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The effect of herbal tea (including mallow flower, chicory seeds, sweet violet flower, Melilotus officinalis and Bindii) on improving respiratory symptoms in patients with Covid-19

Protocol summary

Study aim
Determining the effect of herbal tea (including mallow flower, chicory seeds, sweet violet flower, Melilotus officinalis and Bindii) on improving respiratory symptoms in patients with Covid-19
Design
A clinical trial, with the parallel groups, no blinding, randomized
Settings and conduct
This not blind, randomized clinical trial will be performed at shafa hospital. This study will be performed on 40 patients with Covid-19 in two groups. One group is treated with hydroxychloroquine. The other group will receive herbal tea in addition to hydroxychloroquine treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive result of PCR or CT scan for COVID-19 disease in accordance with international standards Age 60-15 years Patient consent to participate in the study exclusion criteria: Has diseases such as Alzheimer's, Parkinson's, multiple sclerosis, neuromuscular diseases, myasthenia gravis Pregnant women Patients with blood pressure lower than 40/90 mmHg Breathe more or equal to 30 per minute Blood oxygen saturation less than 93% at rest PaO2 to FiO2 ratio less than or equal to 300 mmHg Patients with more than 50% of exudative lesions in 24-48 hours in the lung image
Intervention groups
Control group: Patients in this group will receive only the routine treatment. Intervention group: Patients in this group, in addition to receiving routine treatment, will use the herbal tea including mallow flower, chicory seeds, sweet violet flower, Melilotus officinalis and Bindii. In this way, a jam spoon (equivalent to 5 grams of powdered this herbal composition) with a cup of boiling water (equivalent to 150 cc) is brewed for 25-30 minutes and after straining it is given to the patient. This herbal tea will be prescribed half an hour after lunch for 5 days.
Main outcome variables
Early signs; Clinical manifestations; Patient outcome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200806048318N1
Registration date: 2020-08-20, 1399/05/30
Registration timing: prospective

Last update: 2020-08-20, 1399/05/30
Update count: 0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Zohreh Vakili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3331 2755
Email address
z.vakili@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of herbal tea (including mallow flower, chicory seeds, sweet violet flower, Melilotus officinalis and Bindii) on improving respiratory symptoms in patients with Covid-19
Public title
The effect of herbal tea on improving respiratory symptoms in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive result of PCR or CT SCAN of COVID-19 disease in accordance with international standards Age 60-15 years Patient consent to participate in the study
Exclusion criteria:
Has diseases such as Alzheimer's, Parkinson's, multiple sclerosis, neuromuscular diseases, myasthenia gravis Pregnant women Patients with blood pressure lower than 40/90 mmHg Breathe more or equal to 30 per minute Blood oxygen saturation less than 93% at rest PaO2 to FiO2 ratio less than or equal to 300 mmHg Patients with more than 50% of exudative lesions in 24-48 hours in the lung image
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups of 40 using the random block method with 2 blocks. So that the first two cases are separated and assigned to group one, the second two cases are separated and assigned to group two, and this will be continued two by two in the same way till the ending of samples.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-02, 1399/05/12
Ethics committee reference number
IR.MUI.MED.REC.1399.359

Health conditions studied

1

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19 disease

Primary outcomes

1

Description
Respiratory rate
Timepoint
Before the intervention and the first to fifth days of treatment
Method of measurement
Observation

2

Description
Number of coughs
Timepoint
Before the intervention and the first to fifth days of treatment
Method of measurement
Observation

3

Description
Percentage of oxygen saturation
Timepoint
Before the intervention and the first to fifth days of treatment
Method of measurement
Pulse Oximeter device

4

Description
Shortness of breath
Timepoint
Before the intervention and the first to fifth days of treatment
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group, in addition to receiving routine treatment, will use the herbal tea including mallow flower, chicory seeds, sweet violet flower, Melilotus Officinalis, and Bindii. In this way, a jam spoon (equivalent to 5 grams of powdered this herbal composition) with a cup of boiling water (equivalent to 150 cc) is brewed for 25-30 minutes and after straining it is given to the patient. This herbal tea will be prescribed half an hour after lunch for 5 days.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will be received only routine treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mehdi Akhve
Street address
Shafa Specialized Hospital (Kalishad and Sudarjan), Baharestan, Kalishad, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8456168452
Phone
+98 31 3748 9392
Fax
Email
--@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
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
Mehdi Akhveh
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 7, First Floor, No. 26, Residence Apartment, Sub-12, West Alley, Telecommunication Street, Shahinshahr.
City
Isfahan
Province
Isfehan
Postal code
8314678409
Phone
+98 31 3312755
Email
arnica.darou@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Akhveh
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 7, First Floor, No. 26, Residence Apartment, Sub-12, West Alley, Telecommunication Street, Shahinshahr.
City
Isfahan
Province
Isfehan
Postal code
8314678409
Phone
+98 31 3312755
Email
arnica.darou@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Akhveh
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 7, First Floor, No. 26, Residence Apartment, Sub-12, West Alley, Telecommunication Street, Shahinshahr.
City
Isfahan
Province
Isfehan
Postal code
8314678409
Phone
+98 31 3312755
Email
arnica.darou@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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