Safety and Efficacy of Mirazid for Schistosomiasis Treatment
Condition: Schistosoma Hematobium Infection; Schistosomiasis Mansoni
MeSH terms: Schistosomiasis; Schistosomiasis mansoni; Schistosomiasis haematobia
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical Trial Phase:Phase III

      Primary Objectives:

        -  Compare Mirazid and Praziquantel cure rates for both Schistosoma species.

        -  Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both
           Schistosoma species.

      Secondary Objective:Identify and compare the types and severity of side and adverse effects
      between the Mirazid and Praziquantel.

      Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged
      from 15-35 years. Those subjects will be selected from among those screened.Subjects will
      include both genders excluding chronically ill such as chronic liver disease patients and
      those with both types of Schistosomiasis.

      Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months
      for statistical analysis and report writing Study Duration: Total study duration is expected
      to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data
      management and report writing.

      Endpoints: Will be measured at 3 months of successful administration of treatment either
      Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the
      response to treatment will be done by examining urine or stool of the subject for presence of
      Schistosoma eggs and its density if found.

      Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will
      indicate treatment success. One positive sample collected at week 12 will indicate infection
      with Schistosomiasis.
    

Detailed description: 
      Study Design:This is a phase III, open-label randomized non-placebo-controlled Study in which
      the investigators will compare the efficacy and safety of Mirazid to Praziquantel as a
      treatment for Schistosomiasis. After screening, positive subjects for one of the
      Schistosomiasis will be recruited in the study. They will be treated by Mirazid as 600 mg
      oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as
      a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of
      treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis
      including egg counts for the positive cases.
    

Intervention name(s): Myrrh
Intervention type(s): Drug
Intervention description(s): Subjects will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases.
Other intervention name(s): Mirazid; Praziquantel; Shistosomiasis; Oral
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosomiasis hematobium; Schistosomiasis mansoni