Protocol summary
-
Study aim
-
Evaluating the therapeutic effect of Phyllanthus Emblica e on COVID 19 patients, a double blind clinical trial
-
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. Physician decision not to participate in the study 2. Severe liver disease 3. Known allergic reaction to Phyllanthus Emblica 4. Severe renal disease 5. Pregnant or breastfeeding women 6. Will be transferred to another hospital 7. Receipt of any another experimental treatment 8. Angiotensin converting enzyme (ACE) inhibitor users
-
Intervention groups
-
Main group will be received the drug of the study. Every sacher in main group contains 2 gram of Phyllanthus Emblica powder. Control group will be received placebo. Every sacher in control group contains 2 gram of starch powder. Patients should infuse the contents of one packet with 250 cc of boiling water for 10 minutes every 12 hours, then strain and sip
-
Main outcome variables
-
Virus polymerase reaction, fever, dyspnea, chill, cough, Chest X ray, chest CT scan, lymphocyte blood count, C_ reactive protein
General information
-
Reason for update
-
Correct typing error
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200404046937N2
Registration date:
2020-04-13, 1399/01/25
Registration timing:
prospective
Last update:
2020-08-01, 1399/05/11
Update count:
3
-
Registration date
-
2020-04-13, 1399/01/25
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-04-13, 1399/01/25
-
Expected recruitment end date
-
2020-06-14, 1399/03/25
-
Actual recruitment start date
-
2020-05-01, 1399/02/12
-
Actual recruitment end date
-
2020-05-22, 1399/03/02
-
Trial completion date
-
2020-06-01, 1399/03/12
-
Scientific title
-
Evaluating the therapeutic effect of Phyllanthus Emblica on COVID 19 patients, A double blind clinical trial
-
Public title
-
Evaluating the effect of Phyllanthus Emblica on COVID 19 patients
-
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 (axillar or oral temperature ≥ 38.0°) 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:
Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Severe liver disease
Known allergic reaction to Phyllanthus Emblica
Severe renal impairment
Pregnant or breastfeeding women
Transfer to another non-study hospital within the next 72 hours
Receipt of any experimental treatment for COVID 19 within the 30 days prior to the time of the screening evaluation
Angiotensin converting enzyme (ACE) inhibitor user
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
Actual sample size reached:
61
-
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 software, make a random sequence is by using statistical software. 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 (aluminium package). Phyllanthus Emblica 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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-04-04, 1399/01/16
-
Ethics committee reference number
-
IR.AJUMS.REC.1399.011
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 (10th day)
-
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
-
Cough
-
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
-
Lymphocyte blood count
-
Timepoint
-
The first day of the study and the end of the study (10th day)
-
Method of measurement
-
Cell counter
6
-
Description
-
C_reactive protein
-
Timepoint
-
The first day of the study and the end of the study (10th day)
-
Method of measurement
-
Agglutination kit
7
-
Description
-
Chest CT scan
-
Timepoint
-
The first day of the study and the end of the study (10th day)
-
Method of measurement
-
CT scan set
Intervention groups
1
-
Description
-
Intervention group: After routine treatment, the main group will be received the drug of the study. Drugs are in the sacher form. Every sacher contain 2 gram of Phyllanthus Emblica powder. For 10 days Patients should infuse the contents of one packet with 250 cc of boiling water for 10 minutes every 12 hours, then strain and sip
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: After routine treatment, the control group willl be received the placebo. They are in the sacher form. The contents of each package of placebo is 2 grams of starch powder. For 10 days, patients should infuse the contents of one packet with 250 cc of boiling water for 12 minutesevery 12 hours, then strain and sip.
-
Category
-
Placebo
1
-
Sponsor
-
-
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
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