Protocol summary
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Study aim
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Determination The Eeffect of a Persian Natural Medicine Product based on Tahini Oil on Clinical Signs in Suspected Patients with COVID-19
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Design
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Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 1 on 100 patients. SNOSE is used for randomization.
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Settings and conduct
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Patients referring to Ghaem Specialized Clinic in Mashhad, in two groups of intervention and control, in addition to treatment according to protocol, medicine and placebo, which is called 1 and 2; The front and back of the chest will be rubbed; clinical signs will be checked and recorded by phone on days 0, 7, and 14. Participants, clinical caregivers, outcome assessors, data analyzers, and blinders.
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Participants/Inclusion and exclusion criteria
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Patients referred to a specialist center diagnosed with suspected coronavirus infection; criteria for non-entry: pregnant and lactating mothers.
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Intervention groups
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ntervention group; treatment based on the latest national protocol with the use of a combination product of sesame flour and in the control group; treatment based on the latest national protocol and drug use that is packaged in similar cans, will be done
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Main outcome variables
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Fever, chills, olfactory weakness, loss of taste, shortness of breath, fatigue, weakness and myalgia, dyspnea, headache, hospitalization, death of patients
General information
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Reason for update
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Date of beginning and end of patients' visits and relocation of patients
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Acronym
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covid-19
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IRCT registration information
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IRCT registration number:
IRCT20140407017169N2
Registration date:
2020-04-28, 1399/02/09
Registration timing:
prospective
Last update:
2021-02-02, 1399/11/14
Update count:
1
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Registration date
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2020-04-28, 1399/02/09
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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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2020-04-30, 1399/02/11
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Expected recruitment end date
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2020-06-21, 1399/04/01
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Actual recruitment start date
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2020-05-08, 1399/02/19
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Actual recruitment end date
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2020-08-16, 1399/05/26
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Trial completion date
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2020-08-30, 1399/06/09
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Scientific title
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The Effect of a Persian Natural Medicine Product based on Tahini Oil on Clinical Signs in Suspected Patients with COVID-19
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Public title
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Effect of natural from Tahini oil product 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:
Patients referred to a specialist center diagnosed by a suspected infectious disease specialist in Corona
Have at least three symptoms of fever / chills, clear chest or voice / shortness of breath, cough / sore throat, general weakness / muscle pain, and have a positive CRP blood test and leukopenia.
Exclusion criteria:
. Pregnant and lactating mothers
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Age
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From 15 years old
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Gender
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Both
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Phase
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0
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To create a simple random sequence, two-group web-based randomization (www.graphpad.com) will be used, and to hide the random allocation, the closed-sequence envelope method with random sequence (SNOSE) will be used. An accident is recorded on a card and the cards are placed inside the named cleaners in order. In order to maintain random randomness, the numbering on the external surface is done in the same way. Finally, the lids of the letter envelopes are pasted and placed inside the boxes, respectively. At the beginning of the registration of the participants, according to the order of the participants and the conditions of the study, one of them is a special test book or letter.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Participant
Care provider
Outcome assessor
Data Analyzer
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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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100 patients referred to Sidi Special Clinics and Ghaem Hospital of Mashhad University of Medical Sciences, which 1) according to the diagnosis of a suspected infectious disease specialist, are considered to have 19 outpatient treatment indications and 3) have the criteria to enter the study method. The available sampling will be selected to provide sample size. Accidental allocation of patients to two groups of 50 interventions (treatment based on the latest national protocol dated April 4, 2017 (chloroquine, naproxen and azithromycin) with the use of a combination product of sesame flour and cow butter, which is basically combined and controlled (treatment based on the latest national protocol And the use of pharmaceuticals that will be prescribed in similar cans with the product of the Special Intervention Group of the Control Group. To create a simple random sequence of web-based randomization (www.graphpad.com), two-group and to hide the random allocation, closed envelope method Will be used with random sequencing (SNOSE). Execution of random allocation process by a person other than the team The study will show that patients in both intervention and control groups, in addition to treatment according to the protocol, will apply the ointment and placebo five times a day for four hours in the amount of one tablespoon of jam (2 g) of the combined product on the back and chest. Prescribing medication and medication is blinded by a specialist
Ethics committees
1
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Ethics committee
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Approval date
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2020-04-13, 1399/01/25
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Ethics committee reference number
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IR.GMU.REC.1399.014
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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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Fever
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Timepoint
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At the beginning of the study (before the start of the intervention) and 7 and 14 days after the start of intervention.
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Method of measurement
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check list
2
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Description
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chills
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Timepoint
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At the beginning of the study (before the start of the intervention) and 7 and 14 days after the start of intervention.
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Method of measurement
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check list
3
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Description
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Respiratory rate
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Timepoint
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At the beginning of the study (before the start of the intervention) and 7 and 14 days after the start of intervention.
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Method of measurement
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check list
4
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Description
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Inpatient period
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Timepoint
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At the beginning of the study (before the intervention) and 7 and 14 days after the intervention
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Method of measurement
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check list
5
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Description
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Death of patients
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Timepoint
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At the beginning of the study (before the intervention) and 7 and 14 days after the intervention
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Method of measurement
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check list
Intervention groups
1
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Description
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Patients in the two intervention and control groups, in addition to treatment according to the protocol, will rub the ointment and placebo 2 and 1 times five times a day for four hours in the amount of one tablespoon of jam (2 g) of the combined product on the back and chest.
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Category
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Treatment - Drugs
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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Social Development and Health Promotion Research Center
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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