Soft capsules with ozonated sunflower oil versus oral OLEOZON® in patients with Giardiosis
Not Applicable
- Conditions
- Giardiosis
- Registration Number
- RPCEC00000440
- Lead Sponsor
- ational Centre for Scientific Research (CNIC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical Cure (absence of gastrointestinal symptom) or clinical improvement (improvement of gastrointestinal symptoms). Measurement time: 10, 17 and, 27 days of treatment.<br>2. Microbiological Cure (Negativization of the parasite study). Measurement time: 10, 17 and, 27 days of treatment.<br>3. Clinical and Microbiological Healing (When both conditions are fulfilled). Measurement time: 10, 17 and, 27 days of treatment.
- Secondary Outcome Measures
Name Time Method Treatment time to achieve healing (Days from randomization until Clinical and Microbiological Healing). Measurement time: 10, 17 and 27 days of treatment