EVALUATION OF EFFICACY OF TEST FORMULATIONS IN RAT MODEL OF IRON DEFICIENCY DIET INDUCED-ANAEMIA

EVALUATION OF EFFICACY OF TEST  FORMULATIONS IN RAT MODEL OF IRON DEFICIENCY DIET INDUCED-ANAEMIA

1.0  TEST SYSTEM DETAILS:

Species                   : Rattus norvegicus (Rats)

Strain                     : Sprague Dawley or Wistar

Age                        : 3 weeks

Sex                        : Female

No. of animals        : 8/Group

Total animals         : 56

 

2.0  TEST ARTICLES DETAILS

HF-1: Herbal Formulation-1

 

3.0  VEHICLE DETAILThe test articles will be formulated by utilizing 0.5% methylcellulose as th;e vehicle.

4.0   ALLOCATION OF GROUPS:

Group No.	Group Description	Disease Induction procedure	Treatment administered	Dose Volume and Route
G1	Normal Control	Normal Laboratory Diet × 8 weeks	0.5% MC, p.o., q.d.	5 ml/kg, p.o.
G2	Disease Control	All animals will be given a customized iron-deficient diet from the third week of their age × 8 weeks	0.5% MC, p.o., q.d.
G3	Reference Control		Heme Iron Polypeptides -20 mg/kg, p.o., q.d.
G4	Treated with low dose of HF-1		HF-1: 30 mg/kg, q.d.
G5	Treated with intermediate dose 1 of HF-1		HF-1:100 mg/kg, q.d.
G6	Treated with intermediate dose 2 of HF-1		HF-1: 300 mg/kg, q.d.
G7	Treated with high dose of HF-1		HF-1:  1000 mg/kg, q.d.

Abbreviations: MC: Methylcellulose, p.o.-per os. q.d.: quaque die; bid: bis in die.

5.0  METHOD:

·         Healthy animals will be selected for the study, randomized based on body weight, and will be assigned to 7 groups consisting of 8 animals each.

·         Animals of Group G1 will be designated as normal-control and administered 0.5% MC, p.o., q.d.

·         Disease control animals (assigned to group G2) will receive 0.5% MC, p.o., q.d.

·         Animals of group G3 will be treated with reference drug Heme Iron Polypeptides at the dose of 20 mg/kg, p.o., q.d.

·         Animals of group G4-G7 will be treated with HF-1, at different incremental dose levels as outlined in Table, q.d.

·         Normal control group (G1) will be fed a Normal Laboratory Diet, whereas animals allocated to groups G2 – G7 will be fed Iron Deficient Customized diet immediately after randomization for six weeks.

·         Compound administration will be initiated from day 43 for two weeks (till day 56), after confirmation of Iron Deficiency Anaemia in groups G2-G7.  

·         On day 0, before the initiation of iron-deficient diet, blood parameters will be determined for the baseline data. Iron-deficient diet will be given for 6 weeks and haematological changes will be evaluated every two-weeks for hematological changes and confirmation of anaemia.  Animals will be treated with formulations/Reference drug/vehicle for two weeks after confirmation of anaemia. Subsequently, after week eight on day 57, all animal will be sacrificed under overdose of thiopentone anaesthesia. After suitable anaesthesia but before the animal dies, blood will be collected from the retro-orbital plexus for the estimation of haematological parameters. Immediately after the animal dies, the liver, kidneys, and spleen will be weighed and will be fixed in 10% neutral buffered formalin for histopathological whereas some parts of the organ and one organ among from pair of organs will be stored at -80°C for the ensuing biochemical and molecular evaluations.

 

6.0  PARAMETERS TO BE EVALUATED:

·         Body weight: Twice a week.

·      Blood parameters: RBC Count, WBC Count, Packed Cell Volume/Hematocrit, Hemoglobin, Serum iron, Serum Ferritin, Total Iron Binding Capacity, Unsaturated iron-binding capacity.

·         Iron content in the liver and kidney.

·         Histological analysis of the Liver, Kidney, and Spleen.

 

7.0  REFERENCE(S):

1.  Suehiro, D. et al. Maltobionic acid accelerates recovery from iron deficiency-induced anemia in rats. Biosci. Biotechnol. Biochem. 84, 393–401 (2020).

2.  Kapil Thakur, M., Sameer Kulkarni, S., Mohanty, N., N. Kadam, N. & S. Swain, N. Standardization & Development of Rat Model with Iron Deficiency Anaemia Utilising Commercial Available Iron Deficient Food. Biosci. Biotechnol. Res. Asia 16, 71–77 (2019).

3.  Susanti, T., Dirgahayu, P. & Indarto, D. Development of Rat Model with Iron Deficiency Anemia by Modification of Its Standard Food. 5–9 (2018) doi:10.2991/phico-17.2018.22.

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