The study of the effect of herbal drug Phyllanthus Emblica, Rosa Damascene, Althaea Officinalis and Honey in patient with covid 19 referring to Ahvaz Jundishapur university of Medical Science hospitals.
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Protocol summary
Inclusion criteria: 1. Age ≥18 years 2. Polymerase chain reaction (PCR) test confirmed infection with COVID 19. 3. Lung involvement in imaging 4. Hospitalized 5. Less than 8 days since illness onset 6. Willingness of study participant to accept randomization to any assigned treatment arm. 7. Must agree not to enroll in another study before 28th day of this study. Exclusion Criteria: 1. Receipt of any another experimental treatment 2. Severe liver disease 3. Known allergic reaction to drugs 4. Severe renal disease 5. Pregnant or breastfeeding women 6. Will be transferred to another hospital
Inclusion criteria: 1. Age ≥18 years 2. Polymerase chain reaction (PCR) test confirmed infection with COVID 19. 3. Lung involvement in imaging 4. Hospitalized 5. Less than 8 days since illness onset 6. Willingness of study participant to accept randomization to any assigned treatment arm. 7. Must agree not to enroll in another study before 28th day of this study. Exclusion Criteria: 1. Receipt of any another experimental treatment 2. Severe liver disease 3. Known allergic reaction to drugs 4. Severe renal disease 5. Pregnant or breastfeeding women 6. transferred to another hospital
Inclusion criteria: 1. Age ≥18 years 2. Polymerase chain reaction (PCR) test confirmed infection with COVID 19. 3. Lung involvement in imaging 4. Hospitalized 5. Less than 8 days since illness onset 6. Willingness of study participant to accept randomization to any assigned treatment arm. 7. Must agree not to enroll in another study before 28th day of this study. Exclusion Criteria: 1. Receipt of any another experimental treatment 2. Severe liver disease 3. Known allergic reaction to drugs 4. Severe renal disease 5. Pregnant or breastfeeding women 6. Will be transferred to another hospital
They received main drug contents of each drug package, including 30 grams of Amla fruit powder, 20 grams of Rose powder, 20 grams of Marshmallow powder and 110 grams of Honey, and patients take 4 grams of the drug every 6 hours. Each placebo package contains 90 grams of Starch and 90 grams of Sugar syrup, which patients should drink 4 grams every 8 hours
They receive medicine. 1000 g of amla plant powder soaked in rose water is mixed with 500 g of marshmallow powder, 500 g of rose powder and 5 kg of honey and then packed in 150 g cans. Control group: Placebo will receive 3500 g of starch powder. It mixes well with 3,500 grams of sugar syrup and is packaged in 150-gram cans, and patients take 5 grams of the drug or placebo every 6 hours.
They received main drug contentsreceive medicine. 1000 g of each drug packageamla plant powder soaked in rose water is mixed with 500 g of marshmallow powder, including 30500 g of rose powder and 5 kg of honey and then packed in 150 g cans. Control group: Placebo will receive 3500 g of starch powder. It mixes well with 3,500 grams of Amla fruit powder, 20 grams of Rose powder, 20 grams of Marshmallow powdersugar syrup and 110 grams of Honeyis packaged in 150-gram cans, and patients take 45 grams of the drug or placebo every 6 hours. Each placebo package contains 90 grams of Starch and 90 grams of Sugar syrup, which patients should drink 4 grams every 8 hours
گروه مداخله: دارو دریافت می کنند محتویات هر بسته دارویی شامل 30 گرم پودر میوه آمله، 20 گرم پودر گلسرخ، 20 گرم پودر گل ختمی و 110 گرم عسل می باشد و بیماران هر 6 ساعت 4 گرم از دارو را میل کنند گروه کنترل: پلاسبو دریافت خواهند کرد محتویات هر بسته ی پلاسبو حاوی 90 گرم نشاسته و 90 گرم شربت شکر می باشد که بیماران هر 6 ساعت 4 گرم میل کنند
گروه مداخله: دارو دریافت می کنند. 1000 گرم پودر گیاه آمله خیسانده در گلاب با 500 گرم پودر ختمی و 500 گرم پودر گلسرخ و 5کیلو گرم عسل مخلوط شده و سپس در قوطی های 150 گرمی بسته بندی می شود گروه کنترل: پلاسبو دریافت خواهند کرد 3500 گرم پودر نشاسته با 3500 گرم شربت شکر به خوبی مخلوط و در قوطی های 150 گرمی بسته بندی می شود و بیماران هر 6 ساعت 5 گرم از دارو یا پلاسبو را میل می کنند.
