A clinical trial to study the safety and efficacy of Peanut Safe Syringe
- Conditions
- Subjects of age between 18 to 50.For whom the Investigator considers that the compliance will be correct.
- Registration Number
- CTRI/2016/02/006638
- Lead Sponsor
- MERADAS
- Brief Summary
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 willbe randomized for this study. One group will be using Peanut safe syringe andanother group will be using conventional syringe.In this study we will beassessing the safety & efficacy of **Peanut safe syringe** withthe help of questionnaires & QOL given to subjects and healthcareprofessionals 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
**Preclinicalexperience:**
A preclinical studyto assess the pain and behavioural changes in animals while using theinvestigational product were done in rabbits at the animal test facility atRadiant Research, Bangalore. The pain, behavioral and dermal activity inrabbits were observed and scored by the investigational product incomparison with the control product (market product). Pain and behavioralscoring was done on the use of investigational product, whereas, dermalactivity was observed for 24 hour from the time of investigational product use.
The investigationalproduct, on usage didn’t cause any additional pain and behavioural changes inrabbits in comparison with control group It was observed that, itdidn’t caused any additional dermal activity post usage up to 24 hrs.
**Clinical Trial Result**
This study was designed to explore thesafety, tolerability, and efficacy of Peanut Safe syringe.
Two hundred (200) adult subjects wereenrolled in the study and were randomize in two groups: Test & Control. Allthe subjects completed all the visits.
It can be concluded from this studythat Peanut safe syringe is efficacious to be used in human subjects,
Analysis of safety parameters shows that investigationalproduct is not altering or causing any symptomatic reactions in subject’s safetyvariable.
It was found that Peanut safesyringe is safe for using in human subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- aSubjects of age between 18 to 50.
- bFor whom the Investigator considers that the compliance will be correct.
- cCooperating, informed of the need and duration of the study, and ready to comply with protocol procedures.
- dHaving signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
- a.Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
- b.Known sensitivity to the investigational product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To find out the efficacy of Peanut safe syringe Visit 3
- Secondary Outcome Measures
Name Time Method To find the safety of Peanut safe syringe Visit 3
Trial Locations
- Locations (1)
Mysore Medical College
🇮🇳Mysore, KARNATAKA, India
Mysore Medical College🇮🇳Mysore, KARNATAKA, IndiaDr Bharathi MuniyappaPrincipal investigator9900397241govt.k.r.hospital@gmail.com