Efficacy evaluation of an herbal compound “Fluherb” on clinical symptoms and paraclinical parameters in highly suspected COVID-19 patients: a controlled randomized clinical trial.
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Protocol summary
This study consists of two groups. Intervention group will receive a herbal compound so-called Fluherb containing extracts of purslane, Plantain, Elderberry, licorice and turmeric prepared in suspension dosage form. The control group received a placebo syrup. The intervention period is five days and the drug will be administered orally in three divided doses. Both groups receive all current treatments and will be matched according to clinical status.
This study consists of two groups. Intervention group will receive a herbal compound so-called Fluherb containing extracts of purslane, Plantain, hyssop, licorice and turmeric prepared in suspension dosage form. The control group received a placebo syrup. The intervention period is five days and the drug will be administered orally in three divided doses. Both groups receive all current treatments and will be matched according to clinical status.
This study consists of two groups. Intervention group will receive a herbal compound so-called Fluherb containing extracts of purslane, Plantain, Elderberryhyssop, licorice and turmeric prepared in suspension dosage form. The control group received a placebo syrup. The intervention period is five days and the drug will be administered orally in three divided doses. Both groups receive all current treatments and will be matched according to clinical status.
این مطالعه مشتمل بر دو گروه می باشد. گروه مداخله یک ترکیب گیاهی با نام استعاری فلوهرب مشتمل بر عصاره گیاهان خرفه، بارهنگ، آقطی، شیرین بیان و زردچوبه که به صورت سوسپانسیون آماده شده دریافت خواهند نمود. گروه کنترل یک شربت پلاسبو میگیرند. مدت مداخله پنج روز بوده و دارو در سه دوز منقسم به صورت خوراکی تجویز خواهد شد. هر دو گروه از تمامی درمانهای رایج برخوردار بوده و به لحاظ وضعیت بالینی همسان سازی خواهند شد.
این مطالعه مشتمل بر دو گروه می باشد. گروه مداخله یک ترکیب گیاهی با نام استعاری فلوهرب مشتمل بر عصاره گیاهان خرفه، بارهنگ، زوفا، شیرین بیان و زردچوبه که به صورت سوسپانسیون آماده شده دریافت خواهند نمود. گروه کنترل یک شربت پلاسبو میگیرند. مدت مداخله پنج روز بوده و دارو در سه دوز منقسم به صورت خوراکی تجویز خواهد شد. هر دو گروه از تمامی درمانهای رایج برخوردار بوده و به لحاظ وضعیت بالینی همسان سازی خواهند شد.
این مطالعه مشتمل بر دو گروه می باشد. گروه مداخله یک ترکیب گیاهی با نام استعاری فلوهرب مشتمل بر عصاره گیاهان خرفه، بارهنگ، آقطیزوفا، شیرین بیان و زردچوبه که به صورت سوسپانسیون آماده شده دریافت خواهند نمود. گروه کنترل یک شربت پلاسبو میگیرند. مدت مداخله پنج روز بوده و دارو در سه دوز منقسم به صورت خوراکی تجویز خواهد شد. هر دو گروه از تمامی درمانهای رایج برخوردار بوده و به لحاظ وضعیت بالینی همسان سازی خواهند شد.
General information
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60
3060
2020-04-29, 1399/02/10
2020-05-09, 1399/02/20
2020-0405-2909 00:00:00
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The expiration date of the study was changed due to problems in patient selection and hospital ward restrictions. The elderberry fruit available in the market is not of good quality and in the initial evaluation it seemed that the cyanide level is higher than the standard, so the leaves of the hyssop were replaced and instead of hydroethonolic extract, a more safe aqueous extract was used. In addition, due to the low quality of the plantain leaves in the market, plantain seed were used instead of its leaves.
The expiration date of the study was changed due to problems in patient selection and hospital ward restrictions. The elderberry fruit available in the market is not of good quality and in the initial evaluation it seemed that the cyanide level is higher than the standard, so the leaves of the hyssop were replaced and instead of hydroethonolic extract, a more safe aqueous extract was used. In addition, due to the low quality of the plantain leaves in the market, plantain seed were used instead of its leaves.
