Protocol summary

Study aim
Reduce the duration of treatment Disease severity phase prevention
Design
Clinical trial with control group, with parallel intervention, double-blind, randomized
Settings and conduct
In Peymaniyeh Hospital of Jahrom, in two groups of intervention and control as follows: Intervention group: Receiver of herbal supplements from a combination of 1000 mg of black myrobalan and 2000 mg of mastic and 3000 mg of sugarcane along with the treatment protocol approved by the Ministry of Health. Control group: Receiver of treatment protocol approved by the Ministry of Health and placebo. The distribution of herbal supplements in the intervention group and placebo in the control group will be done by nurses based on the randomization result announced by the head nurse. The researcher and nurses will not know the randomization results and the type of package that are being given to the patient. The researcher should only provide the necessary supplement for the intervention and provide it to the head nurse.
Participants/Inclusion and exclusion criteria
Study participation criteria: • All patients admitted with a diagnosis of COVID-19 • COVID-19 patients who are willing to participate in study • The patient should not be among high-risk groups, such as breastfeeding or pregnant or etc. • Age> 18 years old • The patient does not have a specific underlying disease. Study exclusion criteria: • Dissatisfaction with continuing with herbal supplements treatment • herbal supplements Intolerance (in case of allergies and other similar cases) • After admission to the ICU • Positive pregnancy test
Intervention groups
Herbal supplement taking group (5 people). Placebo taking group (5 people)
Main outcome variables
Chest CT scan findings; Erythrocyte sedimentation rate; C-Reactive Protein; Clinical signs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200415047082N1
Registration date: 2020-04-21, 1399/02/02
Registration timing: prospective

Last update: 2020-04-21, 1399/02/02
Update count: 0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
esmail rayat dost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5427 7145
Email address
e.rayatdost@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect evaluation of herbal supplementation from the combination of sugarcane, black myrobalan and mastic along with the treatment protocol of the Ministry of Health on the course of COVID-19 disease
Public title
Effect evaluation of herbal supplementation from the combination of sugarcane, black myrobalan and mastic along with the treatment protocol of the Ministry of Health on the course of coronavirus disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients admitted with a diagnosis of COVID-19 COVID-19 patients who are willing to participate in study The patient should not be among high-risk groups, such as breastfeeding or pregnant or etc. Age> 18 years old The patient does not have a specific underlying disease Study
Exclusion criteria:
People who are under 18 years of age People who are among the high-risk group People who have a specific underlying disease People who are characterized as severe in the illness course
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization Randomization unit: individual Randomization tool: from random number table by assigning a code to each patient by the head nurse Allocation concealment: The distribution of herbal supplements in the intervention group and placebo in the control group will be done by nurses based on the randomization result announced by the head nurse. The researcher and nurses will not know the randomization results and the type of package that are being given to the patient. The researcher should only provide the necessary supplement for the intervention and provide it to the head nurse.
Blinding (investigator's opinion)
Double blinded
Blinding description
The distribution of herbal supplements in the intervention group and placebo in the control group will be done by nurses based on the randomization result announced by the head nurse. The researcher and nurses will not know the randomization results and the type of package that are being given to the patient. The researcher should only provide the necessary supplement for the intervention and provide it to the head nurse.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Shahid Motahari Ave.
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.JUMS.REC.1399.003

Health conditions studied

1

Description of health condition studied
New Corona virus disease 2019
ICD-10 code
U07.1
ICD-10 code description
new Corona virus disease 2019

Primary outcomes

1

Description
Symptoms of disease
Timepoint
During the hospital stay, on a daily basis
Method of measurement
The severity of patient's clinical symptoms is measured on the basis of visual analog scale.

2

Description
Vital Signs
Timepoint
During the hospital stay, on a daily basis
Method of measurement
Vital signs monitoring device

3

Description
C-Reactive Protein
Timepoint
During the hospital stay, on a daily basis
Method of measurement
C-Reactive Protein test

Secondary outcomes

1

Description
Pulmonary damages after illness
Timepoint
At the beginning of the study and 14 and 30 days after taking herbal supplements
Method of measurement
Chest Computed Tomography Scan

Intervention groups

1

Description
Intervention group: herbal supplement taking from a combination of 1000 mg of black myrobalan and 2000 mg of mastic and 3000 mg of sugarcane twice a day without water. The duration of herbal supplement taking is one week.
Category
Treatment - Drugs

2

Description
Control group: Placebo taking twice a day Without water. The duration of placebo taking is one week.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Peymanieh hospital
Full name of responsible person
Rahim raufi
Street address
Vali-e-Asr Ave., Peymaniyeh Hospital
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5423 0010
Email
sarahim1513@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavous solhjou
Street address
Jahrom University of Medical Sciences, Shahid Motahari Ave.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
solhjouk@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Alireza hashemi shiri
Position
Extern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Motahari Ave., University of Medical Sciences, Research Unit
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 902 001 0987
Email
Entezar14arh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmail Rayat dost
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Vali-e-Asr Ave., Peymaniyeh Hospital
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5427 7145
Email
e.rayat.dost@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Alireza hashemi shiri
Position
Extern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Motahari Ave., University of Medical Sciences, Research Unit
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 902 001 0987
Fax
Email
Entezar14arh@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
Yes - There is 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
Not applicable
Title and more details about the data/document
All potential data will be shared after people get unrecognizable
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
For public
Under which criteria data/document could be used
Free access
From where data/document is obtainable
for public
What processes are involved for a request to access data/document
by requesting from corresponding writer
Comments
Loading...