| CTRI Number |
CTRI/2016/02/006638 [Registered on: 15/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
20/05/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the safety and efficacy of Peanut Safe Syringe |
|
Scientific Title of Study
|
A randomized, controlled single centre clinical study to asses the safety& efficacy of Peanut Safe Syringe against the conventional syringes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharathi Muniyappa |
| Designation |
Proffesor & HOD Dept. of Pathology |
| Affiliation |
Mysore Medical College & Research Institute. Contact No: 0821-4260778 |
| Address |
Mysore Medical College
Irwin Road
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
|
| Fax |
|
| Email |
govt.k.r.hospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Chand Jangid |
| Designation |
Senior Clinical Research Co-ordinator |
| Affiliation |
Mysore Medical College & Research Institute. Contact No: 0821-4260778 |
| Address |
Clinical Research Room, Next to PWD Office
K.R. Hospital ,Irwin Road,
Mysore-570001 (Karnataka) India
Mysore
KARNATAKA
57001
India |
| Phone |
|
| Fax |
|
| Email |
govt.k.r.hospital@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Chand Jangid |
| Designation |
Senior Clinical Research Co-ordinator |
| Affiliation |
Mysore Medical College & Research Institute. Contact No: 0821-4260778 |
| Address |
Clinical Research Room, Next to PWD Office
K.R. Hospital ,Irwin Road,
Mysore-570001 (Karnataka) India
Mysore
KARNATAKA
57001
India |
| Phone |
|
| Fax |
|
| Email |
govt.k.r.hospital@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MERADAS |
| Address |
Syamala Building,
Pantheerankavu ( P.O),
Kozhikode-19, |
| Type of Sponsor |
Other [Manufacturer] |
|
|
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 |
| Dr Bharathi Muniyappa |
Mysore Medical College |
Irwin Road
Mysore
Karnataka
Mysore
KARNATAKA |
9900397241
govt.k.r.hospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee,Mysore Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects of age between 18 to 50.
For whom the Investigator considers that the compliance will be correct.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Disposable Syringe |
Conventional disposable syringe available in the market |
| Intervention |
Peanut Safe syringe |
Investigational Product |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a Subjects of age between 18 to 50.
b For whom the Investigator considers that the compliance will be correct.
c Cooperating, informed of the need and duration of the study, and ready to comply with protocol procedures.
d Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
|
|
| ExclusionCriteria |
| Details |
a. Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
b. Known sensitivity to the investigational product.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the efficacy of Peanut safe syringe |
Visit 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the safety of Peanut safe syringe |
Visit 3 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/10/2015 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publication are made yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is ‘A randomized,
controlled, single centre clinical study to assess the safety &
efficacy of Peanut Safe Syringe against the conventional syringes.’ Two groups will
be randomized for this study. One group will be using Peanut safe syringe and
another group will be using conventional syringe.In this study we will be
assessing the safety & efficacy of Peanut safe syringe with
the help of questionnaires & QOL given to subjects and healthcare
professionals separately.
- Primary
Objective- To
find out the efficacy of Peanut safe syringe, when compared
with the conventional syringe available in the market
- Secondary objective: To assess the safety of Peanut
safe syringe, , when compared with the conventional syringe available
in the market
Preclinical
experience: A preclinical study
to assess the pain and behavioural changes in animals while using the
investigational product were done in rabbits at the animal test facility at
Radiant Research, Bangalore. The pain, behavioral and dermal activity in
rabbits were observed and scored by the investigational product in
comparison with the control product (market product). Pain and behavioral
scoring was done on the use of investigational product, whereas, dermal
activity was observed for 24 hour from the time of investigational product use. The investigational
product, on usage didn’t cause any additional pain and behavioural changes in
rabbits in comparison with control group It was observed that, it
didn’t caused any additional dermal activity post usage up to 24 hrs. Clinical Trial Result This study was designed to explore the
safety, tolerability, and efficacy of Peanut Safe syringe. Two hundred (200) adult subjects were
enrolled in the study and were randomize in two groups: Test & Control. All
the subjects completed all the visits. It can be concluded from this study
that Peanut safe syringe is efficacious to be used in human subjects
, Analysis of safety parameters shows that investigational
product is not altering or causing any symptomatic reactions in subject’s safety
variable. It was found that Peanut safe
syringe is safe for using in human subjects.
|