View older revisions Content changed at 2021-06-02, 1400/03/12

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.
Main outcome variables
virus polymerase reaction, fever,respiratory rate, dyspnea, chill, cough, Body Pain, Weakness, chest CT scan, lymphocyte blood count, neutrophil blood count, platelet, C _ reactive protein, erythrocyte sedimentation rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200404046937N3
Registration date: 2020-06-25, 1399/04/05
Registration timing: prospective

Last update: 2021-06-02, 1400/03/12
Update count: 1
Registration date
2020-06-25, 1399/04/05
Registrant information
Name
Mehran Varnaseri ghandali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7446
Email address
varnaseri-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-27, 1399/04/07
Expected recruitment end date
2020-07-28, 1399/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
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