| CTRI Number |
CTRI/2020/11/029254 [Registered on: 19/11/2020] Trial Registered Prospectively |
| Last Modified On: |
07/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Role of HPLT031707 SYRUP in low platelet count among children due to varied etiology. |
Scientific Title of Study
Modification(s)
|
An Open Label, Single Arm, Pilot Clinical study To Evaluate The Efficacy and Safety of HPLT031707 SYRUP in Cases of Thrombocytopenia due to varied etiology in Pediatric Population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/053/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balamma Sujatha |
| Designation |
Consultant Pediatrician |
| Affiliation |
Sankreswari Clinic, |
| Address |
Room No 1
9/4 IAF road,
Bharathiyar Nagar,
Pattabiram,
Thiruvallur
TAMIL NADU
600 072
India |
| Phone |
9840632574 |
| Fax |
|
| Email |
suja1973@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Srikrishna H A |
| Designation |
Research Scientist-Scientific Strategy & Medical writing |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No 301,3rd Floor Clinical Phramacology. Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
08067547230 |
| Fax |
|
| Email |
dr.srikrishna@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Clinical Trial Manager |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No 301,3rd Floor Clinical Phramacology. Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company. Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162 |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company. Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balamma Sujatha |
Sankreswari Clinic |
9/4 IAF Road
Bharathiyar nagar
pattibiram
chennai 600072
Thiruvallur
TAMIL NADU |
9840632574
suja1973@gmail.com |
| Dr Veerabhadra V Mallad |
SARV Advanced Multispecialty Clinic and Diagnostic Centre |
SLV Complex, Dasarahalli main Road,
Malleshpalya, New Tippasandra,
Bangalore-560075
Bangalore
KARNATAKA |
9742240815
drmallads@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| Universal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
HPLT031707 SYRUP will be administered at the recommended dose as per the weight and age of the pediatric subjects.
Route of administration : Oral
Frequency : Twice daily
Duration : Maximum 7 days
Dosage : as per subject age and weight.
|
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| 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 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 – 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in platelet counts as compared to baseline |
Day-1 to Day-7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken to achieve a platelet count of 1.5 Lakh cells/mm3
2. Overall compliance of the subject to the study medication
3. To assess any adverse events reported or observed during the study period. |
Day-1 to Day-7 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2020 |
| 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
|
Nil |