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Evaluation of the effect of Afsantin in the treatment of COVID 19 patients

Protocol summary

Study aim
Evaluation of the effect of Afsantin in the treatment of COVID 19 patients
Design
This clinical trial was performed on 80 patients, divided into two groups of 40, including a control group and parallel groups. This study is Double-blind and block randomization method is used.
Settings and conduct
The field of work is clinical - internal. This study is performed in the Tohid Hospital in Sanandaj. Patients, physicians, and nurses who evaluate the outcomes will be blind to the groups studied.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Confirmed diagnosis of COVID19 with RT-PCR, Hospitalized patients, Ventilator independent patients Exclusion Criteria: Pregnancy, Breastfeeding, Diabetes, Severe renal failure, Metabolic acidosis, Severe respiratory failure, Taking anticoagulants
Intervention groups
Patients in both groups receive the treatment based on the Covid-19 National Guidelines. Patients in the intervention group, in addition to the standard treatment protocol, receive Afsantin Capsule in the form of 1000 mg capsules four times a day for 14 days and the control group also receives placebo according to the above method.
Main outcome variables
Fever, Cough, Muscle pain, Blood oxygen saturation percentage, CRP, CBC, Respiratory Rate, Heart Rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190415043279N6
Registration date: 2020-07-24, 1399/05/03
Registration timing: registered_while_recruiting

Last update: 2020-07-24, 1399/05/03
Update count: 0
Registration date
2020-07-24, 1399/05/03
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Afsantin in the treatment of COVID 19 patients
Public title
Evaluation of the effect of Afsantin on COVID 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive confirmation of Covid 19 based on RT-PCR results Hospitalized patients Ventilator independent patients
Exclusion criteria:
Pregnancy Breastfeeding Diabetes Severe renal failure Metabolic acidosis Severe respiratory failure Taking anticoagulants
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive Afsantin Capsule and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.MUK.REC.1399.048

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Fever
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Thermometer

2

Description
Cough
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

3

Description
Muscle pain
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Questionnaire

4

Description
C Reactive Protein (CRP)
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Agglutination

5

Description
Blood oxygen saturation percentage
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Pulse oximeter

6

Description
CBC
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Cell Counter

7

Description
Respiratory Rate
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
By observing the occurrence of breaths

8

Description
Heart Rate
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Afsantin capsule is taken as a 1000 mg soft capsule four times a day for 14 days.
Category
Placebo

2

Description
Control group: The placebo is taken as a capsule four times a day for 14 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Noshad Mohammadi
Street address
Tohid Hospital, Geriashan Ave
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3366 4645
Email
noshad.50@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Noshad Mohammadi
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
noshad.50@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sabah Hasani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonology
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
S.hasani@muk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Pezhman Sharifi
Position
مربی
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Research Department, Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3324 9435
Fax
+98 87 3324 9435
Email
p.sharifi@muk.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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