Therapeutic clinical evaluation of the Plectranthus amboinicus Lour Spreng (Oregano French) tablets in patient with common cold

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:

Secondary indentifying numbers:

EC-00409

Issuing authority of the secondary identifying numbers:

Drug Research and Development Center (CIDEM)

Source(s) of monetary or material support:

Cuban Ministry of Public Health (MINSAP)

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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

06/12/2010

Reference number:

05.032.09-N

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Yolanda A. Rodriguez Cambara, MD. Integral General Medicine Specialist

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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

Research ethics committees:

Surgical Clinical Hospital “Dr Luis Diaz Soto”, July 23, 2009

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

15/03/2011

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:

Common cold

Intervention(s):

Group A (Control): Placebo + Symptomatic treatment Group B (Study): 300 mg of French oregano + Symptomatic treatment Group C (Study): 600 mg of French oregano + Symptomatic treatment The French oregan, the placebo and the Symptomatic treatment will be administered every 8 hours during 15 days by oral route.

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):

Frequency of the cough in 24 hours (0 - Non cough, 1 - of 1 to 4 times, 2 - of 5 to 10 times, 3 - of 11 at 15 times and 4 - more than 15 times). Measuring time: 3, 7 and 15 days. Intensity of the cough in 24 hours (Slight: less than 5 accesses of cough and it can accompany of expectoration. Moderate: More than 5 accesses of cough and less than 10. Severe: More than 10 accesses of cough). Measuring time: 3, 7 and 15 days. Expectoration presence. (Yes/No).Measuring time: 3, 7 and 15 days.

Key secondary outcomes:

Adverse events (Description, Intensity, Duration). Measuring time: 15 days. Description of the adverse event (Name) Intensity of the adverse event (Light, Moderate, Severe) Duration of the adverse event. (differs of date among the beginning and final of the event)

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

N/A (No limit)

Inclusion criteria:

1. Patient bigger than 18 years of age. 2. Written consent of patient 3. Patient with cough and expectoration of less than 14 days. 4. Negative Leucogram, with or without altered lymphocytes.

Exclusion criteria:

1. Pregnancy or breastfeeding. 2. Not meet any criteria for inclusion. 3. Patients with ERC Chronic disorders: Asthma, EPOC, bronquiectasias 4. Ingestion of medications: steroids, antipsicóticos habitually. 5. Ingestion of antibiotics, broncodilatadores, during one previous month. 6. Cough originated by adverse effect to the IECA or foreign bodies. 7. Patients with presence of sputum purulento, serous or bloody. 8. Patients with presence of humid stertors in the physical test. 9. Patients with decompensated Chronic disorders not transmissible. 10.Patients with any neurological or systemic disorder affecting the nervous system. 11.HIV.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1-2

Target sample size:

90

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:

Jorge

Last Name:

Rodriguez Chanfrau

Affiliation:

Drug Research and Development Center CIDEM)

Postal Address:

Ave 26 # 1605. Nuevo Vedado.

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

537-8811424

Email :

jorge.rodriguez@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:

Jorge

Last Name:

Rodriguez Chanfrau

Affiliation:

Drug Research and Development Center CIDEM)

Postal Address:

Ave 26 # 1605. Nuevo Vedado.

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

537-8811424

Email :

jorge.rodriguez@infomed.sld.cu

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:

RPCEC00000124

Date of Registration in Primary Registry:

2011-11-22

Record Verification Date:

2011-11-04 20:00

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Therapeutic clinical evaluation of the Plectranthus amboinicus Lour Spreng (Oregano French) tablets in patient with common cold

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