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 black myrobalan and mastic and 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 (35 people).
Placebo taking group (35 people)
-
Main outcome variables
-
Chest CT scan findings; Erythrocyte sedimentation rate; C-Reactive Protein; Clinical signs
General information
-
Reason for update
-
Increase sample size
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200415047082N1
Registration date:
2020-04-21, 1399/02/02
Registration timing:
prospective
Last update:
2020-12-02, 1399/09/12
Update count:
1
-
Registration date
-
2020-04-21, 1399/02/02
-
Registrant information
-
-
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:
70
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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: Treatment protocol approved by the Ministry of Health during the period of hospitalization + herbal supplement taking from a combination of black myrobalan and mastic and of sugarcane twice a day without water during the period of hospitalization.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Treatment protocol approved by the Ministry of Health during the period of hospitalization + Placebo taking twice a day Without water during the period of hospitalization.
-
Category
-
Placebo
1
-
Sponsor
-
-
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
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
-