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Protocol summary
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris, Lepidium sativum supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris, Lepidium sativum supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
General information
empty
Edited English title.
Edited English title.
empty
اصلاح عنوان انگلیسی
اصلاح عنوان انگلیسی
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris, Lepidium sativum supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris, Lepidium sativum supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris, Lepidium sativum supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of COVID-19
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris, Lepidium sativum supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: پرویز کوخایی
Full name of responsible person - Persian: پرویز کوخایی
Street address - English: Semnan University of Medical Sciences, Basij Blvd, Semnan.
Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی سمنان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514799442
Phone: +98 23 3345 1336
Fax:
Email: P_kokha@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz Kokhaie
Full name of responsible person - Persian: پرویز کوخایی
Street address - English: Semnan University of Medical Sciences, Basij Blvd, Semnan.
Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی سمنان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514799442
Phone: +98 23 3345 1336
Fax:
Email: P_kokha@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: پرویز کوخاییParviz Kokhaie Full name of responsible person - Persian: پرویز کوخایی Street address - English: Semnan University of Medical Sciences, Basij Blvd, Semnan. Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی سمنان City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3514799442 Phone: +98 23 3345 1336 Fax: Email: P_kokha@yahoo.com Web page address:
Protocol summary
Study aim
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Design
Clinical trial with parallel control group, non-randomized, no placebo-controlled, single center trial, Sample size 60 people.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Clinical symptoms (Coronavirus infection).
General information
Reason for update
Edited English title.
Acronym
IRCT registration information
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
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-18, 1398/12/28
Expected recruitment end date
2020-06-16, 1399/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of COVID-19
Public title
Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19)
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.SEMUMS.REC.1398.325
Health conditions studied
1
Description of health condition studied
Coronavirus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Clinical symptoms (Coronavirus infection)
Timepoint
Before starting the study and daily until discharge
Method of measurement
Laboratory values and radiographic changes or CT scans
Secondary outcomes
empty
Intervention groups
1
Description
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).
Category
Treatment - Other
2
Description
Control group: Treatment is according to the protocol and is for comparison only with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Rahimeh Eskandarian
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaie
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rahimeh Eskandarian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rahimeh Eskandarian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rahimeh Eskandarian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available