Health Condition 1: K639- Disease of intestine, unspecified
Conditions
Interventions
Intervention1: Suspension Albendazole 400 mg and Ivermectin 3 mg/6mg/12 mg: Single Dose Suspension Albendazole 400 mg and Ivermectin 3 mg/6mg/12 mg
Single dose administered at randomization visit
Con
Sponsors
MANKIND PHARMA LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children in the age group of 6-15 years attending the schools selected for the study. 2. Parents willing to provide written informed consent to participate in the trial and assent from children aged 7 and above.
Exclusion criteria
Exclusion criteria: 1. Presence of any major severe systemic illness, chronic severe anaemia 2. History of epileptic disorders, visual disturbances, chronic headache 3. Current use of anti-epileptics 4. Any subject febrile on the day of enrolment 5. Presence of any acute illness, vomiting, headache etc. on the day of enrolment 6. Recent use of anti-helmintic drugs through governmentâ??s mass drug administration program within the past 3 months in both the study subject and any household contacts 7. Known allergy to the study medications 8. Current use of drugs known to have pharmacological interaction with Albendazole or Ivermectin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the efficacy of Albendazole and Ivermectin combination Vs Albendazole in reduction of Soil Transmitted Helminth infections measured as Microbiological Cure Rate between the two arms.Timepoint: Baseline (D0) to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate and compare the egg reduction rate against STH infections between both arms from baseline to study end. 2. To evaluate and compare clinical cure rate from baseline to study end between both arms calculated as the percent of subjects at study end who are free from symptoms of infestation presented at baseline post treatment. 3. To evaluate the prevalence of stool positivity for STH in a given geographical areaTimepoint: 1.The number and proportion of subjects with an egg reduction rate against the STHs calculated as change in mean eggs per gram from baseline to treatment end. 2.Number and proportion of children with clinical cure at end of study visit of Day 7 defined as the disappearance of clinical signs and symptoms observed at baseline suggestive of infestation. 3.Number and Proportion of subjects with stool positivity for STH in a given geographical area. | — |
Countries
India
Contacts
Public ContactDr Rajat Singhal
Mankind Pharma
Outcome results
None listed