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The effect of Trachyspermum copticum-based traditional medicine product on clinical manifestations and Para clinical features in patients with COVID-19: A Randomized clinical trial

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History
# Registration date Revision Id
2 2020-04-05, 1399/01/17 128177
1 2020-03-29, 1399/01/10 127206
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  • General information

    2018-04-09, 1397/01/20
    2020-04-08, 1399/01/20
    2018-05-10, 1397/02/20
    2020-05-09, 1399/02/20
    empty
    The reason for the update is the modification of the drug manufacturer.
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    علت بروزرسانی اصلاح سازنده دارو می باشد.

  • Intervention groups

    #1
    "Intervention group:" This group consumes the Trachyspermum copticum syrup. The Trachyspermum copticum plant is a member of the Umbrella family. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Trachyspermum copticum. This syrup is administered three times daily for two weeks, 5 ml each time, a total of 15 ml daily. The syrup is made by Barij Essence and Shahid Beheshti Pharmaceutical Group.
    "Intervention group:" This group consumes the Trachyspermum copticum syrup. The Trachyspermum copticum plant is a member of the Umbrella family. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Trachyspermum copticum. This syrup is administered three times daily for two weeks, 5 ml each time, a total of 15 ml daily. The syrup is made by Shahid Beheshti School of Pharmacy.
    "گروه مداخله:" این گروه شربت گیاهی زنیان مصرف می کنند. گیاه زنیان از خانواده گیاه چتریان است. عصاره توتال این گیاه استفاده می شود. غلظت این شربت 10 درصد از عصاره ابی زنیان می باشد. به مدت دو هفته به صورت سه بار در روز هر بار 5 میلی لیتر جمعا 15 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 زنیان مصرف می کنند. گیاه زنیان از خانواده گیاه چتریان است. عصاره توتال این گیاه استفاده می شود. غلظت این شربت 10 درصد از عصاره ابی زنیان می باشد. به مدت دو هفته به صورت سه بار در روز هر بار 5 میلی لیتر جمعا 15 میلی لیتر روزانه تجویز می‌شود. این شربت توسط دانشکده 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.
    "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.

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arak University of Medical Sciences
    Full name of responsible person - Persian: دانشگاه علوم پزشکی اراک
    Street address - English: Arak University of Medical Sciences, Basij Square
    Street address - Persian: میدان بسیج، دانشگاه علوم پزشکی اراک
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3645
    Fax:
    Email: seiedalatifi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Kamali
    Full name of responsible person - Persian: علیرضا کمالی
    Street address - English: Arak University of Medical Sciences, Basij Square
    Street address - Persian: میدان بسیج، دانشگاه علوم پزشکی اراک
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3645
    Fax:
    Email: seiedalatifi@yahoo.com
    Web page address:

Protocol summary

Study aim
The effect of Trachyspermum copticum 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 Trachyspermum copticum 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 Valiasr Hospital in Arak. 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 Trachyspermum copticum 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: IRCT20180610040049N3
Registration date: 2020-03-29, 1399/01/10
Registration timing: prospective

Last update: 2020-04-05, 1399/01/17
Update count: 1
Registration date
2020-03-29, 1399/01/10
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
2020-04-08, 1399/01/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Trachyspermum copticum-based traditional medicine product on clinical manifestations and Para clinical features in patients with COVID-19: A Randomized clinical trial
Public title
The effect of Trachyspermum copticum 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
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.ARAKMU.REC.1398.342

Health conditions studied

1

Description of health condition studied
Patients with Corona Virus
ICD-10 code
U07.1
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

2

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

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" This group consumes the Trachyspermum copticum syrup. The Trachyspermum copticum plant is a member of the Umbrella family. The total extract of this plant is used.The concentration of this syrup is 10% of the aqueous extract of Trachyspermum copticum. This syrup is administered three times daily for two weeks, 5 ml each time, a total of 15 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
Arak Valiasr Hospital.
Full name of responsible person
Seied Amirhosein Latifi
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
seiedalatifi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
seiedalatifi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
seiedalatifi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
seiedalatifi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
seiedalatifi@yahoo.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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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