Health Condition 1: B820- Intestinal helminthiasis, unspecified
Conditions
Interventions
None listed
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be an otherwise healthy child, based on medical history, physical examination, vital signs and concomitant medications 2. Participants with presence of intestinal helminths eggs in the stool 3. Participant must be available to return to the study site for all visits, including the follow-up visit 4. Parent(s) or guardians of participants (or their legally-accepted representatives) must be willing to sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study 5. Children 6 years of age and older will be asked to assent (agree) to their participation using appropriate language to their level of understanding; assent will be documented
Exclusion criteria
Exclusion criteria: 1. Participant has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at screening or at the time of randomization 2. Participant has a significant medical disorder, participant has difficulty in chewing or swallowing 3. Participant has clinically significant signs and symptoms of anaemia 4. Participant has significant wasting (greater than 2 standard deviations below the mean World Health Organization Child Growth Standards for weight-for-height or body mass index) 5. Participant has a known hypersensitivity to any ingredients of investigational product 6. Participant has preplanned surgery or procedures that would interfere with the conduct of the study during the course of study 7. Participant has taken any form of deworming medication within 30 days of entry into the study. 8. Any other condition due to which children are deemed to be unsuitable by investigator for reason(s) not specifically stated in the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in fecal egg count (ova and cyst counts of various helminths)Timepoint: Screening (Days up to 5), Baseline visit (Day 0), Follow up visit 1 (Day 15) and End of study visit (Day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parasitological cure rate 2. Change in clinical symptoms i.e. abdominal pain, diarrhea, abdominal fullness, flatulence, over all digestion, Sleep, satiety, fatigue, general energy levels and physical activity 3. Change in weight 4. Safety and tolerability through adverse event (AE) reporting, vital and clinical signs and symptoms Timepoint: Screening (Days up to 5), Baseline visit (Day 0), Follow up visit 1 (Day 15) and End of study visit (Day 30) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed