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Evaluation of the effect of edible herbal medicine (containing Colchicum autumnale, Olea Europaea, Nigella sativa, Lavandula angustifolia, Zingiber officinale) in decreasing mortality and hospitalization duration in a severe and critical phase of patients with COVID-19.

Protocol summary

Study aim
Determining and comparing the effect of studied herbal medicine in decreasing mortality and hospitalization of patients with COVID-19.
Design
A randomized open-label (without-blinding) clinical trial, with the parallel groups on 150 pateints
Settings and conduct
This randomized open-label clinical trial study was performed on 150 eligible patients with QUID-19, referring to Amin and Al-Zahra hospitals in Isfahan and were randomly divided into 2 groups. The first group receives herbal capsules in addition to the standard treatment and the second group receives only the standard treatment. Then, at the end of the intervention the mortality, and hemodynamic parameters of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the age range of 40-80 years, weighing more than 50 kg, definitive infection with Covid 19, being in the acute and critical phase of the disease, and consent to participate in the study. Exclusion criteria included pregnancy, breastfeeding, the existence of active ulcers in the gastrointestinal tract, taking digoxin, admission to the ward before the start of the study, and a history of allergies to medicinal plants.
Intervention groups
Intervention group: Patients in this group receive standard treatment. In addition, they will be prescribed 2 one-gram oral capsules every 8 hours. The capsules contain 500 mg of honey and 500 mg of oily extract of the studied plant compounds in equal proportions. Control group: Patients in this group will receive only standard treatments.
Main outcome variables
Need for mechanical ventilation; Duration of hospitalization; Need to be admitted to the intensive care unit; death; Number of breaths; heart rate; Interleukin 6; Percentage of oxygen saturation; Lymphocyte level, platelet level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N49
Registration date: 2021-12-25, 1400/10/04
Registration timing: prospective

Last update: 2021-12-25, 1400/10/04
Update count: 0
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of edible herbal medicine (containing Colchicum autumnale, Olea Europaea, Nigella sativa, Lavandula angustifolia, Zingiber officinale) in decreasing mortality and hospitalization duration in a severe and critical phase of patients with COVID-19.
Public title
Evaluation of the effect of edible herbal medicine in decreasing mortality and hospitalization of patients with COVID-19.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 80-40 years Weight over 50 kg Definite infection with COVID-19 according to diagnostic criteria The acute and critical phase of COVID-19 disease who are admitted to the infectious diseases and intensive care unit. Satisfaction to participate in the study
Exclusion criteria:
Pregnancy Breastfeeding Existence of active ulcers in the gastrointestinal tract Patients taking digoxin Patients who have been hospitalized before the start of the study History of allergies to medicinal plants
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
150 eligible patients will be randomly selected. These people are then coded with the help of random allocation computer software and are automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be assigned to a patient and that patient will be randomly studied in one of the two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
IR.MUI.MED.REC.1400.514

Health conditions studied

1

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

Primary outcomes

1

Description
Need for mechanical ventilation
Timepoint
After the intervention
Method of measurement
Observational

2

Description
Duration of hospitalization
Timepoint
After the intervention
Method of measurement
Calculate the number of days

3

Description
Need to be admitted to the intensive care unit
Timepoint
After the intervention
Method of measurement
Observational

4

Description
Mortality
Timepoint
After the intervention
Method of measurement
Observational

Secondary outcomes

1

Description
Number of breaths
Timepoint
Before and after the intervention
Method of measurement
Ventilator device

2

Description
Heart rate
Timepoint
Before and after the intervention
Method of measurement
Ventilator device

3

Description
Percentage of oxygen saturation
Timepoint
Before and after the intervention
Method of measurement
Ventilator device

4

Description
Interleukin 6
Timepoint
Before and after the intervention
Method of measurement
Blood test

5

Description
Lymphocyte level
Timepoint
Before and after the intervention
Method of measurement
Blood test

6

Description
Platelet level
Timepoint
Before and after the intervention
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: Patients in this group receive standard treatment. In addition, they will be prescribed 2 one-gram oral capsules every 8 hours. The capsules contain 500 mg of honey and 500 mg of oily extract of the plant compounds (including containing Colchicum autumnale, Olea Europaea, Nigella sativa, Lavandula angustifolia, Zingiber officinale) in equal proportions.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will receive only standard treatments (including oxygen therapy, antiviral drugs, corticosteroids, anticoagulants and, if necessary, tocilizumab).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Reza Ghadiri
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
drrezaghadiri2@gmail.com

2

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Reza Ghadiri
Street address
Sanbolistan Alley, Ibn Sina Street
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
drrezaghadiri2@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Ghadiri
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Negin Moshtagh Residential Complex, Bustan Street, Sarvestan Street, Jay Shir Blvd.
City
Isfahan
Province
Isfehan
Postal code
832632377
Phone
+98 31 3263 2377
Fax
Email
drrezaghadiri2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Ghadiri
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Negin Moshtagh Residential Complex, Bustan Street, Sarvestan Street, Jay Shir Blvd.
City
Isfahan
Province
Isfehan
Postal code
832632377
Phone
+98 31 3263 2377
Fax
Email
drrezaghadiri2@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Ghadiri
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Negin Moshtagh Residential Complex, Bustan Street, Sarvestan Street, Jay Shir Blvd.
City
Isfahan
Province
Isfehan
Postal code
832632377
Phone
+98 31 3263 2377
Fax
Email
drrezaghadiri2@gmail.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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