EVALUATION OF THE EFFICACY OF TEST FORMULATIONS IN RAT MODEL OF PROPYLTHIOURACIL (PTU)-INDUCED HYPOTHYROIDISM
1.0 TEST SYSTEM DETAILS
Species : Rattus
norvegicus (Rats)
Strain : Sprague-Dawley
Age : 6-7
weeks
Body Weight : 180-230 g
Sex : Female
No. of animals : 8 Animals in
each group
Total animals : 56
Study Duration: :50 days
2.0
ALLOCATION OF GROUPS:
|
Group No. |
Group Description |
Disease Induction agent administered |
Treatment administered |
Dose Volume 4Route |
|
G1 |
Normal Control |
0.5 % MC |
0.5% MC |
5 ml/kg, p.o. |
|
G2 |
Disease Control |
PTU-10 mg/kg, p.o. in 0.5%
MC × 30 days |
0.5% MC |
|
|
G3 |
Reference Control |
Thyroxine-100 µg/kg, q.d.
in 0.5% MC |
||
|
G4 |
Treated with low dose of TEST-X1 |
TEST-X1
mg/kg, b.i.d. in 0.5% MC |
||
|
G5 |
Treated with intermediate dose 1 of TEST-X2 |
TEST-X2
mg/kg, b.i.d. in 0.5% MC |
||
|
G6 |
Treated with intermediate dose 2 of TEST-X3 |
TEST-X3
mg/kg, b.i.d. in 0.5% MC |
||
|
G7 |
Treated with high dose of TEST-X4 |
TEST-X4
mg/kg, b.i.d. in 0.5% MC |
X1, X2, X3, and X1, are defined as the incremental doses of the Ayurvedic formulations. MC-Methyl Cellulose, p.o.-per os. The dose range will be from 10 mg/kg to 1000 mg/kg, q.d: quaque die, bid: bis in die
3.0 METHOD:
All rats, weighing 180-230g will be procured, randomized based on body weight and allocated into 7 different groups consisting of 8 animals each.Animals in the normal control groups will be administered 0.5% MC, p.o.
Animals of groups G2 to G7 will be rendered hypothyroid by oral administration of Propylthiouracil (PTU) orally for 30 days.
Animals of group, G2 will be administered 0.5% MC.
Animals of group, G3 will receive thyroxine, orally at the dose of 100 µg/kg.
Animals of groups G4 to G7 will receive the test Formulations (X1, X2, X3 and X4) , orally at dose levels ranging from 10 mg/kg to 1000 mg/kg b.i.d.
At the end of the treatment period, all animals will be fasted for 6 h, blood will be collected from the retro-orbital plexus and a drop will be used for glucose measurement, the remaining being allowed to clot for 30 min at room temperature. Serum will be separated by centrifugation at 2500 rpm at 30 °C for 15 min and used for the estimation of T3, T4, TSH, homocysteine (Hcy), total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), creatinine, cortisol, uric acid, and total protein content. Fasting serum insulin concentration will also be measured using the insulin Radioimmunoassay (RIA) kit.· Thyroid gland will be collected for histopathology.
END POINT PARAMETER(S):
·
Weekly body weight and feed consumption
·
Serum T3, T4 and TSH levels.
·
Serum Hcy, TC, TG, HDL, LDL, Cortisol, TP etc.
·
Fasting serum insulin concentration.
·
Thyroid histopathology.
4.0
REFERENCE(S):
4.1 S. Ashwini, Zachariah Bobby, M. G. Sridhar, and C. C. Cleetus. Insulin
Plant (Costus pictus) Extract Restores Thyroid Hormone Levels in Experimental
Hypothyroidism. Pharmacognosy Res. 2017 Jan-Mar; 9(1): 51–59.
4.2
Sneha Singha, et al. Protective
effect of a polyherbal bioactive fraction in propylthiouracil induced thyroid
toxicity in rats by modulation of the hypothalamic–pituitary–thyroid and
hypothalamic–pituitary–adrenal axes. Toxicology Reports 7 (2020) 730–742
END OF THE DOCUMENT
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