Determining the effectiveness and safety of Gallecina(R) capsule in the treatment of outpatients Covid 19 and also evaluating its effects on reducing mortality or hospitalization due to (SARS-CoV-2)
Design
This is a double-blind clinical study of phases 2-3. This study will be performed on 140 patients who are divided into two groups. Randomly, a group of outpatients with Covid-19 were given a 90 mg capsule of Gallecina (R) (made by SamiSaz Co.) three times a day and a group of placebo capsules for 10 days with common medications. The blocking method and randomization site "Randomization.com" are used for randomization. Patients are followed up during this period in terms of clinical symptoms and severity of the disease and the need for hospitalization.
Settings and conduct
This study is performed in 16-h clinics of Covid-19 in Mashhad. Physician, patient, and data analyst are unaware of the medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Outpatients with COVID-19;
Confirming RT-PCR test for SARS-CoV-2;
Blood oxygen saturation more than 90%;
Age 18-60 years
Exclusion criteria:
Pregnant women;
Breastfeeding women
Intervention groups
Placebo group: receiving common treatments + placebo of Gallecina (R) capsule (made by SamiSaz Co.) three times a day / Intervention group: receiving common treatments + 90 mg capsule of Gallecina (R) (made by SamiSaz Co.) three times a day
Main outcome variables
he rate of recovery time from the time of randomization of patients to the improvement of clinical symptoms including fever, cough and myalgia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N12
Registration date:2022-02-21, 1400/12/02
Registration timing:prospective
Last update:2022-02-21, 1400/12/02
Update count:0
Registration date
2022-02-21, 1400/12/02
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness and safety of Gallecina(R) capsule on the clinical symptoms of outpatients with COVID-19
Public title
Gallecina(R) capsule in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatients with COVID-19
Confirmed with RT-PCR
SPO2 more than 90%
Age between 18 to 60 years old
Exclusion criteria:
Pregnant women
Breastfeeding women
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The volume of each block will be 4. Then write a list of blocks and assign numbers to them, for example (AABB (1) - BBAA (2) - BABA (3) - BAAB (4)) which according to the sample size of 140 people, we have 35 blocks. Then, random numbers between one and 35 are selected according to the Randomization.com randomization site, and finally, the treatment allocation list is determined based on random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the use of a placebo similar to interventional therapy, the physician associated with the participants and participants will not be informed of the assigned treatment and also the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-11-09, 1400/08/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.550
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Time to recover from illness based on questionnaire
Timepoint
Before intervention and 3, 7 and 10 days after beginning the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: receiving common treatments, including adult cold two tablets every eight hours, one tablespoon of diphenhydramine syrup every 8 hours, vitamin C 1000 mg effervescent + placebo of Gallecina (R) capsule (made by SamiSaz Co.) three times a day
Category
Placebo
2
Description
Intervention group: Intervention group: receiving common treatments, including adult cold two tablets every eight hours, one tablespoon of diphenhydramine syrup every 8 hours, vitamin C 1000 mg effervescent + 90 mg capsule of Gallecina (R) (made by SamiSaz Co.) three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Reza Askari
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
askariv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghaiour Mobarhan
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
SamiSaz Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.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
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