Protocol summary
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Study aim
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Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
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Design
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Clinical trial with parallel control group, non-randomized, no placebo-controlled, single center trial, Sample size 60 people.
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Settings and conduct
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In addition to the treatment protocol, patients are given four daily doses of 300 mg of Vulgaris.C supplemented with Herbal tea (2g Pennyroyal; 2g chamomile, 1.4g Hollyhocks and 0.6g Mallow).
Semnan Kowsar Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: COVID-19 Patients Admitted to Kowsar Hospital Respiratory Ward.
Exclusion criteria: Malignant diseases (Cancers); Severe renal, liver and heart failure; Taking anticoagulants especially warfarin; Pregnancy; Lactating mothers.
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Intervention groups
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Intervention group: In addition to the treatment protocol, patients are given four daily doses of 300 mg of Vulgaris.C supplemented with Herbal tea (2g Pennyroyal; 2g chamomile, 1.4g Hollyhocks and 0.6g Mallow).
Control group: Treatment is according to the protocol and is for comparison only with the intervention group.
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Main outcome variables
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Clinical symptoms (Coronavirus infection).
General information
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Reason for update
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Edited English title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151228025732N51
Registration date:
2020-04-08, 1399/01/20
Registration timing:
registered_while_recruiting
Last update:
2020-09-26, 1399/07/05
Update count:
1
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Registration date
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2020-04-08, 1399/01/20
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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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2020-03-18, 1398/12/28
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Expected recruitment end date
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2020-06-16, 1399/03/27
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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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Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of COVID-19
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Public title
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Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (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:
COVID-19 Patients Admitted to Kowsar Hospital Respiratory Ward
Exclusion criteria:
Malignant diseases (Cancers)
Severe renal, liver and heart failure
Taking anticoagulants especially warfarin
Pregnancy
Lactating mothers
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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:
60
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Randomization (investigator's opinion)
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Not randomized
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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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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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2020-03-18, 1398/12/28
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Ethics committee reference number
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IR.SEMUMS.REC.1398.325
Health conditions studied
1
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Description of health condition studied
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Coronavirus
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ICD-10 code
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B34.2
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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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Clinical symptoms (Coronavirus infection)
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Timepoint
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Before starting the study and daily until discharge
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Method of measurement
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Laboratory values and radiographic changes or CT scans
Intervention groups
1
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Description
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Intervention group: In addition to the treatment protocol, patients are given four daily doses of 300 mg of Vulgaris.C supplemented with Herbal tea (2g Pennyroyal; 2g chamomile, 1.4g Hollyhocks and 0.6g Mallow).
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Category
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Treatment - Other
2
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Description
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Control group: Treatment is according to the protocol and is for comparison only with the intervention group.
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Category
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Diagnosis
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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Semnan 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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No - There is not a plan to make this available
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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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available