Protocol summary
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Study aim
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Evaluation of the effect of Lemon Balm or Star anice in prophylaxis in close contacts and treatment of COVID-19 patients in Bojnurd
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Design
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Shuffle block randomization
Triple blinding
Capsules and their packaging are similar in terms of their appearance. Only A, B, C have been labelled on them
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Settings and conduct
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Patients enrolling the clinics in Bojnurd
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Participants/Inclusion and exclusion criteria
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inclusion criteria
Prophylactic study: Those who live with a Covid-19 patient in a single house. Have not had Covid-19 (or its symptoms) so far. Maximum 7 days have passed since start of Covid-19 symptoms
Treatment study: Covid-19 patients, Maximum 7 days have passed since start of Covid-19 symptoms. Have not taken anti-virus drugs in the last 14 days
exclusion criteria
pregnant/ breast feeding women
Underlying diseases
heprsensitivity to herbal drug used in this study or their derivatives
use of antiviral drugs in the last 2 weeks
use of immune suppressor medicine
use of serotonin inhibitor or othee sedative medicines
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Intervention groups
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Lemon Balm capsule
Star Anice capsule
Placebo
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Main outcome variables
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Prophylactic study:
clinical/lab confirmation of the disease
hospitalization due to COVID-19
death due to COVID-19
Treatment study:
Changes in state of patient
hospitalization due to COVID-19
death due to COVID-19
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:
IRCT20150902023864N2
Registration date:
2021-02-08, 1399/11/20
Registration timing:
registered_while_recruiting
Last update:
2021-03-15, 1399/12/25
Update count:
1
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Registration date
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2021-02-08, 1399/11/20
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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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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-05-22, 1400/03/01
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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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Evaluation of the effect of Lemon Balm/ Star anice in treatment of COVID-19 patients as well as their prophylactic effects in close contacts with COVID-19 patients
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Public title
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Evaluation of the effect of Lemon Balm/ Star anice in treatment of COVID-19 patients as well as their prophylactic effects in close contacts with COVID-19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Prophylactic study: Those who live with a Covid-19 patient in a single house.
Prophylactic study: Have not had Covid-19 (or its symptoms) so far.
Prophylactic study: Maximum 7 days have passed since start of Covid-19 symptoms
Treatment study: Covid-19 patients
Treatment study: Maximum 7 days have passed since start of Covid-19 symptoms.
Treatment study: Have not taken anti-virus drugs in the last 14 days
Exclusion criteria:
pregnant/ breast feeding women
Underlying diseases
heprsensitivity to herbal drug used in this study or their derivatives
use of antiviral drugs in the last 2 weeks
use of immune suppressor medicine
use of serotonin inhibitor or othee sedative medicines
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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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3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Shuffle block randomization
To conceal the data, the medicines will have same packaging and will have a single code. So that the prescriber and the researcher will not know about the medicine.
Sampling will be based on shuffle block randomization. For instance the block 1 has been given below.. In sample 1 of the block one we have 1, 3, 1, group a, PP1. This shows that in block 1, having block size of 3, we give group 1 to the first sample with code PP1
Group A: treatment A, Group B: treatment B, Group C: Treatment C
Block sizes: 3
block identifier, block size, sequence within block, treatment code
• 1, 3, 1, group a, PP1
• 1, 3, 2, group b, CT2
• 1, 3, 3, group c, WV6
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Capsules and their packaging are similar in terms of their appearance. Only A, B, C have been labelled on them
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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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2020-01-13, 1398/10/23
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Ethics committee reference number
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IR.NKUMS.REC.1399.093
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, virus identified
Primary outcomes
1
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Description
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Prophylactic study: clinical/lab confirmation of the disease
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Timepoint
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weekly
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Method of measurement
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examination- PCR test
2
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Description
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Prophylactic study: hospitalization due to Covid-19
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Timepoint
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weekly
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Method of measurement
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Hospital report
3
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Description
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Treatment study: general state of patient
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Timepoint
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weekly
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Method of measurement
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examination
4
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Description
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Treatment study: hospitalization due to Covid-19
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Timepoint
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weekly
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Method of measurement
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Hospital report
5
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Description
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Treatment study: death due to Covid-19
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Timepoint
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weekly
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Method of measurement
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Hospital report
6
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Description
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Prophylactic study: death due to Covid-19
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Timepoint
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weekly
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Method of measurement
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hospital report
Intervention groups
1
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Description
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Intervention group 1: Lemon Balm capsule (Manobrain, Rahman Daroo)- Twice per day
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Star Anice capsule (Manoflo- Rahman daroo)- Twice per day
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo (starch capsules with same appearance to the intervention groups)- Twice per day
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Category
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Placebo
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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Rahman Gostaran
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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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Private
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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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Industry
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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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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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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All data potentially may be shared
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When the data will become available and for how long
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Nearly in a year
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To whom data/document is available
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All peaple
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Under which criteria data/document could be used
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there is no condition
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From where data/document is obtainable
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they can email the PI
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What processes are involved for a request to access data/document
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We do our best to deliver the data in a month
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Comments
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