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CTRI Number  CTRI/2020/01/022785 [Registered on: 15/01/2020] Trial Registered Prospectively
Last Modified On: 14/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Syrup for dengue fever in Children  
Scientific Title of Study   An Open Label, Single Arm Clinical study To Evaluate The Safety and Efficacy of HPLT031707 SYRUP in Cases of Thrombocytopenia Associated With Dengue Fever in Pediatric Population 
Trial Acronym  PL_S 
Secondary IDs if Any  
Secondary ID  Identifier 
HDC/CP/PP/018/2019 Version 1.0 Date 30 SEP 2019   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrikiran A 
Designation  Professor and HOD 
Affiliation  Kasturba Hospital  
Address  Department of Paeditrics KMC Manipal Manipal University

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  shrikiran.a@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Palaniyamma 
Designation  Medical Advisor 
Affiliation  The Himalaya Drug Company 
Address  Room 301, 3rd Floor Clinical Phramacacology Reserach and Development Makali,Tumkur Road, Bangalore

Bangalore
KARNATAKA
562162
India 
Phone    
Fax    
Email  dr.palani@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Palaniyamma 
Designation  Medical Advisor 
Affiliation  The Himalaya Drug Company 
Address  Room no 301, 3rd Floor Clinical Phramacology Reserach and Development Makali, Tumkur Road, Bangalore

Bangalore
KARNATAKA
562162
India 
Phone    
Fax    
Email  dr.palani@himalayawellness.com  
 
Source of Monetary or Material Support  
The Himalaya Drug Company Makali, Tumkur Road, Bangalore-562162 
 
Primary Sponsor  
Name  The Himalaya Drug Company 
Address  The Himalaya Drug Company Makali, Tumkur Road, Bangalore 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrikairan  Kasturba Hospital Manipal   Research Room Ground floor Centre for Integrative Medicine & Research and Kasturba Hospital Manipal Academay of Higher Education Manipal -576104
Udupi
KARNATAKA 		 9448177671

shrikiran.a@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHE Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A90||Dengue fever [classical dengue],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HPLT031707 Syrup   Dose as per kg body weight of the children between 2 to 12 years mentioned below WEIGHT (Kgs) DOSE (mL) [Twice daily] 10-12 3 mL 13-15 4 mL 16-19 5 mL 20-22 6 mL 23-26 7 ml 27-29 8 mL 30-33 9 mL 34-37 10 mL 38-40 11 mL 41-43 12 mL 44-45 13 mL Route of Administration: Orally Duration: 7 days or who achieves the target platelet counts of 1.5 Lakh cells/mm3, which ever eralier  
Comparator Agent  No Comparator  No Comparator 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Increase in platelet counts as compared to day 0 to day 7.  7 days  
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken to achieve a platelet count of 1.5 Lakh cells/mm3
2. Improvement in hematocrit value
3. Restoration of SGPT within normal levels.
4. Overall compliance of the subject to the study medication
5. To assess any adverse events reported or observed during the study period. 		 7 days  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/01/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.
 
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