| CTRI Number |
CTRI/2018/07/014988 [Registered on: 20/07/2018] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial for A life saving measure for Dengue patients :Carica Papaya Leaf Extract |
|
Scientific Title of Study
|
A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, (ZYBORICA TABLET ) as empirical therapy for thrombocytopenia associated with dengue fever |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr LAKSHMANA PERUMAL SPT |
| Designation |
Managing Director |
| Affiliation |
Mi Lab LifeSciences(P) Limited |
| Address |
Mi Lab LifeSciences(P) Limited
81 & 82, Shree Om Ramaswamy Reddy Layout, Horamavu, Bengaluru, Karnataka
Bangalore
KARNATAKA
560043
India |
| Phone |
8050717400 |
| Fax |
|
| Email |
lakshman@milablifesciences.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr LAKSHMANA PERUMAL SPT |
| Designation |
Managing Director |
| Affiliation |
Mi Lab LifeSciences(P) Limited |
| Address |
Mi Lab LifeSciences(P) Limited
81 & 82, Shree Om Ramaswamy Reddy Layout, Horamavu, Bengaluru, Karnataka
Bangalore
KARNATAKA
560043
India |
| Phone |
8050717400 |
| Fax |
|
| Email |
lakshman@milablifesciences.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr LAKSHMANA PERUMAL SPT |
| Designation |
Managing Director |
| Affiliation |
Mi Lab LifeSciences(P) Limited |
| Address |
Mi Lab LifeSciences(P) Limited
81 & 82, Shree Om Ramaswamy Reddy Layout, Horamavu, Bengaluru, Karnataka
Bangalore
KARNATAKA
560043
India |
| Phone |
8050717400 |
| Fax |
|
| Email |
lakshman@milablifesciences.com |
|
|
Source of Monetary or Material Support
|
| Mi Lab LifeSciences(P) Limited
81 & 82, Shree Om Ramaswamy Reddy Layout, Horamavu, Bengaluru, Karnataka 560043 |
|
|
Primary Sponsor
|
| Name |
Mi Lab LifeSciencesP Limited |
| Address |
81 & 82, Shree Om Ramaswamy Reddy Layout, Horamavu, Bengaluru, Karnataka 560043 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShivaraj KK |
Pristine Hospital & Research Centre Pvt Ltd |
877,1st Floor Room No 2 Dr MC Modi Hospital Rd, K. N. Extension, West of Chord Road, Stage 2, Nagapura, Bengaluru, Karnataka 560086
Bangalore
KARNATAKA |
9035209089
shivarajkk09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Pristine Hospital & Research Centre Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carica Papaya Leaf Extract, (ZYBORICA TABLET) 1100mg |
dose :1100mg
frequency: 3 times per day after food
route of administration : Oral |
| Comparator Agent |
Placebo containing starch 1100mg |
dose :1100mg
frequency: 3 times per day after food
route of administration : Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients above 18 years and below 60 years old,
2. Patients who are confirmed to have DF or DHF grade I and II by NS1 antigen test,
3. Patients having thrombocytopenia with at platelet count between 30,000 /micro litre to 150,000/micro litre,
4. Patients 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),
5. Patient who is willing to give informed consent to participate in study
|
|
| ExclusionCriteria |
| Details |
1. Patients with Dengue hemorrhagic fever grade III and IV,
2. Patients with platelet count less than 30,000/micro litre,
3. Pregnant or lactating women,
4. Patients who have received blood or blood products transfusion during the current illness,
5. Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia,
6. Patients who have a serum ALT level 3 times higher than the upper limit of the normal range (>165 U/L),
7. Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females)
8. Participation in another trial with an investigational drug within 1 month prior to this trial.
9. Hypersensitivity to any of the components of the formulation,
10. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in the platelet counts from the baseline
levels to the end of therapy |
Day 1,Day 2,Day 3,Day 4 and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the RBC levels from the baseline
levels till the end of therapy
Change in WBC levels from the baseline levels
till the end of therapy
Change in the Haematocrit levels from the
baseline levels to the end of therapy
Comparison of incidence and rate of adverse
events occurred between the two arms to
evaluate the safety and tolerability.
|
Day 1,Day 2,Day 3,Day 4 and Day 5 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/07/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Carica papayaleaf extract has attracted attentions because of the promising results shown from the various studies conducted in South East Asian countries on the effectiveness of carica papayaleaf extract on increasing the platelet counts in patients with thrombocytopenia associated with Dengue. This trial is designed as Multi-centric, double blind, placebo controlled, Randomized, Prospective study in patients aged 18 years and above and having thrombocytopenia associated with dengue fever |