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

Phase 4

Completed

Conditions: Health Condition 1: N200- Calculus of kidney

Registration Number: CTRI/2023/04/051931

Lead Sponsor: Vasu Research Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

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).

2. Aged between =18 to = 50 years.

3. Subjects willing to sign informed consent and follow the study

procedure and instructions.

4. 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 = 200mg/dl during the screening period, can

be included in the study.

Exclusion Criteria

1. Subjects with severe obstructive uropathy, those with serious

systemic medical disorder- uncontrolled hypertension and

diabetes mellitus, other metabolic disorders, endocrinal

disorders and cardiac illness.

2. The subjects not to have used any drugs, for at least 1 week

prior to the study for concurrent illness with diabetes and

Hypertension.

3. Subjects with a strong history of food or drug allergy of any

kind

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures