Protocol summary

Study aim
The effect of Rosa Damascena extract in treatment of COVID-19 patients in kosar hospital, Semnan
Design
Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 20 people.
Settings and conduct
In this study we will enroll 10 patients with COVID-19 who will be consequently admitted to semnan hospital. The patients will receive 5 cc of rose water in spite of drugs suggested by Iranian Health ministry management guidelines and patients in the control group will receive water. all the patients will be followed for one week and the mortality rate, the number of recovered or discharged patients and the need for ICU admission in control and intervention group will compare.
Participants/Inclusion and exclusion criteria
Patients with COVID-19 who are older than 18 years old
Intervention groups
Intervention group: To 10 patients with COVID-19 who are admitted to kosar hospital. In addition to the usual protocols of the Ministry of Health, patients will be given 5 cc of rose water (Factory Construction Barij Essence) in a glass of water every 8 hours for a week. Control group: Patients are treated according to national protocol and received water.
Main outcome variables
The mortality rate, the recovered or discharged rate, ICU admission

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200402046917N1
Registration date: 2020-08-31, 1399/06/10
Registration timing: registered_while_recruiting

Last update: 2020-08-31, 1399/06/10
Update count: 0
Registration date
2020-08-31, 1399/06/10
Registrant information
Name
maliheh Ghadir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3665 3309
Email address
ghadirm12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosa Damascena extract in treatment of COVID-19 patients in kosar hospital, Semnan
Public title
therapeutic effect of Rosa Damascena extract in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with COVID-19 according to history, physical examو radiological findings and PCR test of naso pharynx and oro pharynx
Exclusion criteria:
patients who need invasive positive pressure ventilation or ICU care during 24h from their admission
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
A double-blind study is performed and patients and health care providers and patient recovery assessors as well as primary data analyzers do not know who is in the control group and who is in the main group and the recipient of the extract.
Placebo
Used
Assignment
Parallel
Other design features
ِduring the study the clinical status, the improvement of patients' condition, the need for ICU care, and mortality will be evaluated according to a questionnaire.

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
2020-07-05, 1399/04/15
Ethics committee reference number
IR.SEMUMS.REC.1399.106

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.01
ICD-10 code description
Covid-19 infection

Primary outcomes

1

Description
Mortality rate
Timepoint
After 7 days
Method of measurement
Questionnaire, Patient data and physician

2

Description
Recovery or discharge rate
Timepoint
After 7 days
Method of measurement
Questionnaire, Patient data and physician

3

Description
ICU admission
Timepoint
After 7 days
Method of measurement
Questionnaire, Patient data and physician

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: To 10 patients with COVID-19 who are admitted to kosar hospital. In addition to the usual protocols of the Ministry of Health, patients will be given 5 cc of rose water (Factory Construction Barij Essence) in a glass of water every 8 hours for a week.
Category
Treatment - Other

2

Description
Control group: Patients are treated according to national protocol and receive water.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Maliheh Ghadir
Street address
semnan, Basij highway
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0021
Email
ghadirm12@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Malihe ghadir
Street address
semnan basij highway
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0021
Email
alizadehbio@gmail.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
Karaj University of Medical Sciences
Full name of responsible person
Maliheh Ghadir
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
endocrinology
Street address
No 65, 12ed West Vahdat Avenue, Vahdat Town, Karaj, Alborz Province, Iran
City
Karaj
Province
Alborz
Postal code
3165867774
Phone
+98 26 3665 3309
Email
ghadirm12@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Maliheh Ghadir
Position
consultant
Latest degree
Subspecialist
Other areas of specialty/work
endocrinology
Street address
No. 65, 12ed west Ave., Vahdat Town, Karaj, Alborz province, Iran
City
Karaj
Province
Alborz
Postal code
3165867774
Phone
+98 26 3665 3309
Email
ghadirm12@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Akram alizadeh
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue engineering
Street address
Semnan basij highway
City
semnan
Province
Semnan
Postal code
3165867774
Phone
+98 23 3344 0021
Fax
Email
alizadehbio@gmail.com

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
No - There is not 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
filled patients' questionnaires
When the data will become available and for how long
after publication
To whom data/document is available
all of the researchers
Under which criteria data/document could be used
they will be available just for clearance and approval of the results
From where data/document is obtainable
Maliheh Ghadir
What processes are involved for a request to access data/document
It will take one week after receiving the email
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