Protocol summary
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Study aim
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Evaluation and presentation of an uncomplicated herbal medicine and a simple and limited treatment in controlling and reducing the outward and vital signs of patients with coronavirus.
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Design
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1. A placebo group that uses common medicines and boiled water.
2. A group of patients who use only common medications.
3. A group of patients who use common medications with the extract of the plant under study
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Settings and conduct
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Ali Asghar hospital; Strong clinical diagnosis of patients based on lung scan sciatica. This procedure is quick and easy, with a 98% chance of success, however, it is still a definitive test with RT PCR testing. Therefore, both factors will be evaluated for the final diagnosis and confirmation of the disease. CBC, CRP, ESR, blood pressure, heart rate and blood oxygen concentration will also be assessed and recorded for patients.
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Participants/Inclusion and exclusion criteria
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Positive corona testing or confirmation of symptoms such as fever, muscle and bone pain, cough and sore throat. In a paraclinical study, platelet counts, white blood cell counts, and ESR and CRP levels were significantly increased. In the blood gas test, the saturation of O2 is less than 93%. In contrast, patients with a history of allergies to herbal remedies or those with liver, kidney, heart, and vascular insufficiency will be excluded from the study. Patients with diabetes or other endocrine diseases, as well as people who are constantly under the control and treatment of neuroleptic drugs, are not included in the study. Normally, pregnant and lactating mothers will not be included in the study due to the lack of sufficient evidence on the safety of herbal medicine. Patients who are unable to swallow or have NPO are removed and patients are mechanically ventilated.
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Intervention groups
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2 groups of drugs and control
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Main outcome variables
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Low production costs, low side effects
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:
IRCT20200508047345N1
Registration date:
2020-06-14, 1399/03/25
Registration timing:
prospective
Last update:
2022-01-25, 1400/11/05
Update count:
1
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Registration date
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2020-06-14, 1399/03/25
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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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2020-06-21, 1399/04/01
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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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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 Effectiveness of Combined Extract of 8 Medicinal Plants on the Control of Mild to Moderate Symptoms of Covid-19 Disease: A Clinical Trial
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Public title
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Combined effects of Extracts on 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:
Positive corona testing or confirmation of symptoms such as fever, muscle and bone pain, cough and sore throat
In the paraclinical study of these patients, platelet counts, white blood cell counts, as well as ESR and CRP levels were significantly increased
In the blood gas test, the saturation of O2 is less than 93%
Exclusion criteria:
Patients who have a history of allergies to herbal medicines or have insufficiency and underlying liver, kidney, heart and vascular diseases
Patients with diabetes or other endocrine diseases
Normally, pregnant and lactating mothers also have insufficient evidence of the safety of herbal medicine due to the lack of evidence
Patients who are unable to swallow or are NPO
Patients under mechanical ventilation
People who are constantly under the control and treatment of neuroleptic drugs
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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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:
100
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Randomization (investigator's opinion)
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N/A
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Randomization description
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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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Other
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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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2020-05-05, 1399/02/16
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Ethics committee reference number
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IR.SUMS.REC.1399.179
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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Percentage of people with normal breathing (oxygen saturation value)
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Timepoint
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Measurement of oxigenesis at the beginning of the study and 1, 2, 3, 4 and 5 days after starting to use the medicinal extract
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Method of measurement
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Pulse Oximeter instrument
Intervention groups
1
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Description
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Control group: Uses common medicines and boiled water
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Due to the fact that the resulting extract is prepared at a temperature of less than 100. C (70) C) and is in fact a kind of drink, the amount of consumption of the rules of consumption of the drink is followed by a slight change in consumption time. Typically, herbal teas are prescribed 3 times a day and 100 cc each time. In this study, people with the disease are prescribed 5 cc of the extract at intervals of 30 minutes. The total amount of extracted in 24 hours for each patient is 240 cc.
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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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Shiraz 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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There is no further information
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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