National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Purslane Leaf Extract: A Novel Therapeutic Approach to Mitigate 4-(Methylnitrosamino)-1-(3-pyridyl)-1-buta-4 None (NNK)-Induced Testicular Histopathological Alterations and Hormonal Imbalances in Male Rats.

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

- Title in English: Needs to be modified as: Purslane Leaves Extract: A Novel Therapeutic Approach to Mitigate of Induced Testicular Histopathological Alterations and Hormonal Imbalances by compound 4-(Methylnitrosamino)-1-(3-pyridyl)-1-buta-4 None (NNK) in Male Rats.

- Title in Arabic: Needs to be modified as:

مستخلص أوراق الرجلة: نهج علاجي جديد للتخفيف من التغيرات النسيجية المرضية في الخصية والاختلالات الهرمونية الناجمة عن مركب 4-(ميثيل نيتروزامينو)-1-(3-بيريديل)-1-بيوتا-4 نون (NNK)  في ذكور الفئران

- Principal Investigator Data: Role/tasks: It is written that Principal Investigator, required to write tasks.

- Reviewing the protocol by scientific committee: written No.

- Research Team: Co-Investigator: The procedure he /she is responsible: written in all (4 Co-Investigator), the same tasks (1. Injection of animals 2. Blood sampling 3. Sacrifice 4. Biochemical tests).

- Background: Written in second paragraph Figure1. Portulaca oleracea picture. There is no Figure.

- Procedure in Details: There are no details of anything, and only 4 lines are written representing the stages of the Search.

- Sample size and groups: Written 10 rats in group, it’s not written a number of groups.

- Gant-chart: Written 3 charts.

   * It can be enough by one chart (the second).

   * In the third chart is written portulaca seeds fractions, It's not leaves.

   * Written in the third and fourth chart M6, M7, …… M12. While the study is only two months.

 

 

 

Flow-chart: Repeated Gant-chart.

- Describe all procedures on the animals and how done:

     * Dose of compound NNK (1.5 mg/kg body weight). The basis for choosing this dose was not mentioned.

     * Dose of Portulaca ether extract (500 mg /kg/day). The basis for choosing this dose was not mentioned.

- You mentioned will be done Seminal quality and Histopathological Examination. You did not mention the details of the procedure and the parameters that will be evaluated.

- Drug/Agent: Written alcoholic extract. While study used Ether extract.

- Collection of biological samples: Written Sample: blood. While There are Seminal quality (Semen) and Histopathological Examination (Tests tissues).

- Sample amount (size/ volume): 3 to 5 ml. This quantity is considered a lot.

- In the third stage of search (3- In vitro cytotoxicity assay). Did not give any details.

- The anticipated pain or distress for animals: Mentioned no pain or slight pain. How, with:

    * Orally Rats for 8 weeks (experimental period) using a gastric tube.

    * Subcutaneously injected three times weekly for four weeks

    * Take blood samples.

    * Take semen samples.

Comment to the Committee

Informed consent form:

N/A

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