گروه مداخله: دارو دریافت می کنند محتویات هر بسته دارویی شامل 30. 1000 گرم پودر میوهگیاه آمله، 20 خیسانده در گلاب با 500 گرم پودر ختمی و 500 گرم پودر گلسرخ، 20 گرم پودر گل ختمی و 1105کیلو گرم عسل می باشدمخلوط شده و بیماران هر 6 ساعت 4 گرم از دارو را میل کنندسپس در قوطی های 150 گرمی بسته بندی می شود گروه کنترل: پلاسبو دریافت خواهند کرد محتویات هر بسته ی پلاسبو حاوی 903500 گرم پودر نشاسته و 90با 3500 گرم شربت شکر به خوبی مخلوط و در قوطی های 150 گرمی بسته بندی می باشد کهشود و بیماران هر 6 ساعت 45 گرم از دارو یا پلاسبو را میل می کنند.
Intervention groups
#1
Intervention group: patients will receive the main drug after treatment with routine medications. Each package of medicine contains 180 grams of medicine, which consists of a combination of 30 grams of Phyllanthus Emblica (Amla), 20 grams of Rosa Damascene (Rose), 20 grams of Althaea Officinalis (marshmallow) powder, which is well powdered and mixed with110 grams of Honey. Patients should eat 4 grams of the drug every 6 hours for 10 days
Intervention group: Patients in the target group will receive the target group drug after treatment with routine medications. To prepare the target drug, 1000 g of Amla fruit is soaked in rose water and then ground, then combined with 500 g of rose petal powder, 500 g of marshmallow powder and 5 kg of honey, and the ingredients are carefully mixed together. Stir slowly to form a homogeneous composition and the final product is an oral concoction that is packaged in suitable 150 g storage cans and patients will want 5 g of this drug every 6 hours.
Intervention group: patientsPatients in the target group will receive the maintarget group drug after treatment with routine medications. Each packageTo prepare the target drug, 1000 g of medicine contains 180 gramsAmla fruit is soaked in rose water and then ground, then combined with 500 g of medicine, which consists of a combination of 30 grams of Phyllanthus Emblica (Amla), 20 grams of Rosa Damascene (Rose), 20 grams of Althaea Officinalis (marshmallow)rose petal powder, which500 g of marshmallow powder and 5 kg of honey, and the ingredients are carefully mixed together. Stir slowly to form a homogeneous composition and the final product is well powderedan oral concoction that is packaged in suitable 150 g storage cans and mixed with110 gramspatients will want 5 g of Honey. Patients should eat 4 grams of thethis drug every 6 hours for 10 days.
گروه مداخله: بیماران گروه هدف پس از درمان با داروهای روتین بیماری، داروی گروه هدف را دریافت خواهند داشت. هر بسته دارو حاوی 180 گرم دارو بوده که از ترکیب 30 گرم آمله ، 20 گرم گلسرخ، 20 گرم گل ختمی که به خوبی پودر شده و با 110 گرم عسل مخلوط شده اند تشکیل شده . بیماران باید به مدت 10 روز هر 6 ساعت 4 گرم از محتویات دارو را میل کنند.
گروه مداخله: بیماران گروه هدف پس از درمان با داروهای روتین بیماری، داروی گروه هدف را دریافت خواهند داشت. برای تهیه داروی هدف 1000 گرم میوه گیاه آمله در گلاب خیسانه شده و سپس چرخ شده سپس با 500 گرم پودر گلبرگ گلسرخ و 500 گرم پودر گل ختمی و 5 کیلو گرم عسل با هم ترکیب می شوند و مواد به دقت با هم مخلوط شده و به آهستگی هم زده می شودتا یک ترکیب یکنواخت ایجاد شود و محصول نهایی یک معجون خوراکی می باشد که در قوطی های مناسب 150 گرمی نگهداری دارو بسته بندی می شود و بیماران هر 6 ساعت 5 گرم از این دارو را میل خواهند نمود.
گروه مداخله: بیماران گروه هدف پس از درمان با داروهای روتین بیماری، داروی گروه هدف را دریافت خواهند داشت. هر بسته دارو حاوی 180برای تهیه داروی هدف 1000 گرم دارو بوده که از ترکیب 30میوه گیاه آمله در گلاب خیسانه شده و سپس چرخ شده سپس با 500 گرم آمله ، 20پودر گلبرگ گلسرخ و 500 گرم گلسرخ، 20 گرمپودر گل ختمی کهو 5 کیلو گرم عسل با هم ترکیب می شوند و مواد به خوبی پودردقت با هم مخلوط شده و با 110 گرم عسل مخلوط شده اند تشکیل شده .به آهستگی هم زده می شودتا یک ترکیب یکنواخت ایجاد شود و محصول نهایی یک معجون خوراکی می باشد که در قوطی های مناسب 150 گرمی نگهداری دارو بسته بندی می شود و بیماران باید به مدت 10 روز هر 6 ساعت 45 گرم از محتویاتاین دارو را میل کنندخواهند نمود.
