Role of HPLT031707 SYRUP in low platelet count among children due to varied etiology.

Phase 2

• Conditions: Health Condition 1: A90- Dengue fever [classical dengue]

• Registration Number: CTRI/2020/11/029254
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Both male and female pediatric subjects between the age group of >=2 years to <= 12 years

2. Paediatric subjects who are diagnosed with thrombocytopenia (platelet count between 50000 cells/mm3 to 1 Lakh cells/mm3) due to any of the following conditions:

i Infection conditions which are associated with mild to moderate thrombocytopenia viz., associated with dengue fever, malaria, typhoid

ii Any other chronic conditions which require transient increase in platelet counts (like injection, tooth extract or injury) to avoid any possible bleeding).

• Acute Immune thrombocytopenic purpura (ITP)

• Post-Viral infections/ Post Immunization such as Hepatitis C, B, H1N1 and MMR.

iii Exposure to certain medications or toxins: Other than drugs/ toxins causing drug-induced hypoplasia of the bone marrow

• Sedatives and anticonvulsant agents (carbamazepine, phenytoin, valproic acid)

• Analgesic agents (acetaminophen, diclofenac, naproxen)

• Diuretic agents â?? chlorothiazide

• Heparins (Unfractionated heparin, low-molecular-weight heparin)

• Cinchona alkaloids (quinine, quinidine)

• Platelet inhibitors (abciximab, eptifibatide, tirofiban)

• Antirheumatic agents (Gold salts, D-penicillamine)

• Antimicrobial agents (linezolid, rifampin, sulfonamides, vancomycin)

• Histamine-receptor antagonists - cimetidine

3. Parents/Guardians/Caregiver related to paediatric subject willing to give written informed consent for his/her child to participate in the study

4. Paediatric subject aged > 7 years of age willing to provide oral assent for his/her participation in the study.

5. Paediatric subjects who have not participated in this kind of trial in the past 4 weeks.

Exclusion Criteria

1. Paediatric subjects with platelet count <50000/μL or more than 1 Lakh cells/mm3.

2. Paediatric subjects weighing <10 Kgs and >45Kgs.

3. Paediatric subjects with any febrile condition with temperature >103 0F and with a history of any febrile seizures

4. Paediatric subjects presenting with haemorrhagic phenomena at Day 1 (screening/baseline) e.g. evidence of petechiae, ecchymoses, bleeding from the oral mucosa, gastrointestinal tract (hematemesis or melaena.), injection sites or other locations.

5. Paediatric subjects diagnosed with any haemorrhagic phenomenon or shock as assessed by hypotension, hypovolemia and dehydration

6. Paediatric subjects with the history of juvenile diabetes mellitus treated with medication.

7. Paediatric subjects with a history of established hematological disorders including leukemia and hemophilia.

8. Paediatric subjects with a history of established malignancy, which requires cytotoxic chemotherapy.

9. Paediatric subjects who have received blood products or blood/platelet transfusion within one month of screening.

10. Paediatric subjects who are hypersensitive to any of the ingredients of the study medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in platelet counts as compared to baselineTimepoint: Day-1 to Day-7

Secondary Outcome Measures

Name	Time	Method
1. Time taken to achieve a platelet count of 1.5 Lakh cells/mm3 <br/ ><br>2. Overall compliance of the subject to the study medication <br/ ><br>3. To assess any adverse events reported or observed during the study period.Timepoint: Day-1 to Day-7