History
# Registration date Revision Id
2 2020-11-28, 1399/09/08 161299
1 2020-04-21, 1399/02/02 130591
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  • Protocol summary

    In Peymaniyeh Hospital of Jahrom, in two groups of intervention and control as follows: Intervention group: Receiver of herbal supplements from a combination of 1000 mg of black myrobalan and 2000 mg of mastic and 3000 mg of 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.
    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.
    در بیمارستان پیمانیه جهرم، در دو گروه مداخله و کنترل بدین شکل: گروه مداخله: دریافت کننده مکمل گیاهی حاصل از ترکیب 1000 میلی گرم هلیله سیاه و 2000 میلی گرم مصطکی و 3000 میلی گرم شکر سرخ در کنار پروتکل درمانی مورد تایید وزارت بهداشت گروه کنترل: دریافت پروتکل درمانی مورد تایید وزارت بهداشت و دارونما توزیع مکمل گیاهی به گروه مداخله و دارونما به گروه کنترل توسط پرستاران بخش بر اساس نتیجه تصادفی سازی که توسط سرپرستار اعلام می شود، صورت میگیرد. محقق و پرستاران از نتایج تصادفی سازی و نوع بسته ای که به بیمار تحویل می دهند اطلاع نخواهند داشت. محقق تنها باید مکمل لازم برای انجام مداخله را تامین و به سرپرستار ارائه دهد.
    در بیمارستان پیمانیه جهرم، در دو گروه مداخله و کنترل بدین شکل: گروه مداخله: دریافت کننده مکمل گیاهی حاصل از ترکیب هلیله سیاه و مصطکی و شکر سرخ در کنار پروتکل درمانی مورد تایید وزارت بهداشت گروه کنترل: دریافت پروتکل درمانی مورد تایید وزارت بهداشت و دارونما توزیع مکمل گیاهی به گروه مداخله و دارونما به گروه کنترل توسط پرستاران بخش بر اساس نتیجه تصادفی سازی که توسط سرپرستار اعلام می شود، صورت میگیرد. محقق و پرستاران از نتایج تصادفی سازی و نوع بسته ای که به بیمار تحویل می دهند اطلاع نخواهند داشت. محقق تنها باید مکمل لازم برای انجام مداخله را تامین و به سرپرستار ارائه دهد.
    Herbal supplement taking group (5 people). Placebo taking group (5 people)
    Herbal supplement taking group (35 people). Placebo taking group (35 people)
    گروه دریافت کننده مکمل گیاهی (5 نفر) گروه دریافت کننده دارونما (5 نفر)
    گروه دریافت کننده مکمل گیاهی (35 نفر) گروه دریافت کننده دارونما (35 نفر)
  • General information

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  • Intervention groups

    #1
    Intervention group: herbal supplement taking from a combination of 1000 mg of black myrobalan and 2000 mg of mastic and 3000 mg of sugarcane twice a day without water. The duration of herbal supplement taking is one week.
    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.
    گروه مداخله: دریافت مکمل گیاهی حاصل از ترکیب 1000 میلی گرم هلیله سیاه و 2000 میلی گرم مصطکی و 3000 میلی گرم شکر سرخ به صورت دو بار در روز و بدون آب. طول دوره مصرف مکمل گیاهی یک هفته می باشد.
    گروه مداخله: پروتکل درمانی مورد تأیید وزارت بهداشت در طول مدت بستری + دریافت مکمل گیاهی حاصل از ترکیب هلیله سیاه و مصطکی و شکر سرخ به صورت دو بار در روز و بدون آب در طول مدت بستری.
    #2
    Control group: Placebo taking twice a day Without water. The duration of placebo taking is one week.
    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.
    گروه کنترل: دریافت دارونما به صورت دو بار در روز و بدون آب. طول دوره مصرف دارونما یک هفته می باشد.
    گروه کنترل: پروتکل درمانی مورد تأیید وزارت بهداشت در طول مدت بستری + دریافت دارونما به صورت دو بار در روز و بدون آب در طول مدت بستری.
  • Recruitment centers