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1- تاریخ پایان بیمارگیری به دلیلی مشکلاتی که در انتخاب بیماران و محدودیت ورود به بخشهای بستری وجود داشت تغییر کرد. (بخش اطلاعات عمومی مطالعه)
2- میوه آقطی موجود در بازار از کیفیت مناسب برخوردار نبوده و در ارزیابی اولیه به نظر رسید که سطح سیانید بالایی دارد لذا برگ گیاه زوفا جایگزین شد و به جای عصاره آبی الکلی کلا از عصاره آبی که ایمنی بیشتری دارد استفاده شد. ضمنا با توجه به کیفیت پایین برگهای بارهنگ موجود در بازار از بزر بارهنگ به جای برگ آن استفاده شد. (بخش شرح مداخله)
1- تاریخ پایان بیمارگیری به دلیلی مشکلاتی که در انتخاب بیماران و محدودیت ورود به بخشهای بستری وجود داشت تغییر کرد. (بخش اطلاعات عمومی مطالعه) 2- میوه آقطی موجود در بازار از کیفیت مناسب برخوردار نبوده و در ارزیابی اولیه به نظر رسید که سطح سیانید بالایی دارد لذا برگ گیاه زوفا جایگزین شد و به جای عصاره آبی الکلی کلا از عصاره آبی که ایمنی بیشتری دارد استفاده شد. ضمنا با توجه به کیفیت پایین برگهای بارهنگ موجود در بازار از بزر بارهنگ به جای برگ آن استفاده شد. (بخش شرح مداخله)
بررسی اثر ترکیب گیاهی «فلوهرب» بر علایم کلینیکی و پاراکلینیکی بیماران قویا مشکوک به کووید-19: یک کارآزمایی بالینی کنترل دار تصادفی شده
بررسی اثر ترکیب گیاهی «فلوهرب» بر علایم کلینیکی و پاراکلینیکی بیماران قویا مشکوک به کووید-19( COVID-19): یک کارآزمایی بالینی کنترل دار تصادفی شده
بررسی اثر ترکیب گیاهی «فلوهرب» بر علایم کلینیکی و پاراکلینیکی بیماران قویا مشکوک به کووید-19( COVID-19): یک کارآزمایی بالینی کنترل دار تصادفی شده
Intervention groups
#1
Intervention group: This group will receive routine treatments for COVID-19 disease and will receive a suspension of extract of five herbs. Patients will receive a combination consisted of macerated hydroethanolic extract of 6 grams of elderberry fruit, 10 grams of Plantain leaf, 10 grams of purslane seed , 10 grams of licorice root and 5 grams of turmeric, orally, in three divided doses daily. The intervention duration is five days.
Intervention group: This group will receive routine treatments for COVID-19 disease and will receive a suspension of extract of five herbs. Patients will receive a combination consisted of aqueous extract of 10 grams of hyssop leaf, 5 grams of Plantain seed, 10 grams of purslane seed , 10 grams of licorice root and 5 grams of turmeric, orally, in three divided doses daily. The intervention duration is five days.
Intervention group: This group will receive routine treatments for COVID-19 disease and will receive a suspension of extract of five herbs. Patients will receive a combination consisted of macerated hydroethanolicaqueous extract of 6 grams of elderberry fruit, 10 grams of hyssop leaf, 5 grams of Plantain leafseed, 10 grams of purslane seed , 10 grams of licorice root and 5 grams of turmeric, orally, in three divided doses daily. The intervention duration is five days.
گروه مداخله: این گروه درمانهای رایج بیماری کووید-19 را دریافت خواهند کرد و علاوه بر آن سوسپانسیونی که از عصاره پنج گیاه تهیه شده است مصرف خواهند کرد. بیماران روزانه معادل عصاره آبی الکلی خیسانده 5 گرم میوه آقطی، 10گرم برگ بارهنگ، 10گرم تخم تخم خرفه ، 10گرم ریشه شیرین بیان و 5 گرم زردچوبه دریافت خواهند نمود که در سه دوز منقسم به صورت خوراکی تجویز خواهد شد.طول مدت مداخله پنج روز است.
گروه مداخله: این گروه درمانهای رایج بیماری کووید-19 را دریافت خواهند کرد و علاوه بر آن سوسپانسیونی که از عصاره پنج گیاه تهیه شده است مصرف خواهند کرد. بیماران روزانه معادل عصاره آبی 10 گرم برگ زوفا، 5 گرم بزر بارهنگ، 10گرم تخم خرفه ، 10گرم ریشه شیرین بیان و 5 گرم زردچوبه دریافت خواهند نمود که در سه دوز منقسم به صورت خوراکی تجویز خواهد شد.طول مدت مداخله پنج روز است.
گروه مداخله: این گروه درمانهای رایج بیماری کووید-19 را دریافت خواهند کرد و علاوه بر آن سوسپانسیونی که از عصاره پنج گیاه تهیه شده است مصرف خواهند کرد. بیماران روزانه معادل عصاره آبی الکلی خیسانده10 گرم برگ زوفا، 5 گرم میوه آقطی، 10گرم برگبزر بارهنگ، 10گرم تخم تخم خرفه ، 10گرم ریشه شیرین بیان و 5 گرم زردچوبه دریافت خواهند نمود که در سه دوز منقسم به صورت خوراکی تجویز خواهد شد.طول مدت مداخله پنج روز است.
Recruitment centers
#1
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Mahdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Street address - English: Imam Reza sq.
Street address - Persian: میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177745346
Phone: +98 51 3854 3031
Fax:
Email: yousefim@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Mahdi Yousefi
Full name of responsible person - Persian: مهدی یوسفی
Street address - English: Imam Reza square
Street address - Persian: میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177745346
Phone: +98 51 3854 3031
Fax:
Email: yousefim@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: Mahdi Yousefi Full name of responsible person - Persian: مهدی یوسفی Street address - English: Imam Reza sq.square Street address - Persian: میدان امام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177745346 Phone: +98 51 3854 3031 Fax: Email: yousefim@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: Daneshgah Ave.
