05, 1399/08/15
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Expected recruitment end date
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2021-03-20, 1399/12/30
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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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Evaluation of the effectiveness of Nigel-7 capsule and black seed mixture on COVID-19
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Public title
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Evaluation of the effectiveness of Nigel-7 capsule and black seed mixture on corona
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male or female patients 18 years old and older with Coronavirus Disease 2019 (COVID-19)
Ground glass view at low-dose CT scan
Consciously completed consent form completed by the patient or the patient's supervisor
Exclusion criteria:
History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method will be blocked randomization (Blocks of size 4). Randomization units are individuals. Eighty outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups according to form of random string produced by online random allocation .
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2020-03-29, 1399/01/10
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Ethics committee reference number
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IR.BMSU.REC.1399.157
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.2
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ICD-10 code description
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U07.2 COVID-19, virus not identified, COVID-19
Primary outcomes
1
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Description
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Measurement of cough severity
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Timepoint
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Day 1 before and at the end of treatment
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Method of measurement
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Cough scoring form
2
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Description
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Severity of shortness of breath
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Timepoint
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Day 1 before and at the end of treatment
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Method of measurement
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Shortness Of Breath With Daily Activity (SOBDA) Questionnaire
3
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Description
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Lung radiologic changes
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Timepoint
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At beginning and end of the study
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Method of measurement
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Chest CT scan
Intervention groups
1
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Description
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Intervention group: Intervention groups will be two ones. Patients in the intervention group will receive the intervention drug (three capsules a day and ten grams of black seed mixture daily) that is made by Talaye sabze tooba company; in addition to the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) .
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group will receive the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) .
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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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Yes
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Title of funding source
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Bagheiat-allah 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available