CTRI/2018/02/011789
Completed
Phase 2
Clinical Evaluation for Thrombopoietic activity of PLATENZA Tablet in the Cases of Dengue with Thrombocytopenia, Randomized Open Label Comparative Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •1\. Subject diagnosed with DHF Grade 3 or 4, with hypotension / hypovolemia, subjects with platelet count \<30000/µL.
- •2\.subjects presenting with hemorrhagic phenomena at screening evidenced with positive torniquette test, petechiae, ecchymoses, or purpura, bleeding from the oral mucosa, gastrointestinal tract, injection sites or other locations and haemetemesis or melaena.
- •3\.subjects with dengue fever associated with any bleeding disorders or those taking blood thinning medications such as aspirin or warfarin.
- •4\.subjects with the history of any severe metabolic disorders.
- •5\.pregnant \& lactating women
- •6\.subjects not willing to sign informed consent form are excluded from the study.
Outcomes
Primary Outcomes
Not specified
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