Curmeric- Nasal-Safety-Efficacy- 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 and efficacy study of the natural product Curmeric-nasal in a quarantined community of 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:

Jorge

Last name:

Torres Concepcion

Medical Specialty :

Specialist of first grade Medicine General Integrative, MSc. Infectious diseases

Affiliation:

Polyclinic Lidia y Clodomira

Postal address:

Retoria corner Enlace. Municipality Regla

City:

Havana

Country:

Cuba

Zip Code:

11200

Telephone:

+53-77944441

Email address:

gmsregla@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:

21/10/2020

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 that contains extracts of Curcuma longa -in intellectual property process- (nasal) 2 nasal drops in each nostril 3 times a day for 1 month. The group I included, the blocks of the primary health care area identified as a COVID-19 focus. Group II, did not receive any product, includes the blocks of the same health area that were not classified as COVID-19 focus.

Intervention code:

Turmeric

Plant Extracts

Administration, Intranasal

Nasal Sprays

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):

Number of positive cases for COVID-19 (Number of positive subjects). Measurement time: A month after inclusion

Key secondary outcomes:

Adverse Events-AE (Occurrence of AE (Yes, No); Type of event (name of AE); Intensity of AE (light, Moderate, Severe); Outcome (Recovered, Not recovered, Recovered with sequelae, Fatal); Requires treatment (Yes/No)). Measurement time: A month after inclusion

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:

Inhabitants of the area 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:

Non-randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

148

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. Municipality 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 :

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:

148

Study completion date:

25/11/2020

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:

RPCEC00000352

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:

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Curmeric- Nasal-Safety-Efficacy- Community-Quarantine -COVID-19

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