National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Design and evaluation of an intranasal nanoformulation for conjugated linoleic acid for the treatment of pentylenetetrazole (PTZ) induced seizures in mice

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

The protocol needs modifications:

Comment to the Committee

The protocol needs modifications:

1- The study period is one week!!!!

2- The funding was not specified (it says "self-funding").
3- Researcher number 2 in the protocol is named Mona Mohamed Agwa Affiliation.
4- In the experimental design section, it is unclear how group 4 will be treated (the study will consist of 6 groups).
5- The sample size and groups section was duplicated in the experimental design section.

6- In the section "How to explain how you calculated the sample size," a reference to the same group on Nanospri was included.
7- The Gantt chart uploaded was incorrect; it is more likely a flow chart.
8- In the section "Mice Breed," it says "Swiss" instead of "Swiss Albino mice."
9- In the section "Justification of Animal Number," it says 5 groups of mice, not 6 as stated in the rest of the protocol. Many sentences are also repeated multiple times.
10- In the section "Describe all procedures," it states that there are 40 mice, which is different from the rest of the protocol. Many sentences are also repeated multiple times.
11- The analyses to be performed on the tissues are not explained in detail but are listed as headings.
12- When asked about the pain level, the answer was "minimum," even though the mice will experience seizures.

Informed consent form:

N/A

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