Soft capsules with ozonated sunflower oil versus oral OLEOZON® in patients with Giardiosis

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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.

Acronym of Public Title:

AGO-G01

Scientific title:

Study of the efficacy, safety and tolerability of soft capsules with ozonated sunflower oil versus oral OLEOZON® in patients with Giardiosis

Acronym of Scientific Title:

AGO-GIA

Secondary indentifying numbers:

AGO-GIA01

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

Source(s) of monetary or material support:

Ministry of Science, Technology and Enviroment (CITMA)

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:

Angel

Midle name:

Arturo

Last name:

Escobedo Carbonell

Medical Specialty :

Second Degree Specialist in Dermatology

Affiliation:

Gastroenterology Institute

Postal address:

25 Street /H and I, Vedado, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-53863876

Email address:

angel.escobedo@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:

Pending

Date of first enrollment:

28/06/2024

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:

Giardiosis

Intervention(s):

Group 1 (Experimental): Soft capsules (1ml) with ozonated sunflower oil (a capsule by oral route 1 hour before breakfast and 3 hours after the last meal) during the first 10 days of treatment, resting for a week (7 days). Then the treatment will repeat for 10 more days, until completing 27 days. Group 2 (Control): Oral OLEOZON® (1ml) (20 drops orally 1 hour before breakfast and 3 hours after the last meal) during the first 10 days of treatment, resting for a week (7 days). Then the treatment will repeat for 10 more days, until completing 27 days.

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):

1. Clinical Cure (absence of gastrointestinal symptom) or clinical improvement (improvement of gastrointestinal symptoms). Measurement time: 10, 17 and, 27 days of treatment. 2. Microbiological Cure (Negativization of the parasite study). Measurement time: 10, 17 and, 27 days of treatment. 3. Clinical and Microbiological Healing (When both conditions are fulfilled). Measurement time: 10, 17 and, 27 days of treatment.

Key secondary outcomes:

Treatment time to achieve healing (Days from randomization until Clinical and Microbiological Healing). Measurement time: 10, 17 and 27 days of treatment

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:

None

Inclusion criteria:

Patients of both sexes, with 19 years or older, with gastrointestinal symptoms as diarrhea, pain in the upper abdomen, nausea, vomiting, weight loss, bloating or hivesand, a confirmatory diagnosis of Giardiosis who attend an outpatient clinic at the Institute of Gastroenterology and agree to participate in the study, written informed consent.

Exclusion criteria:

Patients with: 1. Other parasites 2. Anemia 3. Decompensated chronic diseases 4. Diagnosed neoplasms 5. Pregnant or lactating women 6. Hypersensitivity to the study drug

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

200

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:

Angel

Middle Name:

Arturo

Last Name:

Escobedo Carbonell

Specialty:

Second Degree Specialist in Microbiology

Affiliation:

Gastroenterology Institute

Postal Address:

25 street / H and I, Vedado, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-53863876

Email :

angel.escobedo@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:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Doctor in Pharmaceutical Sciences

Affiliation:

National Centre for Scientific Research (CNIC)

Postal Address:

25 Avenue and 158 Street, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Gastroenterology Institute

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

02/05/2024

Postal address of Ethic Committee :

Calle 25 entre H e I. Vedado, Plaza de la Revolucion, ZC: 10400, La Habana. Cuba

Telephone:

+53-78325067

Correo electrónico:

lissetglezf@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

25/10/2024

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:

RPCEC00000440

Date of Registration in Primary Registry:

09/05/2024

Record Verification Date:

2024/05/09

Next update date:

2025/05/09

Link to the spanish version:

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Soft capsules with ozonated sunflower oil versus oral OLEOZON® in patients with Giardiosis

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