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Curmeric-Prevention-COVID-19-Health Workers-University Hospital General Calixto Garcia
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24 November 2020 - 1:26pm
by Gladys
24 March 2023 - 7:09am
by Gladys
Changes to
Intervention code
Curcuma
Curcuma
Administration, Oral
Administration, Oral
+
Plant Extracts
Changes to
Record Verification Date
-
2020/
11
/
24
+
2020/
12
/
21
Changes to
Next update date
-
2021/
11
/
24
+
2021/
12
/
21
Revision of 24 March 2023 - 7:09am:
Curmeric-Prevention-COVID-19-Health Workers-University Hospital General Calixto Garcia
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Observational study about the prophylactic effect and the security of Curmeric in COVID- 19 administered to the health workers in the University Hospital General Calixto Garcia. (COVID-19)
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center for Technological Applications and Nuclear Development (CEADEN)
Secondary sponsor:
University Hospital General Calixto Garcia
Source(s) of monetary or material support:
Center for Technological Applications and Nuclear Development (CEADEN), University Hospital General Calixto García, Ministery of Public Health
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Yanet
Last name:
Morejon Diaz
Medical Specialty :
First degree specialist in General Integral Medicine and First degree specialist in Hygiene and Epidemiology
Affiliation:
University Hospital General Calixto Garcia
Postal address:
University Avenue and J street. Revolution Square
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-78982171
Email address:
secdircg@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
19/03/2020
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
COVID-19
Health condition(s) code:
Disease Prevention
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Nidovirales Infections
Betacoronavirus
Health condition keyword:
COVID-19
SARS-CoV2
Intervention(s):
Group I, Curmeric. Natural product with Curcuma longa extracts- intellectual property under request-(oral) 4mL gargars/mouth wash after main meals for 1 month. Group II, No intervention In the study group (group I) was included the hospital workers more exposed to patients with respiratory diseases and, in the control group (group II) was included less exposed hospital workers
Intervention code:
Curcuma
Administration, Oral
Plant Extracts
Intervention keyword:
mouthwashes, gargles
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Patient confirmed with COVID-19 (Yes, No). Measurement time: 1 month
Key secondary outcomes:
Adverse Events-AE (Occurrence of AE (Yes, No); Type of event (name of AE); Intensity of AE (Mild, Moderate, Severe); Result (Recovered, Not recovered, Recovered with sequelae, Death); Required treatment (Yes, No)). Measurement time: 1 month
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
19 years
Maximum age:
85 years
Inclusion criteria:
Workers of the University Hospital General Calixto Garcia form the departments/services of first and second level of exposition to the patients with respiratory diseases and presencial work.
Exclusion criteria:
Known allergy to turmeric
Type of population:
Adults
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Observational
Purpose:
Prevention
Allocation:
Non-randomized controlled trial
Masking:
Open
Control group:
No intervention
Study design:
Parallel
Phase:
N/A
Target sample size:
199
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Tania
Last Name:
Valdes Gonzalez
Specialty:
Pharmautical Sciences, PhD
Affiliation:
Center for Technological Applications and Nuclear Development (CEADEN)
Postal Address:
30th street and 5th Av. Playa
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-72022566-09
Email :
taniajapon@gmail.com
taniavaldes@infomed.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Tania
Last Name:
Valdes Gonzalez
Specialty:
Pharmaceutical Sciences, PhD
Affiliation:
Center for Technological Applications and Nuclear Development (CEADEN)
Postal Address:
30th street and 5th Av. Playa
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-72022566-09
Email :
taniajapon@gmail.com
taniavaldes@infomed.sld.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
General Calixto Garcia University Hospital
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
16/03/2020
Postal address of Ethic Committee :
Avenue Universidad and street J. Revolution Square. Havana, ZC:10400, Cuba
Telephone:
+53-78382171
Email:
secdircg@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
199
Study completion date:
18/04/2020
Date of available results:
30/11/2020
Date of first publication:
31/12/2020
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000344
Date of Registration in Primary Registry:
24/11/2020
Record Verification Date:
2020/12/21
Next update date:
2021/12/21
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