Syrup for dengue fever in Children

Phase 2

Not yet recruiting

• Conditions: Dengue fever [classical dengue],

• Registration Number: CTRI/2020/01/022785
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

This is an open label, single arm, clinical study, with total 53 pediatric subjects subjected for screening and enrollment where only 44 eligible pediatric subjects who fulfill the inclusion criteria will be considered for statistical evaluation. 44 eligible subjects will be initiated with the study medication and shall be advised to take HPLT031707 syrup twice daily oral as per the child weight for a period of maximum of 7 days or till the subject achieves the target platelet count of 1.5 Lakh cells/mm3- whichever is earlier.

Subjects will be initiated for the informed consent process and then screening will be carried out for eligibility check and will be considered for enrollment into the trial group to receive HPLT031707 SYRUP at recommended dose  for a period of maximum of 7 days. Or till the subject achieve the target platelet counts of 1.5 Lakh cells/mm3 whichever is earlier. Clinical and laboratory assessments will be carried out from screening, day1, day 2, day 3, day 4. day 5, day 6 and day 7 [EOS]. This study is divided into Screening period, Active Treatment period and End of Study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-14
• Study Start: 2020-01-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 1)Both male and female pediatric subjects between the age group between ≥2 years to ≤12 years 2)Pediatric subjects already confirmed to have DF (Dengue Fever) through ELISA based NS1 Antigen test and/or IgM.
• 3)Pediatric subjects who have been clinically diagnosed with dengue fever associated with thrombocytopenia vis a vis platelet count between 50000 cells/mm3 to 1,00,000 cells/mm3.
• 4)Pediatric subjects with the SGPT level not more than twice the upper limit of the normal 5)Parents/Guardians/Caregiver related to pediatric subject willing to give written informed consent for his/her participation to the study 6)Pediatric subject aged > 7 years of age willing to sign the assent form for his/her participation in the study 7)Pediatric subjects who have not participated in this kind of trial in the past 4 weeks.

Exclusion Criteria

• 1)Pediatric subjects diagnosed with DHF Grade 3 or 4,with hypotension / hypovolemia and dehydration 2)Pediatric subjects with platelet count < 50000 cells/mm3 3)Pediatric subjects weighing <10 Kgs and >45 Kgs 4)Pediatric subjects with any febrile condition with temperature ≥103 degree ofF and with a history of any febrile seizures.
• 5)Pediatric subjects presenting with hemorrhagic phenomena at Day 1 (screening/baseline) evidenced with petechiae, ecchymoses, or purpura, bleeding from the oral mucosa, gastrointestinal tract (hemetemesis or melaena.), injection sites or other locations.
• 7)Pediatric subjects with the history of juvenile diabetes mellitus treated with medication.
• 8)Pediatric subjects with the history of clinically significant cardiovascular condition treated with medication 9)Pediatric subjects with history of UTI or acute or chronic infectious condition and on any antibiotics like polymyxin B, rifampicin, amikacin, nalidixic acid, gentamycin, cholarmphenicol, oflaxacin 10)Pediatric subjects with a history of established hematological disorders including idiopathic thrombocytopenia purpura, leukemia, hemophilia 11)Pediatric subjects who have received blood products or blood/platelet transfusion during the current hospital stay or during last one month 12)Pediatric subjects who are hypersensitive to any of the ingredients of the study medication 13)Pediatric subjects with a history of clinically significant systemic condition treated with aspirin or corticosteroids or heparin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in platelet counts as compared to day 0 to day 7.	7 days

Secondary Outcome Measures

Name	Time	Method
1. Time taken to achieve a platelet count of 1.5 Lakh cells/mm3	2. Improvement in hematocrit value

Trial Locations

Locations (1)

Kasturba Hospital Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital Manipal

🇮🇳Udupi, KARNATAKA, India

Dr Shrikairan

Principal investigator

9448177671

shrikiran.a@manipal.edu