The comparison of effectiveness of Tanacetum parthenium (L) Sch. syrups on clinical and paraclinical features of inpatients infected with 2019 novel coronavirus COVID-19, Parallel randomized trial
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General information
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The reason for the update is the modification of the drug manufacturer.
The reason for the update is the modification of the drug manufacturer.
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علت بروزرسانی اصلاح سازنده دارو می باشد.
علت بروزرسانی اصلاح سازنده دارو می باشد.
Intervention groups
#1
"Intervention group:" This group consumes the Trachyspermum copticum syrup. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Tanacetum parthenium (L) Sch. This syrup is administered three times daily for two weeks, 7 ml each time, a total of 21 ml daily. The syrup is made by Barij Essence and Shahid Beheshti Pharmaceutical Group.
"Intervention group:" This group consumes the Trachyspermum copticum syrup. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Tanacetum parthenium (L) Sch. This syrup is administered three times daily for two weeks, 7 ml each time, a total of 21 ml daily. The syrup is made by Shahid Beheshti School of Pharmacy
"Intervention group:" This group consumes the Trachyspermum copticum syrup. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Tanacetum parthenium (L) Sch. This syrup is administered three times daily for two weeks, 7 ml each time, a total of 21 ml daily. The syrup is made by Barij Essence and Shahid Beheshti Pharmaceutical Group.School of Pharmacy
"گروه مداخله:" این گروه شربت گیاهی اقحوان مصرف می کنند. غلظت این شربت 10 درصد از عصاره ابی اقحوان می باشد. به مدت دو هفته به صورت سه بار در روز هر بار 7 میلی لیتر جمعا 21 میلی لیتر روزانه تجویز می‌شود. این شربت توسط شرکت باریج اسانس و گروه داروسازی شهید بهشتی ساخته می شود.
"گروه مداخله:" این گروه شربت گیاهی اقحوان مصرف می کنند. غلظت این شربت 10 درصد از عصاره ابی اقحوان می باشد. به مدت دو هفته به صورت سه بار در روز هر بار 7 میلی لیتر جمعا 21 میلی لیتر روزانه تجویز می‌شود. این شربت توسط دانشکده داروسازی شهید بهشتی ساخته می شود.
"گروه مداخله:" این گروه شربت گیاهی اقحوان مصرف می کنند. غلظت این شربت 10 درصد از عصاره ابی اقحوان می باشد. به مدت دو هفته به صورت سه بار در روز هر بار 7 میلی لیتر جمعا 21 میلی لیتر روزانه تجویز می‌شود. این شربت توسط شرکت باریج اسانس و گروهدانشکده داروسازی شهید بهشتی ساخته می شود.
#2
"Control group:" This group is taking placebo. Placebo syrup have the same size and shape as the drug.The placebo syrup contains all the basic ingredients of a syrup without the addition of herbal medicine. The placebo syrup is made by Barij Essence and Shahid Beheshti Pharmaceutical Group.:
"Control group:" This group is taking placebo. Placebo syrup have the same size and shape as the drug.The placebo syrup contains all the basic ingredients of a syrup without the addition of herbal medicine. The placebo syrup is made by Shahid Beheshti School of Pharmacy
"Control group:" This group is taking placebo. Placebo syrup have the same size and shape as the drug.The placebo syrup contains all the basic ingredients of a syrup without the addition of herbal medicine. The placebo syrup is made by Barij Essence and Shahid Beheshti Pharmaceutical Group.:School of Pharmacy
"گروه کنترل:" این گروه دارونما مصرف می کنند. شربت پلاسبو دارای اندازه و شکل یکسان با دارو هستند. شربت پلاسبو حاوی تمام ترکیبات پایه یک شربت بدون افزودن داروی گیاهی می باشد.توسط شرکت باریچ اسانس و گروه داروسازی شهید بهشتی ساخته می شود.
"گروه کنترل:" این گروه دارونما مصرف می کنند. شربت پلاسبو دارای اندازه و شکل یکسان با دارو هستند. شربت پلاسبو حاوی تمام ترکیبات پایه یک شربت بدون افزودن داروی گیاهی می باشد.توسط دانشکده داروسازی شهید بهشتی ساخته می شود.
