Report

Protocol Title: Anti-Parkinson’s Potential of Ficus lyrata Warb. Leaf Extract: In-vivo and In-silico Studies

Principal Investigator: Dr. Noha El Nowihy

Committee Ethical Review Comments:

1-Scientific and Social Value:

The research work aims to treat and control Parkinson’s disease using Ficus Lyrata, an edible, cheap, and readily available natural product. The team has the experience to cover the plan of work.

2-The English title must be: Anti-Parkinson’s disease Potential of Ficus lyrata Warb. Leaf Extract: In-vivo and In-silico Studies

or

Anti-Parkinsonism Potential of Ficus lyrata Warb. Leaf Extract: In-vivo and In-silico Studies.

3- Background: There is a need for additional research on the use of rotenone and levodopa, which are employed in the induction and treatment of Parkinsonism, respectively.

4-Objective: The term "discovery" in the secondary objective should be changed to "detection" as there is no discovery in the plan of work; the biochemical analysis of Ficus lyrata leaves has already been conducted (Bhangale et al., 2015; Mousa et al., 2025).

5- Funding: The amount of funds required for the research must be specified in the protocol. 6-Use of Animals: 45 male rats will be used in the experiments. 15 rats will be used to study the LD50 of the Ficus lyrata leaf extract. The LD50 test must be conducted using rotenone, a toxic pesticide, so 15 rats will be required for this experiment. 30 rats will be divided into 5 groups of sex rats each. They must take into consideration that more than one rat will die due to the injection of rotenone.

7-Duration of experiment:28 days is not enough to finish the work; it is just for animal experiments, while the biochemical and histopathology examinations will need two months more.

8-Waste management and occupational safety plans are missing.

9- There are mistakes in Gantt Chart and Flowchart must be changed.

Ethical Conclusion: Ethical approval is conditionally recommended, provided that:

-Change the title

-Add more information in the background

-Objective expression must be reasonable

-The fund amount must be included

-The number of animals must be increased to determine the LD50 for the rotenone and avoid errors in statistics due to death during the work.

-The duration of work must be more than 28 days to include the time needed for biochemical and histopathology work.

-It is essential to include waste management and occupational safety plans in the proposal.

-Gantt Chart and Flowchart must be changed