Protocol summary
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Study aim
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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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Design
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Randomize double blind clinical trial, with control group, with a sample size of 60 people, with parallel groups, Phase 3 of Clinical trial
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-06-25, 1399/04/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-27, 1399/04/07
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Expected recruitment end date
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2020-07-28, 1399/05/07
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluating the effect of Phyllanthus Emblica, Rosa Damascene, Marshmallow and Honey on COVID 19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-29, 1399/03/09
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Ethics committee reference number
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IR.AJUMS.REC.1399.208
Health conditions studied
1
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Description of health condition studied
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COVID 19
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ICD-10 code
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U07.1
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ICD-10 code description
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Corona virus infection, unspecified
Primary outcomes
1
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Description
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Viral diagnostic test
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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Polymerase chain reaction
Secondary outcomes
1
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Description
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Fever
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Timepoint
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Daily
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Method of measurement
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Thermometer
2
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Description
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Chill
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
3
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Description
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Respiratory Rate
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
4
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Description
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Dyspnea
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
5
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Description
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Cough
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
6
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Description
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Body Pain
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
7
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Description
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Weakness
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
8
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Description
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Lymphocyte blood count
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Timepoint
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The first day of the study and the end of the
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Method of measurement
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Cell counter
9
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Description
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C_reactive protein
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Timepoint
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The first day of the study and the end of the
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Method of measurement
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Agglutination Kit
10
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Description
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Erythrocyte sedimentation Rate
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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Wester Green
11
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Description
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Neutrophyle blood count
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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Cell counter
12
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Description
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Platelet
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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Cell counter
13
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Description
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Chest CT Scan
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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CT scan set
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available