STUDY PROTOCOL
EVALUATION OF HERBAL FORMULATIONS ON PHENYLHYDRAZINE-INDUCED ANAEMIA IN
RATS.
1.0
TEST SYSTEM DETAILS:
Species : Rattus norvegicus (Rats)
Strain : Albino Wistar
Age : 8-12 weeks
Body Wight : 200-250 g
Sex : Male
No. of animals : 8 Animals in each group
Total animals : 48+0 Extra (Total = 48)
Study Duration :
30 Days
2.0
ALLOCATION OF GROUPS:
|
Groups |
Treatment |
Dose;
ROA |
Animal Numbers |
|
G1 |
Normal Control |
Distillated water |
8 |
|
G2 |
Negative Control |
Distillated water |
8 |
|
G3 |
Standard Control
|
20% ferritin
extract glycerin Hydrate (p.o.) Daily (or Commercially available iron supplements) |
8 |
|
G4 |
Plant Extract/Herbal Formulation-1 |
X1
mpk; p.o. |
8 |
|
G5 |
Plant Extract/Herbal Formulation-1 |
X2
mpk; p.o. |
8 |
|
G6 |
Plant Extract/Herbal Formulation-1 |
X3
mpk; p.o. |
8 |
No animals will be taken
extra in study for the randomization purpose; X1-4, and Y1-4 is defined as
various concentrations of formulations.
3.0
METHOD:
·
Healthy
animals will be selected, randomized based on, the initial concentration of
hemoglobin should be 11 g/dl or more and the animals will be allocating in into
11 different groups consisting of 8 animals each.
·
Anemia
will be induced by intraperitoneal injection of phenylhydrazine at 40 mg/kg for
2 days.
·
Normal control and Negative control groups will receive only Distillated water q.s.
·
All
rats will be anesthetized with 75mpk Ketamine combination with 10 mpk Xylazine.
The blood exsanguinations should not be more than 0.5 ml. (This volume does not
affect blood parameters as indicated previously).
·
In
the normal control animals, no exsanguinations will be conducted, but the
systemic anesthesia will be performed.
·
Animals
will be monitored for body weight that will have recorded daily.
·
Moreover,
about 0.5 ml of blood will collected from each animal into a 5 ml EDTA tube by
tail vein with syringe needles.
·
The
hematological analyses will perform within 24 hr of blood collection. The first
set of blood samples of all the animals in the all groups will be collected
before the induction of anemia (for day 0).
·
The
second set of blood samples will be collected three days after the induction of
anemia (day 3).
·
The
third set of blood samples will be collected on day 7, 10 & 15 later.(Pandey
et al. 2016) (Diallo
et al. 2008)
4.0
END POINT PARAMETER(S):
RBC
Count, WBC Count, Packed Cell Volume/Hematocrit, Hemoglobin, Serum iron, Serum
Ferritin, Total Iron Binding Capacity, Unsaturated Iron-Binding Capacity and Histopathology- Liver, Kidney and
Spleen
5.0
REFERENCE(S):
5.1 Lee, H.W., Kim, H., Ryuk, J.A., Kil,
K.-J., Ko, B.S., 2014. Hemopoietic effect of extracts from constituent herbal
medicines of samul-tang on phenylhydrazine-induced hemolytic anemia in rats.
International journal of clinical and experimental pathology 7(9), 6179.
5.2 Diallo,
Aboudoulatif, Messanvi Gbeassor, Ahoefa Vovor, Kwashie Eklu-Gadegbeku, Kodjo
Aklikokou, Amegnona Agbonon, Ange A. Abena, Comla de Souza, and Koffi Akpagana.
2008. “Effect of Tectona Grandis on Phenylhydrazine-Induced Anaemia in Rats.” Fitoterapia
79 (5): 332–36. https://doi.org/10.1016/j.fitote.2008.02.005.
5.3 Pandey, Stuti,
Aditya Ganeshpurkar, Divya Bansal, and Nazneen Dubey. 2016. “Hematopoietic
Effect of Amaranthus Cruentus Extract on Phenylhydrazine-Induced Toxicity in
Rats.” Journal of Dietary Supplements 13 (6): 607–15.
https://doi.org/10.3109/19390211.2016.1155685.
5.4 Chauhan, SanjayP,
NavinR Sheth, and BhanubhaiN Suhagia. 2015. “Hematinic Effect of Fruits of
Opuntia Elatior Mill. on Phenylhydrazine-Induced Anemia in Rats.” AYU (An
International Quarterly Journal of Research in Ayurveda) 36 (2): 208.
https://doi.org/10.4103/0974-8520.175549
END OF DOCUMENT
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