#2
Control group: After being treated with routine medications. They will be treated with placebo. The contents of each placebo package include 90 grams of starch powder and 90 grams of sugar syrup, which is completely similar to the main drug with its natural and allowable color. Patients should take 4 grams of the drug every 6 hours every 10 days
Control group: Patients will be treated with placebo after treatment with routine medications. To prepare a placebo, 3500 g of starch powder with 3500 g of sugar syrup are mixed well and with natural and authorized color, it is completely similar to the main medicine and then it is packed in 150 g packages and patients should take 5 g of medicine every 6 hours.
Control group: After being treated with routine medications. TheyPatients will be treated with placebo after treatment with routine medications. The contents of eachTo prepare a placebo package include 90 grams, 3500 g of starch powder and 90 gramswith 3500 g of sugar syrup are mixed well and with natural and authorized color, whichit is completely similar to the main drug with its naturalmedicine and allowable color. Patientsthen it is packed in 150 g packages and patients should take 4 grams5 g of the drugmedicine every 6 hours every 10 days.
گروه کنترل: پس از اینکه تحت درمان با داروهای روتین بیماری قرار گرفتند. تحت درمان با پلاسبو قرار خواهند گرفت. محتویات هر بسته پلاسبو شامل 90 گرم پودر نشاسته و 90 گرم شربت شکر بوده که با رنگ طبیعی و مجاز کاملا شبیه داروی اصلی گردیده بیماران باید به مدت 10 روزهر 6 ساعت 4 گرم از دارو را میل نمایند.
گروه کنترل: بیماران پس از درمان با داروهای روتین بیماری، تحت درمان با پلاسبو قرار خواهند گرفت. برای تهیه پلاسبو 3500 گرم پودر نشاسته با 3500 گرم شربت شکر به خوبی مخلوط شده و با رنگ طبیعی و مجاز کاملا شبیه داروی اصلی گردیده و سپس در بسته های 150 گرمی بسته بندی می شود و بیماران باید هر 6 ساعت 5 گرم از دارو را میل نمایند.
گروه کنترل: بیماران پس از اینکه تحت درمان با داروهای روتین بیماری قرار گرفتند.، تحت درمان با پلاسبو قرار خواهند گرفت. محتویات هر بستهبرای تهیه پلاسبو شامل 903500 گرم پودر نشاسته و 90با 3500 گرم شربت شکر بوده کهبه خوبی مخلوط شده و با رنگ طبیعی و مجاز کاملا شبیه داروی اصلی گردیده و سپس در بسته های 150 گرمی بسته بندی می شود و بیماران باید به مدت 10 روزهرهر 6 ساعت 45 گرم از دارو را میل نمایند.
Protocol summary
Study aim
The study of the effect of herbal drug phyllanthus Emblica, Rosa Damascene, Althaea Officinalis and Honey in patient with covid 19 referring to Ahvaz Jundishapur University of Medical Science hospitals.
Design
Randomize double blind clinical trial, with control group, with a sample size of 60 people, with parallel groups, Phase 3 of Clinical trial
Settings and conduct
The place of the study is Ahvaz University of medical science hospitals, simple sampling of patients with random allocation, double blind clinical trial, used drug and placebo, Supervisor and participants are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age ≥18 years 2. Polymerase chain reaction (PCR) test confirmed infection with COVID 19. 3. Lung involvement in imaging 4. Hospitalized 5. Less than 8 days since illness onset 6. Willingness of study participant to accept randomization to any assigned treatment arm. 7. Must agree not to enroll in another study before 28th day of this study. Exclusion Criteria: 1. Receipt of any another experimental treatment 2. Severe liver disease 3. Known allergic reaction to drugs 4. Severe renal disease 5. Pregnant or breastfeeding women 6. transferred to another hospital
Intervention groups
They receive medicine. 1000 g of amla plant powder soaked in rose water is mixed with 500 g of marshmallow powder, 500 g of rose powder and 5 kg of honey and then packed in 150 g cans. Control group: Placebo will receive 3500 g of starch powder. It mixes well with 3,500 grams of sugar syrup and is packaged in 150-gram cans, and patients take 5 grams of the drug or placebo every 6 hours.
The study of the effect of herbal drug Phyllanthus Emblica, Rosa Damascene, Althaea Officinalis and Honey in patient with covid 19 referring to Ahvaz Jundishapur university of Medical Science hospitals.
