TO EVALUATE EFFICACY AND SAFETY OF DNT -53 IN PATIENTS WITH LOW PLATELET COUNT.
- Conditions
- Health Condition 1: D694- Other primary thrombocytopenia
- Registration Number
- CTRI/2013/08/003919
- Lead Sponsor
- OmMedi PharmaceuticalsPvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
•Patients with the age group of 18 to 60 Years
•Willing to Sign on informed consent accordance with GCP and local legislation
•Patients with low Platelet count (Lower Limit- Greater than or equal to 80,000 per micro liter).
•Patient suffering from severe infectious disease in which the platelet count is generally lower.
•Patient suffering with diseases like Malaria, Vitamin B12 (or) folate deficiency, certain viral & bacterial infections, in which the platelet count is below normal range.
•Patient not willing to comply with the study procedure.
•Patients having the platelet count less than 80,000 per micro liter.
•Pregnant or Lactating women
•Other serious medical illness likely to interfere with study participation
•Significant psychiatric illness, senility, dementia or substance abuse
•Drug abuse within the 3 months prior to informed consent that would interfere with trial participation
•Participation in another trial within 3 months prior to informed consent
•Dehydration by clinical judgment of the investigator
•Any contraindication to blood sampling.
•Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
•Severe asthma that is poorly controlled with medication.
•HIV Positive serology.
•Certain medications that may interfere with the study medication (these will be identified by the study Investigator).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Increase in the Platelet count after the drug intervention <br/ ><br>Efficacy of the drug at day 0,3,5,7,9,11,13,28 and 56 <br/ ><br>Timepoint: <br/ ><br>at day 0,3,5,7,9,11,13,28 and 56
- Secondary Outcome Measures
Name Time Method â?¢Any changes observed in the Platelet count level. <br/ ><br>Safety concern of the drug. <br/ ><br>Timepoint: At day 0,3,5,7,9,11,13,28 and 56