Evaluation of the effect of aqueous extract of violet on fever in patient with covid-19
Design
A clinical trial with a control group, with parallel group, one-sided blind,, randomized, phase 1 on 52 patients, was used for randomization of blocking and envelope.
Settings and conduct
Febrile COVID-19 patients in Imam Khomeini Hospital of Amol who used violet syrup in the treatment of fever.The only statistical consultant in the statistical analysis process will be blinded..
Participants/Inclusion and exclusion criteria
Willingness to participate in the study, confirming covid-19 with positive PCR;
Temperatures between 38.3°C and 40°C, patient's complete consciousness, lack of allergy to herbal medicines,
Not receiving and not using other methods of reducing fever in 4
hours ago, not pregnant, and having no history of surgery or head trauma,
Seizure
Intervention groups
Control group, including received
Ampoules 1 gram acetaminophen ampoule by intravenous infusion for 15 minutes and recording
The temperature is 30 and 60 minutes and the end is 4 hours. Will receive. In the test group
After recording the temperature, and receiving one gram acetaminophen injection by intravenous infusion for 15 minutes. 5 cc of Barij violet syrup will be used, then the temperature will be recorded at 30 and 60 minutes and at the end of 4 hours. For up to three days, follow-up and violet syrup will be given to patients every 8 hours and the patient's temperature will be recorded every 6 hours. In case of recurrence, acetaminophen injections will be repeated in both groups.
Main outcome variables
Fever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150916024047N6
Registration date:2022-04-16, 1401/01/27
Registration timing:retrospective
Last update:2022-04-16, 1401/01/27
Update count:0
Registration date
2022-04-16, 1401/01/27
Registrant information
Name
Hedayat Jafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 7268
Email address
hjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of aqueous extract of violet on fever in patient with covid-19
Public title
Evaluation of the effect extract of violet on fever patient with covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of covid 19 with positive PCR
Temperature between 38.3 to 40 ° C
Having a fever from the time of admission to 10 days
Complete patient consciousness
Lack of any sensitivity to herbal medicines,
Not receiving and not using Other help methods to reduce fever in 4 hours before
Exclusion criteria:
Sensitivity to violet syrup
Unwillingness to cooperate
Not being pregnant
Seizures
History of head trauma and brain tumor and history of brain surgery due to possible hypothalamus disorders
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 52 patients were selected by convenience sampling method and were randomly assigned to one of the two experimental groups (A) and control (B). According to the 6 possible modes of placing letters in quadruple blocks, these blocks are numbered with numbers from one to six (AABB1- ABBA2 - BABA3 - BBAA4 -ABAB5 ABAB6) then using Random Allocation Software 2.0 one of the numbers up to Six are randomly selected for 13 times. The four blocks are placed in 13 opaque numbered envelopes according to a random selection sequence, and these envelopes are sealed by a person outside the research team, respectively, and the patients are assigned to the relevant groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Faculty of Nursing, Midwifery., Vesal., Amir Mazandarani Stree., Sari t
City
Sari
Province
Mazandaran
Postal code
7815733971
Approval date
2021-06-16, 1400/03/26
Ethics committee reference number
IR.MAZUMS..REC.1400.8499
Health conditions studied
1
Description of health condition studied
COVID-19 Patients
ICD-10 code
U07.1
ICD-10 code description
COVID19, virus identified
Primary outcomes
1
Description
Fever
Timepoint
Q6h - 3day
Method of measurement
Before the intervention, patients' temperature is recorded with MICROLAB digital thermometer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, after recording the temperature and receiving acetaminophen ampoules, one gram intravenous infusion for 15 minutes and using 5 cc of violets barij extract prepared from the blue extract of Violets flower) with Product registration code no. 6599807159453166 from Bari j Essence Company, in people whose sweetness of syrup stimulates the throat due to red sugar, they can take the dose in half of the water supply. Lukewarm dissolves and drinks slowly will be used.Temperatures will be recorded at 30, 60 minutes and the end of 4 hours.The patients' falloff will continue for three days and in case of fever in the experimental group, in addition to acetaminophen injection, violet syrup will be given to patients every 8 hours up to three days and the patient's temperature will be recorded every 6 hours and in case of no fever, violet syrup will be discontinued.
Category
Treatment - Drugs
2
Description
The control group will receive routine measures including receiving 1g acetaminophen injection as intravenous infusion at 100 cc normal saline for 15 minutes. Follow-up will continue for up to 3 days and the patient's temperature will be recorded every 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazbital emam khomaini amol
Full name of responsible person
khadijeh omranifar
Street address
Haraz
City
Amol
Province
Mazandaran
Postal code
4615747845
Phone
+98 11 4422 1560
Email
mahsaomranifar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
dr.hedayat. jafary
Street address
Nasibeh School of Nursing and Midwifery، vesal، amir mazandarani
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 0602
Email
hedayat2003@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
DR.H. jafary
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery., Vesal., west Amir mazandarani,
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
009833350602
Email
hedayat2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
dr.Hedayat.jafari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal, Amir mazandarani
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
0981133350602
Email
hedayat2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
khadijeh omranifar
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Haraz
City
Amol
Province
Mazandaran
Postal code
4615747845
Phone
+98 11 4422 1560
Email
mahsaomranifar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient name information will be kept confidential
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
If the names of the people are not identifiable - and only the main consequences
When the data will become available and for how long
After the end of the study
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For researchers working in academic and scientific institutions
From where data/document is obtainable
mahsaomranifar@gmail.com
What processes are involved for a request to access data/document