FORM 2 THE PATENT ACT, 1970
(39 of 1970)
COMPLETE SPECIFICATIONS
[See section 10; rule 13]
1. Title of Invention: "Antiurolithiatic activity of a polyherbal product Unex "
2.

Name
Nationality
Address
Showkat Ahmad Patni Indian Nigeen Bagh Krankshivan Colony, Sopore, Kashmir 193 201, J&K.
Anwar Siraj Daud Indian No. 131, Daud Compound, Near Husamiya High School Shantinagar, Nagpur-440 002, Maharashtra, India.
Shamsuddin Jamalludin Indian Hameed panelwan chal sauf/nagar,Mominpura 440018 Nagpur
Suhail Asghar . Indian Behind Zaheer warsi bldg warispura kamptee 441002
Gupta vipin Bihari Indian TIFAC CORE in Green Pharmacy, B R Nahata College of Pharmacy, P.O. Box No. 6, Mhow-Neemuch Road, MANDSAUR (MP) 458001 India
Edwin Jarald Indian TIFAC CORE in Green Pharmacy, B R Nahata College of Pharmacy, P.O. Box No. 6, Mhow-Neemuch Road, MANDSAUR (MP) 458001 India
Pankaj Kushwah Indian TIFAC CORE in Green Pharmacy, B R Nahata College of Pharmacy, P.O. Box No. 6, Mhow-Neemuch Road, MANDSAUR (MP) 458001 India

The following specifications (particularly) describes the nature of this invention
(and the manner in which it is to be performed): -

Description of the Invention (to start from second page)
Urolithiasis or formation of urinary calculi at any level of the urinary tract is a common condition and are worldwide in distribution but are particularly common in some geographic locales such as in parts of the United States, South Africa, India and South-East Asia. It is estimated that approximately 12% of the population experiences renal stone disease at sometime in their life with male -female ratio of 2:1. The peak incidence is observed in 2" and 3r decades of life. Renal calculi are characterized clinically by colicky pain. There are various herbal drugs that are active against the kidney stone formation.
The present invention relates with the discovery of one such polyherbql product, Unex manufactured by Unijules Life Sciences Ltd., and Associated Companies, Nagpur, containing the extracts of Boerrhavia diffusa and Tribulus terrestris in the ratio of 2:1, which has been found effective in prevention of formation of kidney stones.
Boerrhavia diffusa and Tribulus terrestris are commonly available herbs.
Methods: Various steps involved in the aforementioned process are:
1. The aqueous extracts of both the plants were prepared and mixed in the above mentioned ratio. This was then pellatized and filled in capsules.
2. The capsules were procured from the Unijules Life Sciences Ltd., and Associated Companies, Nagpur
3. A study was conducted to determine the effects of Unex in kidney stone formation, serum parameters related to urolithiasis and urine volume output.
4. Animal model studied was Ethylene glycol induced model.
5. Cyst one 750 mg/kg was used as the standard drug to compare the efficacy of
Unex.

6. The capsule Unex prevented the rise of oxalate, calcium and phosphate which are the main markers of urolithiasis (Table J).
7. Stone formation leads to the increased levels of blood urea nitrogen, creatinine and uric acid. Treatment with Unex has restored these values significantly (Table 2).
8. Increased urinary output was identified in the Unex treated group, which confirms its activity as diuretic.
9. Unex has prevented the rise in pH of treated group when compared to model control group.
From the above said observation following inferences could be drawn. J. Unex is a potent antiurolithiaiic drug.
2. It can be used to dissolve the formed stones.
3. Along with antiurolithiaiic agent it is diuretic too.
We Claim:
1. Unex prevents the stone formation in kidney.
2. Unex dissolves the formed stones.
3. Unex could be used as a diuretic drug.
4. Unex can be used as a preventive regimen too due to its safety profiles.
5. Unex has the ability to bring back the elevated serum parameters that are considered as markers in kidney diseases to normal.

Antiurolithiatic activity of Unex
Table 1. Effect of Unex in Urine Parameters

s.
No Groups & dose Urine parameter


Oxala te Calcium Phosphate
1 Normal control 0.35± 0.023*** 0.35 ±0.22*** 3.66 ±0.25***
2 Model control 3.48 ±0.17 4.16 ±0.22 6.98 ±0.07
Cystone (std drug) 0.52±0.0l*** 1.46 ±0.02*** 3.40 ±0.03***
4 Unex (200 mg/kg) 0.81 ±0.01*** 1.46 ±0.04*** 4.20 ±0.22***
5 Unex (400 mg/kg) 0,99 ±0.05*** 1.88 ±0.07** 4.33 ±0.21***
*P<0.05, **p<0.01, ***p<0.001 Vs model control (n = 6). Values are expressed in , Mean ± SEM, Statistics: one way ANOVA followed by Bonferroni test. *** highly significant, **significant,* less significant.
Table 2, Effect of Unex in Serum Parameters

S.No. Groups & Dose Serum Parameter

BUN Creatinine Uric acid
1 Normal control 32.16 ±2.56*** 0.72 ±0.02*** 1.47±0.033***
2 Model control 46.28 ±2.59 I.4I ±0.05 2.09 ± 0.08
3 Cy stone (std drug) 36.40 ±2.16*** 0.84 ±0.02** 1.49 ±0.11***
4 Unex (200 mg/kg) 39.07 ±0.08*** 0.87±0.01** 1.59 ±0.66***
5 Unex (400 mg/kg) 41.26±1.37** 0.86 ±0.01** 4.07 ±0.05***
*P<0.05, **p<0.01, ***p<0.001 Vs model control (n = 6). Values are expressed in Mean ± SEM, Statistics: one way ANOVA followed by Bonferroni test. *** highly significant, **significant,* less significant.

Table 3. Effect of Unex in Total urinary volume
S.No. Groups & Dose Total urinary volume(ml)
1 Normal control 1.90 ±0.23*
2 Model control 1.45 ±0.22
3 Cystone (std drug) 4.35 ±0.22***
4 Unex (200 mg/kg) 4,43 ±0.31***
5 Unex (400 mg/kg) 4.31 ±0.19***
*P<0.05, **p<0.01, ***p<0.001 Vs model contro (n = 6). Values are expressed in Mean ± SEM, Statistics: one way ANOVA followed by Bonferroni test. *** highly significant, **significant,* less significant.
Table 4. Effect of Unex in Urine pH

- S.No. Groups & dose pH of urine
1 Normal control 7.01 ±0.21***
2 Model control 9.00 ±0,17
3 Cystone (std drug) 7.18±0.19***
4 Unex (200 mg/kg) 7,18±0.21***
5 Unex (400 mg/kg) 7.16 ± 0.17***
*P<0.05, **p<0.01, ***p<0.001 Vs model control (n = 6). Values are expressed in Mean ± SEM, Statistics: one way ANOVA followed by Bonferroni test. *** highly significant, **significant,* less significant.