Efficacy and Safety of Carica Papaya Leaf Extract Syrup in Thrombocytopenia associated With Dengue Fever, in Paediatric Patients

Phase 4

Completed

• Conditions: Health Condition 1: null- Thrombocytopenia associated with Dengue fever in Paediatric Patients

• Registration Number: CTRI/2018/03/012792
• Lead Sponsor: Micro Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-23
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 285

Inclusion Criteria

1.Subjects who are confirmed to have DF or DHF grade I and II by NS1 antigen test

2.Subjects having thrombocytopenia with platelet count 30,000-1,00,000 /micro litre

3.Subjects with a baseline alanine transaminase (ALT) level of not more than 3 times of the upper limit of the normal range (not more than 165 U/L)

4.Subjects parent/ guardian who is willing to give informed consent to participate in study.

Exclusion Criteria

1. Subjects with Dengue hemorrhagic fever grade III and IV

2. Subjects with platelet count less than 30,000/micro litre

3. Subjects who have received blood or blood products transfusion during the current illness

4. Subjects with thrombocytopenia Purpura (ITP), Leukaemia, Haemophilia

5. Subjects who have a serum ALT level 3 times higher than the upper limit of the normal range ( >165 U/L)

6. Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females)

7. Participation in another trial with an investigational drug within 1 month prior to this trial.

8. Hypersensitivity to any of the components of the formulation

9. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in the platelet counts from the baseline levels to the end of therapyTimepoint: Day 1, Day 2, Day 3 Day 4 and Day 5

Secondary Outcome Measures

Name	Time	Method
Change in the RBC levels from the baseline levels till the end of therapyTimepoint: Baseline (Day 1 )Day 2, Day 3 Day 4 and Day 5 (End of Study);Change in WBC levels from the baseline levels till the end of therapyTimepoint: Baseline (Day 1 )Day 2, Day 3 Day 4 and Day 5 (End of Study);Tolerability and safety assessment based on adverse effects as mentioned by the parents and evaluated by the investigatorTimepoint: Baseline to end of the Study