"گروه کنترل:" این گروه دارونما مصرف می کنند. شربت پلاسبو دارای اندازه و شکل یکسان با دارو هستند. شربت پلاسبو حاوی تمام ترکیبات پایه یک شربت بدون افزودن داروی گیاهی می باشد.توسط شرکت باریچ اسانس و گروهدانشکده داروسازی شهید بهشتی ساخته می شود.
Protocol summary
Study aim
The effect of Tanacetum parthenium (L) Sch syrup on clinical presentation and respiratory infection of patients with COVID-19
Design
This is a clinical trial. In this study, there are two groups of control ( who receive placebo ) and the intervention group (receiving Tanacetum parthenium (L) syrup). The number of people in each group is thirty. The study is triple blind: participants, therapeutic staff, and statistical analyst of data and drugs are blinded.
Settings and conduct
This study is carried out in Forghani Hospital in Qom. This study is conducted by a researcher and a medical staff in a triple blind manner.
Participants/Inclusion and exclusion criteria
Patients with COVID-19, written and informed satisfaction of patients
Intervention groups
Patients with COVID-19 who have the criteria for entering the study are randomly divided into two groups then,Then for 2 weeks the patients in the intervention group will receive the Tanacetum parthenium (L) Sch syrup and the control group will receive placebo.
Main outcome variables
Respiratory infection
General information
Reason for update
The reason for the update is the modification of the drug manufacturer.
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040049N4
Registration date:2020-04-03, 1399/01/15
Registration timing:prospective
Last update:2020-04-10, 1399/01/22
Update count:1
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Amirhosein Latifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3601
Email address
Sah.latifi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-05-08, 1399/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of Tanacetum parthenium (L) Sch. syrups on clinical and paraclinical features of inpatients infected with 2019 novel coronavirus COVID-19, Parallel randomized trial
Public title
The effect of Tanacetum parthenium (L) Sch syrup on clinical manifestations of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
The definitive diagnosis of COVID-19
Failure to attend another clinical trial simultaneously
Exclusion criteria:
Patient's willingness to use other therapies
Alzheimer's patients
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method with 4, 6 and 8 block sizes will be used to assign people to the two groups. Concealment will also be observed by using this method. In this way, each individual is assigned a unique code and is attached to drug packages that will help the blind process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this three-blind study , patient and therapeutic personnel and data analyst do not have any type of data and medications. The drugs are encoded and placed on the patient and medical personnel.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Shahid Lavasani Street,Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.MUQ.REC.1399.012
Health conditions studied
1
Description of health condition studied
Patients with Corona Virus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Level of CRP in serum
Timepoint
One day before the intervention and one day after the intervention is measured
Method of measurement
Using the ELISA technique
Secondary outcomes
1
Description
The rate of lung inflammation
Timepoint
One day before the intervention and one day after the intervention is measured
Method of measurement
CT SCAN
Intervention groups
1
Description
"Intervention group:" This group consumes the Trachyspermum copticum syrup. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Tanacetum parthenium (L) Sch. This syrup is administered three times daily for two weeks, 7 ml each time, a total of 21 ml daily. The syrup is made by Shahid Beheshti School of Pharmacy
Category
Treatment - Drugs
2
Description
"Control group:" This group is taking placebo. Placebo syrup have the same size and shape as the drug.The placebo syrup contains all the basic ingredients of a syrup without the addition of herbal medicine. The placebo syrup is made by Shahid Beheshti School of Pharmacy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferghani Hospital
Full name of responsible person
Mohsen Bahrami
Street address
Shahid Lavasani Street,Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 38 4817 6341
Email
bahramiazam26@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
Shahid Lavasani Street,Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3417 3645
Email
research@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Reza Shirvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Lavasani Street,Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
bahramiazam26@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad KamaliNejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Valiasr Ave., Down the Nayayesh intersection, Shahid Beheshti School of Pharmacy
City
Qom
Province
Ghoum
Postal code
6153- 14155
Phone
+98 21 8820 0118
Email
mkamalinejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohsen Bahrami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Lavasani Street,Qom University of Medical Sciences
City
Qum
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
bahramiazam26@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD