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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000440

Enrollment

200

Registered

2024-05-09

Start date

2024-06-28

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giardiosis

Interventions

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

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

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

Countries

Cuba

Contacts

Public ContactAngel Escobedo Carbonell

Gastroenterology Institute

angel.escobedo@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026