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Clinical Trials/CTRI/2018/03/012738
CTRI/2018/03/012738CompletedPhase 2

Clinical Evaluation for the Thrombopoietic Activity of Platenza Tablet in Cases of Dengue with Thrombocytopenia- Randomized Open Label Controlled Comparative Clinical Study

The Himalaya Drug Company0 sites60 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1. Both male and female subjects between the age group of >=18 years to <= 60years who are confirmed to have DF (Dengue Fever) grade 1 and grade 2 by IgG, IgM and NS1 Antigen.
  • •2.Subjects who have been diagnosed with clinically significant dengue fever associated with thrombocytopenia with platelet count between 30000/µL to 1,00,000/µL.
  • •3.Subjects with the SGPT level not more than 2 times the upper limit of normal.
  • •4.Subjects with stable vitals like pulse and blood pressure
  • •5.Subjects willing to give written informed consent
  • •6.Subjects who had not participated in similar kind of study in last 3 months were included into the study.

Exclusion Criteria

  • •Subject diagnosed with DHF Grade 3 or 4.
  • •Subjects with hypotension / hypovolemia.
  • •Subjects platelet count <30000/µL.
  • •Subject presenting with hemorrhagic phenomena at screening evidenced with positive Torniquette test, petechiae, ecchymoses, or purpura, bleeding from the mucosa, gastrointestinal tract, injection sites or other locations and haemetemesis or melaena are excluded from the study.
  • •Bleeding disorders or those taking blood thinning medications such as aspirin or warfarin.
  • •Subjects with the history of diabetes mellitus treated with any Oral Hypoglycaemic Agents.
  • •Subjects with the history of clinically significant cardiovascular condition treated with the medication Amiodarone
  • •Subjects with infectious condition treated with antibiotics like penicillin G , ampicillin, amoxyclav, cephalothin,polymyxin B, rifampicin, amikacin, nalidixic acid, gentamycin, cholarmphenicol, oflxacin.
  • •Subjects with established hematological disorders including idiopathic thrombocytopenia purpura, leukemia, hemophilia.
  • •Has received blood products or blood transfusion during the current hospital stay Or during last one month
  • •Hypersensitive to any of the ingredients.
  • •Use of prescription medication to treat gastric problems
  • •Pregnant & lactating women.
  • •Not willing to sign informed consent form

Investigators

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Platenza Tablets for Dengue fever | Clinical Trial