A clinical study to evaluate the efficacy and safety of URAL tablet

Phase 4

Completed

Brief Summary: Renal Calculi is a common condition experienced by individuals across the world population. Renal calculi are also known as Urolithiasis and commonly called Kidney stones. Kidney stones are mainly composed of calcium salts, uric acid, cysteine, and struvite. Calcium oxalate and calcium phosphate are the most common types accounting for >80% of stones, followed by uric acid (8â€“10%) and cysteine, struvite in remainders.The main aim of the present study is to evaluate the safety and efficacy of URAL tablets inreduction in size of calculi deposits and recovery from the clinical signs and symptoms of renal calculi.This is a randomized, open labelled clinical study to evaluate efficacy and safety of URAL tablets in subjects with Urolithiasis.The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.

Recruitment & Eligibility

Inclusion Criteria

1.Subject with Urolithiasis as diagnosed by clinical with calculi measuring < 10mm.
Hematologic and Biochemical parameters within normal limits (Study specific parameters: calcium, uric acid cannot be more than 2 times upper limit of normal value).
Aged between â‰¥18 to â‰¤ 50 years.
Subjects willing to sign informed consent and follow the study procedure and instructions.
Subjects who are diagnosed of diabetes mellitus, whose blood glucose level is under good control with consumption of Anti-hyperglycemic medications and the Random Blood Sugar (RBS) reading is â‰¤ 200mg/dl during the screening period, can be included in the study.

Exclusion Criteria

Subjects with severe obstructive uropathy, those with serious systemic medical disorder- uncontrolled hypertension and diabetes mellitus, other metabolic disorders, endocrinal disorders and cardiac illness.
The subjects not to have used any drugs, for at least 1 week prior to the study for concurrent illness with diabetes and Hypertension.
Subjects with a strong history of food or drug allergy of any kind.

Primary Outcome Measures

Name	Time	Method
Dysuria, Nausea/vomiting, frequency of micturition, fever.	Day 1, Week 4, Week 8, Week 12
3. Improvement in laboratory parameters: Hematological, Serological, Urine,	Day 1, Week 4, Week 8, Week 12
Radiological.	Day 1, Week 4, Week 8, Week 12
1.Reduction in calculi deposit/kidney stone size	Day 1, Week 4, Week 8, Week 12
2. Recovery in clinical symptoms and signs like Colicky pain at the loin, Hematuria,	Day 1, Week 4, Week 8, Week 12

Secondary Outcome Measures

Name	Time	Method
1.Safety profile and overall compliance	2. Self-reported AEs & SAEs

Locations (2): Ratkal Speciality Hospital Pvt. Ltd.
🇮🇳
Rural, KARNATAKA, India
SDM Institute of Ayurveda and Hospital
🇮🇳
Bangalore, KARNATAKA, India
Ratkal Speciality Hospital Pvt. Ltd.
🇮🇳Rural, KARNATAKA, India
Dr Chandrashekar S Ratkal
Principal investigator
9845255378
dr.csratkal@gmail.com