Protocol summary
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Study aim
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To evaluate whether traditional medicine combination(the Ferula assa-foetida gum - Tragacanth) increases significant clinical improvement as compared to the standard of treatments in hospitalized patients with moderate to severe COVID-19.
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Design
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This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 122 patients are enrolled and followed for 14 days.
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Settings and conduct
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The study will be conducted in Emam Reza hospital (Mashhad), Radiologists, physicians who assess outcomes and the statistician analyzing the data will be blinded but the patients and physicians who treat patients will know the assigned treatment group.
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Participants/Inclusion and exclusion criteria
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All moderate to severe COVID-19 infected patients admitted to Ema Reza hospital (Mashhad). Inclusion criteria: PCR confirmed; diagnostic chest CT scan.age 18-75y; hospitalization.
Exclusion criteria: Patients with end-stage heart failure; Recent cardiac intervention (less than 2 months): (coronary angioplasty, ICD, CABG, Valvuloplasty or replacement); Pulmonary fibrosis or advanced COPD; End-stage kidney or liver disease; Pregnant or lactating ladies; Patients on immunosuppressive therapy; Active tuberculosis; Active hepatitis, Critical stage of COVID
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Intervention groups
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122eligible patients with moderate to severe COVID-19 in a 1:1 ratio: • Combination of traditional medicine+standard treatment &Control group: standard treatment
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Main outcome variables
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paraclinical recovery within 14 days from initiation of study the change in peripheral blood lymphocyte count (LC) and the different degrees of blood oxygen saturation (PO2)
General information
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Reason for update
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Changes in drug composition and outcomes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200607047675N1
Registration date:
2020-06-15, 1399/03/26
Registration timing:
prospective
Last update:
2022-02-25, 1400/12/06
Update count:
1
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Registration date
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2020-06-15, 1399/03/26
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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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2020-06-19, 1399/03/30
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Expected recruitment end date
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2020-09-05, 1399/06/15
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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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A prospective randomized controlled trial comparing the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth with moderate to severe Coronavirus disease (COVID-19) compared to standard treatment
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Public title
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Evaluation of the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth in Participants with Moderate to Severe Coronavirus 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:
PCR confirmed
diagnostic chest CT scan
Consent for voluntary participation
Hospitalization
Exclusion criteria:
Patients with end stage heart failure
Recent cardiac intervention (less than 2 months): coronary angioplasty, ICD, CABG, Valvuloplasty or replacement
Pulmonary fibrosis or advanced COPD
End stage kidney or liver disease
Pregnant or lactating ladies
Patients on immunosuppressive therapy
Active tuberculosis
Active hepatitis
The critical stage of COID19
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Age
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From 18 years old to 75 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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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
122
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomized in a 1:1 ratio into one of the traditional treatment and standard treatment using the SPSS randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes, and the statistician analyzing the data all will be blinded.
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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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2020-06-06, 1399/03/17
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Ethics committee reference number
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IR.MUMS.REC.1399.285
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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oxygen saturation (≥94% on room air)
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Timepoint
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Day 1 and 14
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Method of measurement
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pulse oximetry
2
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Description
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Lymphocyte count
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Timepoint
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Day 1 and 14
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Method of measurement
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Complete Blood Count
Intervention groups
1
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Description
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Intervention group: 300mg of soft Ferula gum and 150mg of soft tragacanth gum: twice a day, and the national guidelines for the treatment of COVID-19
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Category
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Treatment - Drugs
2
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Description
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Control group: the national guidelines for the treatment of COVID-19
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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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Mashhad 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results.
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When the data will become available and for how long
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At the time of publication
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To whom data/document is available
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Will be publically available as a supplement accompanying the published article.
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Under which criteria data/document could be used
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To interpret the findings of the published study, and to use as a reference for future research
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From where data/document is obtainable
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On the website of the journal that will publish the research
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What processes are involved for a request to access data/document
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They will be publically available.
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Comments
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