Protocol summary

Study aim
Surveying the effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19
Design
Clinical trial with control group، Community-based and forward-looking، With parallel groups( Intervention and control)، Two-way blind، Random، One step، Sample size 50 people( 25 persons in each group)، Persons were studied in a simple random method and using a table of random numbers and individually placed in two groups of intervention and control.
Settings and conduct
The study population was patients over 18 years to 65 years with Corona disease. In this study, the improvement of Corona disease symptoms after 10 days is compared with two methods of using herbal tea and common treatment under equal conditions. In this study, an information collection form is used which is evaluated every 24 hours and the resulting scores are compared in both.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients who are clinically proven by PCR and different views on CT scan ( With the confirmation of an infectious disease specialist)--Clinically be in moderate and severe groups- Without organ damage- Age over 18 years- Be in a stable cardiovascular condition. Exit conditions: Patient death during study- Reluctance to continue cooperation- Occurrence of any allergies following the use of plants- Patient treated with chemotherapy or radiotherapy- History of cancer- History of chronic autoimmune diseases- People with seizures and epilepsy- Nervous patients- Pregnancy- breastfeeding End Stage- Individuals with chronic renal failure- Liver failure- Encephalopathy - Neuropathy.
Intervention groups
Intervention group: Using the Hyssop and Verbascum herbal tea three times a day for patients with Covid 19 disease along with commonly used treatments. Control group: Using the common treatments that used in Corona sections.
Main outcome variables
Improving the symptoms of Covide-19 disease.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100130003227N15
Registration date: 2020-12-10, 1399/09/20
Registration timing: prospective

Last update: 2020-12-10, 1399/09/20
Update count: 0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Ashraf Salehi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 5222 7550
Email address
salehi.a@arakmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19.
Public title
The effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are clinically proven by PCR and different views on CT scan ( With the confirmation of an infectious disease specialist). Clinically be in moderate and severe groups. Without organ damage. Age over 18 years. Be in a stable cardiovascular condition.
Exclusion criteria:
Patient death during study Reluctance to continue cooperation Occurrence of any allergies following the use of plants Patient treated with chemotherapy or radiotherapy History of cancer History of chronic autoimmune diseases People with seizures and epilepsy Nervous patients Pregnancy Breastfeeding End Stage People with chronic kidney failure Liver failure Encephalopathy Neuropathy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description: The randomization method is based on gradual references and having the inclusion criteria and interest in participating in the study. Randomization unit: Man Random layers: Material of randomization tool: Random number table How to build a random sequence: Sequence Allocation concealment: The subjects are randomly assigned to two groups (intervention and control) using a table of random numbers. The randomization sequence will be generated based on 4 random permutation blocks using a web-based software (from website: https://www.sealedenvelope.com). The randomization sequence will be provided to the project manager and will be hidden from the person participating in the study and the evaluator's colleague to enter the study until the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study was double-blind. So that the participants and the outcome assessor were unaware of what group the research units were in. Participants were randomly assigned to the intervention and control groups and will not be aware of the type of intervention (Hyssop and Verbascum herbal tea in addition to common drugs for the treatment of Covide 19 or only conventional treatment) before the study start. Assessors, health care personnel (physicians, nurses, etc.) who are responsible for patient care will also not be aware of patient grouping.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees, Khomain University of Medical Sciences
Street address
Quds Boulevard
City
Khomein
Province
Markazi
Postal code
38817-43364
Approval date
2020-10-28, 1399/08/07
Ethics committee reference number
IR.KHOMEIN.REC.1399.012

Health conditions studied

1

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

Primary outcomes

1

Description
Improvement the symptoms of Covide-19disease
Timepoint
Seventh and tenth day
Method of measurement
Intensity of cough- Intensity of shortness of breath- O2 Saturation- Duration of hospitalization in the ward- Respiration Rate- Three-dimensional CT scan changes of the lungs- CBC.diff and ESR and CRP

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": Using the Hyssop (30 grams in 24 hours) and Verbscum (15 grams in 24 hours) herbal tea three times a day (For 7 to 10 days) for patients with Covid 19 disease along with commonly used treatments such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc.
Category
Treatment - Other

2

Description
Control group: Use of common drugs for the treatment of Covid 19 disease such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Khomein city
Full name of responsible person
Mohammad Taheri
Street address
Qods Boulevard
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
rheum.nursing@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khomein Medical University
Full name of responsible person
Dr Mojtaba Didedar
Street address
Qods Blvd
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
rheum.nursing@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein Medical University
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
Khomein School of Medical Sciences
Full name of responsible person
Mohammad Taheri
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qods Boulevard
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
rheum.nursing@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khomein School of Medical Sciences
Full name of responsible person
Ashraf Salehi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qods Boulevard
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
najm54@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khomein School of Medical Sciences
Full name of responsible person
Hamid Moemeni
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qods Boulevard
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
hamid52us@yahoo.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 more 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A large part of the data such as information about the main outcome, how to do, etc. can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
By observing the ethics of research
From where data/document is obtainable
Hamid Moemeni .hamid52us@yahoo.com
What processes are involved for a request to access data/document
Send a request to email and wait for a response, Authentication of the applicant, Send a reply or reply to the applicant after scientific and ethical verification within a maximum of two weeks.
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