Revisions for Curmeric- Safety-Community-Quarantine-COVID-19 | Registro Público Cubano de Ensayos Clínicos

--- 22 January 2021 - 2:44pm by Gladys
+++ 24 March 2023 - 7:18am by Gladys
+Disease Prevention
+Coronavirus Infections
+SARS Virus
+Coronaviridae Infections
+Nidovirales Infections
+Betacoronavirus
+COVID-19
+SARS-CoV2
+Curcuma
+Administration, Oral
+Plant Extracts
+mouthwashes,
+  gargles
-/01/22
+/01/25
-/01/22
+/01/25

Revision of 24 March 2023 - 7:18am:

Curmeric- Safety-Community-Quarantine-COVID-19

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:

Safety study of the natural product Curmeric in a quarantined community in primary care due to possible cases of COVID-19.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for Technological Applications and Nuclear Development (CEADEN) University Hospital General Calixto Garcia, Ministry 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:

Leticia

Last name:

Borrero Torres

Medical Specialty :

Specialist I grade Medicine General Integrative

Affiliation:

Polyclinic Rampa

Postal address:

Street 17th number 261 between entre J and I. Vedado. Revolution Square Municipality.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78352724

Email address:

prampa@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:

21/09/2020

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):

Curmeric. Natural product that contains extracts of Curcuma longa -in intellectual property process- (oral) 4mL gargle / mouthwash after the main meals for 1 month.

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):

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

Key secondary outcomes:

Not applicable

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

5 years

Maximum age:

85 years

Inclusion criteria:

All the inhabitants of the building in quarantine because of COVID-19 in primary health care.

Exclusion criteria:

Known allergy to Turmeric.

Type of population:

Children/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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

186

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:

Pharmaceutical Sciences, PhD

Affiliation:

Center for Technological Applications and Nuclear Development (CEADEN)

Postal Address:

Street 30th and 5ta Avenue. Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72021518

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:

Street 30th and 5ta avenue. Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72021518

Email :

taniajapon@gmail.com

taniavaldes@infomed.sld.cu

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:

02/09/2020

Postal address of Ethic Committee :

Ave. Universidad and street J. Plaza de la Revolución. Havana. C.P: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:

186

Study completion date:

21/10/2020

Date of available results:

01/03/2021

Date of first publication:

01/04/2021

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:

RPCEC00000350

Date of Registration in Primary Registry:

22/01/2021

Record Verification Date:

2021/01/25

Next update date:

2022/01/25

Link to the spanish version:

Click here

Registered Trials

Registration process

Curmeric- Safety-Community-Quarantine-COVID-19

About the RPCEC

Useful resources