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
Evaluation of the effect of Lemon Balm or Star anice in prophylaxis in close contacts and treatment of COVID-19 patients in Bojnurd
Design
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
Settings and conduct
Patients enrolling the clinics in Bojnurd
Participants/Inclusion and exclusion criteria
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
Intervention groups
Lemon Balm capsule
Star Anice capsule
Placebo
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150902023864N2
Registration date:2021-02-08, 1399/11/20
Registration timing:registered_while_recruiting
Last update:2021-02-08, 1399/11/20
Update count:1
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Amir Amani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 218899111824
Email address
aamani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Triple blinded
Blinding description
Capsules and their packaging are similar in terms of their appearance. Only A, B, C have been labelled on them
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
North Khorsan University of Medical Sciences
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Approval date
2020-01-13, 1398/10/23
Ethics committee reference number
IR.NKUMS.REC.1399.093
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Prophylactic study: clinical/lab confirmation of the disease
Timepoint
weekly
Method of measurement
examination- PCR test
2
Description
Prophylactic study: hospitalization due to Covid-19
Timepoint
weekly
Method of measurement
Hospital report
3
Description
Treatment study: general state of patient
Timepoint
weekly
Method of measurement
examination
4
Description
Treatment study: hospitalization due to Covid-19
Timepoint
weekly
Method of measurement
Hospital report
5
Description
Treatment study: death due to Covid-19
Timepoint
weekly
Method of measurement
Hospital report
6
Description
Prophylactic study: death due to Covid-19
Timepoint
weekly
Method of measurement
hospital report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Lemon Balm capsule (Manobrain, Rahman Daroo)- Twice per day
Category
Treatment - Drugs
2
Description
Intervention group 2: Star Anice capsule (Manoflo- Rahman daroo)- Twice per day
Category
Treatment - Drugs
3
Description
Control group: Placebo (starch capsules with same appearance to the intervention groups)- Twice per day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali special clinic
Full name of responsible person
Dr Taghavi
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3221 0940
Email
amani76@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
دکتر محمدرضا تقوی
Street address
Safa
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 7157
Email
amani76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rahman Gostaran
Full name of responsible person
Peyman Akbarian
Street address
Qazvin- Karaj highway, near vahdat gas station
City
قزوین
Province
Qazvin
Postal code
3491872868
Phone
+98 21 2205 8772
Email
info@rahmangostaran.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rahman Gostaran
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Position
acadmic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 90, Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 21 3229 7182
Email
amani76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Position
acadmic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 90, Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 21 3229 7182
Email
amani76@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Position
Acadmic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 90, Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 21 3229 7182
Email
amani76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data potentially may be shared
When the data will become available and for how long
Nearly in a year
To whom data/document is available
All peaple
Under which criteria data/document could be used
there is no condition
From where data/document is obtainable
they can email the PI
What processes are involved for a request to access data/document