Public title
Evaluating the effect of Phyllanthus Emblica, Rosa Damascene, Marshmallow and Honey on COVID 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years
Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging
Hospitalized with: Fever or Respiratory rate >24/min Or Cough
Less than 8 days since illness onset
Willingness of study participant to accept randomization to any assigned treatment arm
Acceptance of non-participation in another study before the 28th day of the study
Exclusion criteria:
Receipt of any experimental treatment for COVID 19 within the 30 days prior to the time of the screening evaluation
Severe liver disease
Known allergic reaction to drugs
Severe renal disease
Pregnant or breastfeeding women
Transfer to another hospital within the next 72 hours
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit and randomization tools are statistical soft ware, make a random sequence is by using statistical soft ware allocation concealment is by assigning unique codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: Supervisor and the participants are blind to the prescription drug of the target group and the control group The drugs of both groups are distinguished in the same form. phyllanthus Emblica, Rosa damascene, Honey and Marshmallow have no significant smell and placebo will be the same color as the medicine by using allowed color. Also there is no significant difference between drug and placebo taste. The package are separated by mentioning the number. The list of numbers will be provided to the statistical consultant and then the data will be analyzed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical
Street address
Ethics committee, main building, Ahvaz University of medical science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6133744151
Approval date
2020-05-29, 1399/03/09
Ethics committee reference number
IR.AJUMS.REC.1399.208
Health conditions studied
1
Description of health condition studied
COVID 19
ICD-10 code
U07.1
ICD-10 code description
Corona virus infection, unspecified
Primary outcomes
1
Description
Viral diagnostic test
Timepoint
The first day of the study and the end of the study
Method of measurement
Polymerase chain reaction
Secondary outcomes
1
Description
Fever
Timepoint
Daily
Method of measurement
Thermometer
2
Description
Chill
Timepoint
Daily
Method of measurement
Patients interview and patient file
3
Description
Respiratory Rate
Timepoint
Daily
Method of measurement
Patients interview and patient file
4
Description
Dyspnea
Timepoint
Daily
Method of measurement
Patients interview and patient file
5
Description
Cough
Timepoint
Daily
Method of measurement
Patients interview and patient file
6
Description
Body Pain
Timepoint
Daily
Method of measurement
Patients interview and patient file
7
Description
Weakness
Timepoint
Daily
Method of measurement
Patients interview and patient file
8
Description
Lymphocyte blood count
Timepoint
The first day of the study and the end of the
Method of measurement
Cell counter
9
Description
C_reactive protein
Timepoint
The first day of the study and the end of the
Method of measurement
Agglutination Kit
10
Description
Erythrocyte sedimentation Rate
Timepoint
The first day of the study and the end of the study
Method of measurement
Wester Green
11
Description
Neutrophyle blood count
Timepoint
The first day of the study and the end of the study
Method of measurement
Cell counter
12
Description
Platelet
Timepoint
The first day of the study and the end of the study
Method of measurement
Cell counter
13
Description
Chest CT Scan
Timepoint
The first day of the study and the end of the study
Method of measurement
CT scan set
Intervention groups
1
Description
Intervention group: Patients in the target group will receive the target group drug after treatment with routine medications. To prepare the target drug, 1000 g of Amla fruit is soaked in rose water and then ground, then combined with 500 g of rose petal powder, 500 g of marshmallow powder and 5 kg of honey, and the ingredients are carefully mixed together. Stir slowly to form a homogeneous composition and the final product is an oral concoction that is packaged in suitable 150 g storage cans and patients will want 5 g of this drug every 6 hours.
Category
Treatment - Drugs
2
Description
Control group: Patients will be treated with placebo after treatment with routine medications. To prepare a placebo, 3500 g of starch powder with 3500 g of sugar syrup are mixed well and with natural and authorized color, it is completely similar to the main medicine and then it is packed in 150 g packages and patients should take 5 g of medicine every 6 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital, Ahvaz
Full name of responsible person
Mehran Varnaseri Ghandali
Street address
Sina hospital, 5th Gandomkar st, Koot Abdollah Ave
City
Ahvaz
Province
Khouzestan
Postal code
6155819953
Phone
+98 61 3555 0592
Email
drvarnasseri.m@gmail.com
2
Recruitment center
Name of recruitment center
Razi hospital, Ahvaz
Full name of responsible person
Mehran Varnaseri Ghandali
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasseri.m@gmail.com
3
Recruitment center
Name of recruitment center
Taleghani hospital, Ahvaz
Full name of responsible person
Mehran Varnaseri Ghandali
Street address
Taleghani hospital, Mostaan Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514988
Phone
+98 61 3333 0927
Email
drvarnasseri.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Main building, Ahvaz University of Medical Science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3311 3815
Email
Badavi-m@ajums.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
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnaseri Ghandali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasseri.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnaseri Ghandali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasseri.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnaseri Ghandali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasseri.m@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