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TO EVALUATE EFFICACY AND SAFETY OF DNT -53 IN PATIENTS WITH LOW PLATELET COUNT.

AN OPEN LABEL, MULTICENTER, CONTROLLED CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF DNT -53 IN PATIENTS WITH LOW PLATELET COUNT.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003919
Enrollment
72
Registered
2013-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D694- Other primary thrombocytopenia

Interventions

Intervention1: DNT53: DNT53 UP TO 07 DAYS - FOUR TIMES A DAY ORALLY 08 DAY-THREE TIMES A DAY ORALLY 09 DAY-TWO TIMES A DAY ORALLY 10 DAY-ONE TIME A DAY ORALLY-Group A-Alcoholic & Spleen Disorders - 1

Sponsors

OmMedi PharmaceuticalsPvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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).

Design outcomes

Primary

MeasureTime frame
â?¢ Increase in the Platelet count after the drug intervention Efficacy of the drug at day 0,3,5,7,9,11,13,28 and 56 Timepoint: at day 0,3,5,7,9,11,13,28 and 56—

Secondary

MeasureTime frame
â?¢ Any changes observed in the Platelet count level. Safety concern of the drug. Timepoint: At day 0,3,5,7,9,11,13,28 and 56—

Countries

India

Contacts

Public ContactDr Harisha S

harish@icbiocro.com

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026