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Evaluation of the therapeutic effect of thyme essence in corona patients

Protocol summary

Study aim
The therapeutic effect of thyme essential oil in patients with new corona virus infection
Design
The clinical trial has a control group and a parallel intervention group, blinded, randomized to 100 patients. For randomization, the table of random numbers based on online software (Kit Set) has been used.
Settings and conduct
In this study, patients will be selected from 18-50 year olds whose corona tests were positive and hospitalized in Valiasr Hospital, Zanjan, Iran. The number of people studied in each group is 50. This study includes two groups: Control group: Patients with covid19 who do not receive any other drug (thyme essential oil) except the drug protocol. Intervention group: Patients with covid 19 who, in addition to medication, receive thyme essential oil according to the protocol. It is prepared as a syrup (made from the essence of 10% of thyme). Each patient takes three doses a day, 5 cc each, for one week. Evaluation of results and effectiveness after taking the drug (thyme syrup), fever, cough, runny nose, shortness of breath, headache, muscle aches, sore throat, anorexia, fatigue, weakness and lethargy.
Participants/Inclusion and exclusion criteria
Entry criteria: COVID 19 Patients 50-18 years of age in the rehabilitation center. Exclusion criteria: respiratory diseases; pregnant women; allergic diseases and dissatisfaction with participation in the study.
Intervention groups
Intervention Group 1: In addition to receiving medication based on the treatment protocol, 15 cc of syrup containing 10% thyme essential oil is given daily in three divided doses for one week. Intervention Group 2: They only receive medication based on the treatment protocol.
Main outcome variables
Thyme may be able to speed up the healing of fever, cough, runny nose, shortness of breath, headache, muscle aches, sore throat, anorexia, fatigue, weakness and lethargy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200506047319N1
Registration date: 2020-05-22, 1399/03/02
Registration timing: prospective

Last update: 2020-05-22, 1399/03/02
Update count: 0
Registration date
2020-05-22, 1399/03/02
Registrant information
Name
Narjes Khavasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6141
Email address
nxavasi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-30, 1399/03/10
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of thyme essence in corona patients
Public title
Evaluation of the effect of thyme on corona patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People infected by new corona virus Age over 18 years and under 50 years Patients with covid virus 19 hospitalized in Valiasr Hospital
Exclusion criteria:
Respiratory diseases Pregnant woman Allergic diseases Dissatisfaction with participating in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Assign patients to two groups of intervention and control using the table of online random numbers (kit set)
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
Zanjan University of Medical Sciences Ethics Committee
Street address
Vice Chancellor for Research and Technology, Zanjan University of Medical Sciences,Third floor, second building, Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
047‏IR.ZUMS.REC.1399

Health conditions studied

1

Description of health condition studied
New Corona virus infection
ICD-10 code
J00-J99
ICD-10 code description
بیماری‌های دستگاه تنفسی

Primary outcomes

1

Description
Cough
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Fever
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

2

Description
Runny nose
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

3

Description
Shortness of breath
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

4

Description
Headache
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

5

Description
Muscle pain
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

6

Description
Sore throat
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

7

Description
Anorexia
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

8

Description
Weakness and lethargy
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

9

Description
Percentage of people who are tired
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Multi-Dimensional Fatigue Questionnaire of Asmets (MFI)

Intervention groups

1

Description
Intervention group: In addition to receiving medication based on hospital protocol, patients receive 15 cc of daily syrup containing 10% thyme essence in three divided doses. The syrup was prepared by Gol Daru Company on the order of the University of Medical Sciences.
Category
Treatment - Drugs

2

Description
Control group: The only treatment based on hospital protocol is similar to the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Narjes Khavasi
Street address
Valiasr Hospital, above Valiasr Square, Sheikh Fazlollah Nouri Highway
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Fax
+98 24 3377 0751
Email
valiasr@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Vice Chancellor for Research and Technology, third floor, second building, Zanjan University of Medical Sciences, Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6393
Fax
+98 24 3342 4770
Email
research@zums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Narjes Khavasi
Position
Assistant Professor, Specialist Physician. science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vice Chancellor for Research and Technology, Third floor, Second building, Zanjan University of Medical Sciences, Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6393
Email
nxavasi@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Narjes Khavasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vice Chancellor for Research and Technology, Third floor, Second building, Zanjan University of Medical Sciences, Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6393
Email
nxavasi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Narjes Khavasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vice Chancellor for Research and Technology, Third floor, Second building, Zanjan University of Medical Sciences, Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4525613191
Phone
+98 24 3315 6393
Email
nxavasi@zums.ac.ir

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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be summarized in the form of tables and diagrams in the form of an article
When the data will become available and for how long
At the end of the study, access will begin at most 6 months after the article is published.
To whom data/document is available
The documents will be provided to researchers working at Zanjan University of Medical Sciences and research committees as needed.
Under which criteria data/document could be used
Documents will only be available for limited research.
From where data/document is obtainable
To the Vice Chancellor for Research and Technology of Zanjan University of Medical Sciences
What processes are involved for a request to access data/document
Considering that he is the material and spiritual owner of Zanjan University of Medical Sciences. Written consent must be obtained from the University of Medical Sciences and the Vice Chancellor for Research and Technology.
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