Explanation of Havay-e-Vabaie based on Iranian medicine and relation of it with epidemies. Determining the effect of the Iranian Medicine Product based on Mentha longifolia (nasal spray) on clinical and para clinical conditions of patients with COVID-19: clinical trial
Determining the effect of Mentha longifolia spray on clinical and paraclinical status of patients with COVID-19
Design
This study is a phase 1 and 2 clinical trial, randomized, and also has a control group which has been done on 60 patients. Study is not blind. The random allocation process will be done with Random allocation software.
Settings and conduct
This study is performed in Razi Hospital of Ghaemshahr city. Infection of these patients has been confirmed by an infectious disease specialist based on clinical signs and changes in lung CT scan or standard corona test (PCR).
After selecting the samples with inclusion criteria, the samples will be assigned to two groups of intervention and control, using blocking. The random allocation process will be done with Random allocation software. This study is non blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who in addition to acute respiratory disease (ARI) have one or more of the following symptoms:
RR> 30.
PO2 <93%.
Pulmonary infiltration in chest x ray.
Clinical judgment of specialist physician.
2. Age range of (18-75) years of both sexes.
Exclusion criteria:
1. Pregnancy and breastfeeding
2. Existence of any history of allergy to Mentha longifolia and its products
3. Inability of the patient to consume the oral form
4. The existence of any condition which prevents the patient from continuing the therapeutic intervention based on the physician's judgment
Intervention groups
Patients will be divided into two groups: intervention and control.
The control group will receive the routine treatment but the intervention group would also receive Mentha longifolia spray beside the routine treatment.
Explanation of Havay-e-Vabaie based on Iranian medicine and relation of it with epidemies. Determining the effect of the Iranian Medicine Product based on Mentha longifolia (nasal spray) on clinical and para clinical conditions of patients with COVID-19: clinical trial
Public title
The effect of Mentha longifolia spray on patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who, have one / more of the following symptoms, in addition to acute respiratory illness (ARI):•RR> 30•PO2 <93% •Pulmonary infiltration in chest x-ray •Clinical judgment of a specialist physician
2- Age range of (18-75) years of both sexes
3- patient must not have any serious simultaneous heart, lung, brain and endocrine diseases
4- The patient's ability and personal desire to fill out a personal consent form to enter the study
Exclusion criteria:
Pregnancy and breastfeeding
Existence of any history of allergy to Mentha longifolia and its products
patient's Inability to consume the oral form
existence of any condition that prevents the continuing of the therapeutic intervention based on the physician's judgment
Patient intubation
Nausea and vomiting
Resistant hypoxemia
loss of consciousness
Hemodynamic instability
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples with inclusion criteria, the samples will be assigned to two groups using blocking. The random allocation process will be done with Randm allocation software. For this purpose, 10 blocks will be determined with this software and the block size is six. Based on this list, these samples are assigned to each of the intervention or control groups, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Hazrat Vali Asr Highway
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.MAZUMS.REC.1399.7483
2
Ethics committee
Name of ethics committee
National Research Ethics Committee.
Street address
Qods Town
City
Tehran
Province
Tehran
Postal code
4815733971
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.MAZUMS.REC.1400.680
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Diseases of the respiratory system
Primary outcomes
1
Description
Reduction of hospitalization rate
Timepoint
Daily
Method of measurement
Patient record
2
Description
Respiratory rate
Timepoint
Daily
Method of measurement
By RR monitor or manual counting of breaths
3
Description
Oxygen saturation
Timepoint
8 am and 8 pm
Method of measurement
Pulsoximeter
Secondary outcomes
1
Description
heart rate
Timepoint
twice a day
Method of measurement
By monitor or manually
2
Description
Blood pressure measurement
Timepoint
Daily
Method of measurement
Mercury sphygmomanometer
Intervention groups
1
Description
Intervention group: included patients who have been admitted to the corona sections of Razi Hospital in Ghaemshahr with a definitive diagnosis of Covid 19. They are also eligible for inclusion in the study based on inclusion criteria. After the needed explanations by the assistant of Persian medicine or infectious disease physician assistant about the study and obtaining written consent, they enter the study and their information is recorded. In addition to routine medications, this group is also treated with Mentha longifolia spray. This spray is prepared in the Faculty of Pharmacy of Shahid Beheshti University. The product is made using a carbol with a concentration of 1.5% as a dilute gel with a pH: 6 to prevent mucosal damage. This group receives 2 puffs in each nostril, 15 minutes before breakfast and dinner, for 2 weeks in maximum. Before use, the drug must be examined and controlled in terms of microbial contamination . The prepared spray will be examined in terms of sterility in the microbiological laboratory of Shahid Beheshti School of Pharmacy.
Category
Treatment - Drugs
2
Description
Control group: includes patients who have been admitted to the corona sections of Razi Hospital in Ghaemshahr with a definitive diagnosis of Covid 19. They are also eligible for inclusion in the study based on inclusion criteria. After the needed explanations by the assistant of Persian medicine or infectious disease physician assistant about the study and obtaining written consent, they enter the study and their information is recorded. This group only receives routine medications. No intervention is made for this group. Only the necessary information will be recorded.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital of Ghaemshahr city
Full name of responsible person
Yousofpour Mohammad
Street address
Yousef Reza Street
City
Ghaemshahr city
Province
Mazandaran
Postal code
1142218021
Phone
+98 11 4221 8018
Fax
+98 11 4221 8019
Email
razi-ghh@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
pajoheshi@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Yousofpour Mohammad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Hazrat Vali Asr Highway
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4426
Email
m.yousefpour@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Babam Mahmoodi Culture
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Yousef Reza Street
City
Ghaemshahr city
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 4221 8018
Email
farhang.baba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yousofpour Mohammad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Hazrat Vali Asr Highway
City
Sari city
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4426
Email
m.yousefpour@mazums.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
The items that can be shared are:
The rate of reduction of patients' hospitalization
Their clinical condition
Their laboratory status
Other related data
When the data will become available and for how long
The access period will be started 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions and industrialist can send request to receive data.
Under which criteria data/document could be used
Applicants must obtain written permission from the owners of the documents if they intend to use the documents commercially.
From where data/document is obtainable
Dr. Mohammad Yousofpour
Mazandaran University of Medical Sciences
Postal Code: 4815733971
Phone: 00981133044426
Fax: 00981133044426
Email: m.yousofpoor@yahoo.com
What processes are involved for a request to access data/document
Sending a written request through the institution or the factory manager to the email of the first project executor
Sending the necessary identification documents
Checking in documents
signing a memorandum of agreement
Providing the required documentations to the applicant