    #1
    Name of recruitment center - English: Peymanieh hospital
    Name of recruitment center - Persian: بیمارستان پیمانیه
    Full name of responsible person - English: Esmail Rayatdost
    Full name of responsible person - Persian: اسماعیل رعیت دوست
    Street address - English: Vali-e-Asr Ave., Peymaniyeh Hospital
    Street address - Persian: خیابان ولی عصر (عج)، بیمارستان پیمانیه
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 71 5427 7145
    Fax:
    Email: e.rayat.dost@gmail.com
    Web page address:
    Name of recruitment center - English: Peymanieh hospital
    Name of recruitment center - Persian: بیمارستان پیمانیه
    Full name of responsible person - English: Rahim raufi
    Full name of responsible person - Persian: رحیم رئوفی
    Street address - English: Vali-e-Asr Ave., Peymaniyeh Hospital
    Street address - Persian: خیابان ولی عصر (عج)، بیمارستان پیمانیه
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 71 5423 0010
    Fax:
    Email: sarahim1513@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Esmail Rayat dost
    Full name of responsible person - Persian: اسماعیل رعیت دوست
    Street address - English: Vali-e-Asr Ave., Peymaniyeh Hospital
    Street address - Persian: خیابان ولی عصر (عج)، بیمارستان پیمانیه
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 71 5427 7145
    Fax:
    Email: e.rayat.dost@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Kavous solhjou
    Full name of responsible person - Persian: کاووس صلح جو
    Street address - English: Jahrom University of Medical Sciences, Shahid Motahari Ave.
    Street address - Persian: خیابان شهید مطهری، دانشگاه علوم پزشکی، واحد پژوهش
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 71 5434 0405
    Fax:
    Email: solhjouk@yahoo.com
    Web page address:
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza hashemi shiri
    Full name of responsible person - Persian: علیرضا هاشمی شیری
    Position - English: Extern
    Position - Persian: اکسترن
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Motahari Ave., University of Medical Sciences, Research Unit
    Street address - Persian: خیابان شهید مطهری، دانشگاه علوم پزشکی، واحد پژوهش
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 902 001 0987
    Mobile: +98 916 493 0695
    Fax:
    Email: Entezar14arh@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Hashemi shiri
    Full name of responsible person - Persian: علیرضا هاشمی شیری
    Position - English: Extern
    Position - Persian: اکسترن
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Motahari Ave., University of Medical Sciences, Research Unit
    Street address - Persian: خیابان شهید مطهری، دانشگاه علوم پزشکی، واحد پژوهش
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 902 001 0987
    Mobile: +98 916 493 0695
    Fax:
    Email: Entezar14arh@gmail.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza hashemi shiri
    Full name of responsible person - Persian: علیرضا هاشمی شیری
    Position - English: Extern
    Position - Persian: اکسترن
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Motahari Ave., University of Medical Sciences, Research Unit
    Street address - Persian: خیابان شهید مطهری، دانشگاه علوم پزشکی، واحد پژوهش
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 902 001 0987
    Mobile: +98 916 493 0695
    Fax:
    Email: Entezar14arh@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Hashemi shiri
    Full name of responsible person - Persian: علیرضا هاشمی شیری
    Position - English: Extern
    Position - Persian: اکسترن
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Motahari Ave., University of Medical Sciences, Research Unit
    Street address - Persian: خیابان شهید مطهری، دانشگاه علوم پزشکی، واحد پژوهش
    City - English: Jahrom
    City - Persian: جهرم
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7414846199
    Phone: +98 902 001 0987
    Mobile: +98 916 493 0695
    Fax:
    Email: Entezar14arh@gmail.com
    Web page address:

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
Name
esmail rayat dost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5427 7145
Email address
e.rayatdost@jums.ac.ir
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Shahid Motahari Ave.
City
Jahrom
Province
Fars
Postal code
7414846199
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

Recruitment centers

1

Recruitment center
Name of recruitment center
Peymanieh hospital
Full name of responsible person
Rahim raufi
Street address
Vali-e-Asr Ave., Peymaniyeh Hospital
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5423 0010
Email
sarahim1513@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavous solhjou
Street address
Jahrom University of Medical Sciences, Shahid Motahari Ave.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
solhjouk@yahoo.com
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

Person responsible for general inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Alireza Hashemi shiri
Position
Extern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Motahari Ave., University of Medical Sciences, Research Unit
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 902 001 0987
Email
Entezar14arh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmail Rayat dost
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Vali-e-Asr Ave., Peymaniyeh Hospital
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5427 7145
Email
e.rayat.dost@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Alireza Hashemi shiri
Position
Extern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Motahari Ave., University of Medical Sciences, Research Unit
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 902 001 0987
Fax
Email
Entezar14arh@gmail.com

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
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