STUDY PROTOCOL
ASSESSMENT OF ANTI-GLAUCOMA POTENTIAL
OF HERBAL FORMULATION IN NEW ZEALAND WHITE RABBITS
1.
INTRODUCTION:
Glaucoma is a group of eye conditions that can cause
blindness. With all types of glaucoma, the nerve connecting the eye to the
brain is damaged, usually due to high eye pressure. Once the optic nerve is
damaged, it fails to carry visual information to the brain and this results in
loss of vision. The most common type of glaucoma (open-angle glaucoma) often
has no symptoms other than slow vision loss.
2.
TEST
SYSTEM DETAILS:
Species
: Rabbit
Strain : New Zealand White
Age : 12-15 Weeks
Body
Wight : 1.5-3.0 kg
Sex : Male
No. of
animals : 6 /Group
Total
No. of animals : 42
3.
ALLOCATION OF GROUPS:
|
Groups |
Treatment |
Dose; ROA (p.o.) |
No. of Animals |
|
G1 |
Normal
Control |
0.25%
Na-CMC |
6 |
|
G2 |
Disease
Control |
0.25%
Na-CMC |
6 |
|
G3 |
Reference
- Acetazolamide |
5mpk
p.o. |
6 |
|
G4 |
Herbal
Formulation-1 |
X
mpk |
6 |
|
G5 |
Herbal
Formulation-1 |
XX
mpk |
6 |
|
G6 |
Herbal
Formulation-2 |
X
mpk |
6 |
|
G7 |
Herbal
Formulation-2 |
XX
mpk |
6 |
4.
METHODOLOGY:
·
Induction
of ocular hypertension in rabbit
·
After basal measurements of
IOPs (Intraocular pressure), ocular hypertension will be induced in rabbits by
instilling 1 % prednisolone acetate in each eye, twice daily (12 hourly) for 21
days, while measuring the IOP weekly (between 8.30 and 9.00 AM).
·
Animals with at least a 50 %
increase in IOP and characterized with one or more of the following clinical
signs: bulging eyeball (buphthalmic eyes), fixed dilated pupils, and sluggish
pupillary reaction, will be selected for this study.
· Assessment of the ocular
hypotensive effect of Test Compounds
· Rabbits
with ocular hypertension will be divided into seven groups.
·
Group G1 animals will be served
as normal control and treated with sodium CMC.
·
Group G2 animals will be served
as disease control and treated with sodium CMC.
·
Group G3 will serve as a reference
drug and be treated orally with reference drug acetazolamide at the dose of 5mg/kg
p.o.
·
Group G4 to G7 treated orally
with test compound at the different dose levels.
· Each
group will be treated orally, with the test sample, vehicle, or drug daily (12
hourly), at different dose levels for 2 weeks with intraocular pressure
measurements being made in each eye every other day for the same period.
·
Furthermore, all the animals
will be humanely sacrificed; both the eyes will be removed, fixed in 10 %
phosphate-buffered paraformaldehyde, and embedded in paraffin for
histopathological assessment.
5.
END
POINT PARAMETER(S):
·
Clinical observation
·
Body weight changes
·
Feed & water consumption
·
Determination of glutathione in aqueous humor
·
Evaluation of glutamate in the vitreous humor
·
Histopathology assessment
6.
REFERENCE(S):
6.1 Samuel
Kyei, George Asumeng Koffuor, Paul Ramkissoon and Osei Owusu-Afriyie.
Anti-glaucoma potential of Heliotropium indicum Linn in experimentally-induced
glaucoma. Eye and Vision (2015) 2:16 DOI 10.1186/s40662-015-0027-1
6.2 Ticho
U, Lahav M, Berkowitz S, Yoffe P, Ocular changes in rabbit with corticosteroid-induced ocular hypertension. Br J Opthalmol. 1979;63:646-50
6.3 Kersey,
J., Broadway, D. Corticosteroid-induced glaucoma: a review of the literature. Eye 20, 407–416
(2006). https://doi.org/10.1038/sj.eye.6701895
6.4 Gupta
S D, Gupta J S, Gupta S B, Mahajan B G. Steroid-induced glaucoma (experimental
study). Indian J Ophthalmol 1969;17:14-6
6.5 Shital
S. Panchal, Anita A. Mehta, Devdas D. Santani. Effect of potassium channel
openers in acute and chronic models of glaucoma. Taiwan Journal of
Ophthalmology. 6 (2016) 131e135
6.6 Source Research Needs YouTube Channel: Diabetes-Induced Erectile Dysfunction Video
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