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The effect of Heilichrysum pseudoplicatum-syrupe on clinical manifestations and Para clinical features in patients with COVID-19: A Randomized clinical trial.

Protocol summary

Study aim
The effect of H.pseudoplicatum-syrup on clinical presentation and respiratory infection of patients with COVID-19
Design
This study is a clinical trial. In this study, there are two groups which consist of the experimental group (receive H.pseudoplicatum-syrup) and the control group (receive the routine treatment). The number of people in each group is 30. This is a single blind study, which statistical analyzers do not know about data and drugs.
Settings and conduct
The study site is in the Arak University of Medical Sciences. First of all, fatigue, anorexia, oxygen saturation, and blood pressure of patients will be measured. If they have the conditions of study, they will randomly divide into two groups. One group receives H.pseudoplicatum-syrup and the other group receives routine treatment. This study is a single blind study which statistical analyzers do not have knowledge about groups. At the end of the 2-week intervention phase, fatigue, anorexia, oxygen saturation and blood pressure in these patients will be measured again and the effectiveness of H.pseudoplicatum-syrup will be compared with the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: "Having informed consent to participate in the study, definitive diagnosis of COVID-19 and not attending in another clinical trial." exclusion criteria include: "Patient willingness to accept other therapies
Intervention groups
Drug group: Syrup based on the H.pseudoplicatum, which is produced with a concentration of 10% aqueous extract of H.pseudoplicatum, is prescribed for 2 weeks 3 times a day, 5 ml each time, a total of 15 ml daily. This syrup is made by Traditional and Complementary Medicine Research Center of Arak University of Medical Sciences. Control group: takes routine drugs.
Main outcome variables
Fatigue, anorexia, oxygen saturation and blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180610040049N6
Registration date: 2020-12-04, 1399/09/14
Registration timing: retrospective

Last update: 2020-12-04, 1399/09/14
Update count: 0
Registration date
2020-12-04, 1399/09/14
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
2020-05-18, 1399/02/29
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Heilichrysum pseudoplicatum-syrupe on clinical manifestations and Para clinical features in patients with COVID-19: A Randomized clinical trial.
Public title
The effect of Heilichrysum pseudoplicatum-syrupe 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
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a simple randomized clinical trial on patients with COVID-19. In this study, simple randomization method will be used. A randomized list will be generated by online randomization site (sealedenvelope.com). Individuals will be allocated to intervention or control group according to the list.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drug group is given Heilichrysum pseudoplicatum-syrupe and the control group receives their routine medications. The statistical analyst is not informed about the groups.
Placebo
Not 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
2020-04-14, 1399/01/26
Ethics committee reference number
IR.ARAKMU.REC.1399.003

Health conditions studied

1

Description of health condition studied
Patients with Corona Virus
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Fatigue
Timepoint
One day before the intervention and 2 weeks after the intervention is measured
Method of measurement
Using a fatigue questionnaire

2

Description
Anorexia
Timepoint
One day before the intervention and 2 weeks after the intervention is measured
Method of measurement
Using anorexia questionnaire

3

Description
Oxygen saturation
Timepoint
One day before the intervention and 2 weeks after the intervention is measured
Method of measurement
Using a pulse oximeter

4

Description
blood pressure
Timepoint
One day before the intervention and 2 weeks after the intervention is measured
Method of measurement
Using a sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" This group consumes the Heilichrysum pseudoplicatum-syrupe. The concentration of this syrup is 10% of the aqueous extract of Heilichrysum pseudoplicatum-syrupe. This syrup is administered three times daily for two weeks, 5 ml each time, a total of 15 ml daily. This syrup is made by Shahid Beheshti School of Pharmacy and Traditional and Complementary Medicine Research Center of Arak University of Medical Sciences.
Category
Treatment - Drugs

2

Description
Control group: This group only receives their routine drugs.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Valiasr Hospital
Full name of responsible person
Hosein Sarmadian
Street address
Valiasr Hospital, Imam St, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
hosseinsarmadian2015@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, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Hosein Sarmadian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
hosseinsarmadian2015@yahoo.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
Shahid Beheshti School of Pharmacy, Valiasr St, Tehran
City
Tehran
Province
Tehran
Postal code
6153- 14155
Phone
+98 21 8820 0118
Email
mkamalinejad@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, Arak
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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