Protocol summary
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Study aim
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Determining the effectiveness of basil extract in the treatment of outpatients Covid 19 and also evaluating its effects on reducing mortality or hospitalization due to (SARS-CoV-2)
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Design
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This is a double-blind clinical trial study of phase 2-3. This study will be performed on 140 patients who are divided into two groups. Randomly, one group of outpatients with Covid-19 was given a herbal supplement containing 300 mg of basil extract capsules and one group was given a placebo capsule for 2 weeks with common medications. The blocking method and Randomaize.com randomization site are used for randomization. During this period, patients are followed up for clinical symptoms and severity of the disease and the need for hospitalization.
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Settings and conduct
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This study is performed in 16-hour clinics of Covid-19 in Mashhad. In this study, the physician, patient, and data analyst are unaware of the medication.
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Participants/Inclusion and exclusion criteria
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Outpatients with COVID-19;
Confirmation of RT-PCR test for SARS-CoV-2;
Blood oxygen saturation more than 90%;
Age 18-60 years;
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Intervention groups
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Placebo group: receiving common therapies + herbal medicine placebo (capsule containing microcellulose starch (Avisel) which is similar to the capsule of intervention groups)
Intervention group: receiving common treatments + capsules of 600 mg of basil extract (300 mg twice a day)
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Main outcome variables
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The rate of recovery time from the time of randomization of patients to the improvement of clinical symptoms including fever, cough and myalgia; Paraclinical symptoms including leukopenia and CRP
General information
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Reason for update
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Unfortunately, due to technical problems in making the placebo and sampling, the start of the study was delayed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180103038199N4
Registration date:
2021-04-24, 1400/02/04
Registration timing:
prospective
Last update:
2022-02-08, 1400/11/19
Update count:
1
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Registration date
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2021-04-24, 1400/02/04
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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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2021-12-31, 1400/10/10
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Expected recruitment end date
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2023-01-20, 1401/10/30
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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 complementary therapy with Basil (Ocimum basilicum) capsule on the clinical symptoms of outpatients with COVID-19
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Public title
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Effect of Basil on outpatients with 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:
Outpatients with COVID-19
Confirmed with RT-PCR
SPO2 more than 90%
Age between 18 to 60 years old
Exclusion criteria:
Pregnant women
Breastfeeding women
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Age
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From 18 years old to 60 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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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
140
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The volume of each block will be 4. Then write a list of blocks and assign numbers to them, for example (AABB (1) - BBAA (2) - BABA (3) - BAAB (4)) which according to the sample size of 140 people, we have 35 blocks. Then, random numbers between one and 35 are selected according to the Randomaize.com randomization site, and finally, the treatment allocation list is determined based on random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Due to the use of a placebo similar to interventional therapy, the physician associated with the participants and participants will not be informed of the assigned treatment and also the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-30, 1399/11/11
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Ethics committee reference number
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IR.MUMS.REC.1399.597
Health conditions studied
1
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Description of health condition studied
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COVID-19 disease
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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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Time to recover from illness based on questionnaire
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Timepoint
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before intervention and 3, 7 and 14 days after beginning the intervention
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Method of measurement
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questionnaire
2
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Description
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Normalization of CRP and lymphopenia
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Timepoint
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before the intervention and 14 days after The beginning the intervention
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Method of measurement
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laboratory
Intervention groups
1
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Description
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Control group: Receive common treatments based on the ministry of health protocol + placebo capsules (Avicell) made in Mashhad school of Persian and complementary medicine twice a day for 10 days
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Category
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Placebo
2
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Description
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Intervention group: Receive common treatments based on the ministry of health protocol + capsules containing 300 mg of basil extract made in Mashhad school of Persian and complementary medicine 2 times a day for 10 days
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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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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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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