Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea
NCT03598010 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2019-06-04
Summary
Evaluation of the efficacy of a treatment with Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile) in a pediatric population of children affected by acture/prolonged/chronic diarrhea
Conditions
- Diarrhea
- Chronic Diarrhea
- Acute Diarrhea
- Diarrhea, Infantile
Interventions
- DEVICE
-
Actitan-F (7dd)
1 sack every 4 hours, maximum 4 sacks/day for 7 days.
- DEVICE
-
Actitan-F (28dd)
1 sack every 4 hours, maximum 4 sacks/day for 28 days.
Sponsors & Collaborators
-
Aboca Spa Societa' Agricola
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-31
- Primary Completion
- 2020-12-31
- Completion
- 2021-03-31
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