Street address - Persian: خیابان دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: RIS@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: Daneshgah avenue
Street address - Persian: خیابان دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: RIS@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mohsen Tafaghodi Full name of responsible person - Persian: دکتر محسن تفقدی Street address - English: Daneshgah Ave.avenue Street address - Persian: خیابان دانشگاه City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3841 2081 Fax: Email: RIS@mums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effect of a herbal compound on patients with clinical and CT scan findings strongly suspected of COVID-19
Design
This study is a randomized controlled clinical trial in which patients will be simply selected from hospitalized patients with corona. Individuals with eligibility criteria will be randomly divided into two groups of intervention and control, and 30 patients will be enrolled in each group. The study is three-blinded and the patient, the nurse giving the medication, the data collector, and the data analyzer are not aware of the type of assignment.
Settings and conduct
This study will be carried out at Imam Reza Hospital, one of the hospitals affiliated to Mashhad University of Medical Sciences. This hospital has been assigned for corona patients. This research will be carried out in March and April of 2020.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Hospitalized patients who are suspected to COVID- 19 based on clinical symptoms and computed tomography findings; Clinically classified as moderate and severe; No organ damage; age under 70 years; They are stable in cardiovascular status.
Non-inclusion criteria:
Pregnant and lactating women;
End stage patients
Intervention groups
This study consists of two groups. Intervention group will receive a herbal compound so-called Fluherb containing extracts of purslane, Plantain, hyssop, licorice and turmeric prepared in suspension dosage form. The control group received a placebo syrup. The intervention period is five days and the drug will be administered orally in three divided doses. Both groups receive all current treatments and will be matched according to clinical status.
Main outcome variables
Changes in clinical conditions and severity of disease
General information
Reason for update
The expiration date of the study was changed due to problems in patient selection and hospital ward restrictions. The elderberry fruit available in the market is not of good quality and in the initial evaluation it seemed that the cyanide level is higher than the standard, so the leaves of the hyssop were replaced and instead of hydroethonolic extract, a more safe aqueous extract was used. In addition, due to the low quality of the plantain leaves in the market, plantain seed were used instead of its leaves.
Acronym
IRCT registration information
IRCT registration number:IRCT20200323046841N1
Registration date:2020-03-28, 1399/01/09
Registration timing:registered_while_recruiting
Last update:2020-04-11, 1399/01/23
Update count:1
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Mahdi Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 6148
Email address
yousefim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-28, 1399/01/09
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy evaluation of an herbal compound “Fluherb” on clinical symptoms and paraclinical parameters in highly suspected COVID-19 patients: a controlled randomized clinical trial.
Public title
Efficacy evaluation of an herbal compound in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with clinical and CT scan findings strongly suspected of COVID -19
Relative stability in cardiovascular status
Moderate and severe cases
No organ damage
Exclusion criteria:
Pregnant and lactating women
End stage patients
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients will be informed by consent form that they would either be in the intervention group or the control group, but they won't be aware of the type of medication. Nurses who supply the drug are also unaware of its content because the appearance, taste, color, and prescription of the drug are similar, but the code on the drug will be different. The written codes on the drugs are random and only the pharmacist's partner is aware of the drug type and the inserted code on it. The patient data collector and the project statistical partner are also unaware of the type of intervention. As the control group uses placebo, which is similar in appearance, taste, color, and prescription, patients will be unaware of the type of drug being administered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Persian and Complementary Medicine; University Campus; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177745346
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.MUMS.REC.1398.315
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
Changing the patient's clinical status in the COVID-19 clinical classification table
Timepoint
Before and after intervention
Method of measurement
Clinical and Paraclinical Indicators in COVID-19 Classification Table
Secondary outcomes
1
Description
Cell blood count
Timepoint
Before and after the intervention
Method of measurement
Cell conuter
2
Description
Liver enzymes
Timepoint
Before and after the intervention
Method of measurement
spectrometer
Intervention groups
1
Description
Intervention group: This group will receive routine treatments for COVID-19 disease and will receive a suspension of extract of five herbs. Patients will receive a combination consisted of aqueous extract of 10 grams of hyssop leaf, 5 grams of Plantain seed, 10 grams of purslane seed , 10 grams of licorice root and 5 grams of turmeric, orally, in three divided doses daily. The intervention duration is five days.
Category
Treatment - Drugs
2
Description
Control group: This group receive routine treatments for COVID-19 disease and placebo. Placebo will be given as an oral syrup, three servings a day. For the placebo syrup, a non-absorbable sweetened drop of stevia (a product from a pharmaceutical company), authorized oral dyes are used to make the color and taste relatively similar to the original drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahdi Yousefi
Street address
Imam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177745346
Phone
+98 51 3854 3031
Email
yousefim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
RIS@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian and Complementary Medicine; University Campus; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177745346
Phone
0091 51 38848930
Email
yousefim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian and Complementary Medicine; University Campus; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177745346
Phone
+98 51 3876 6148
Fax
Email
yousefim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian and Complementary Medicine; University Campus; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177745346
Phone
+98 51 3876 6148
Fax
Email
yousefim@mums.ac.ir
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