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

A Open label Clinical Study to Evaluate the Efficacy and Safety of URAL Tablet in Urolithiasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051931
Enrollment
50
Registered
2023-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

None listed

Sponsors

Vasu Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject with Urolithiasis as diagnosed by clinical with calculi measuring 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1.Safety profile and overall compliance 2. Self-reported AEs & SAEsTimepoint: Day 1, Week 4, Week 8, Week 12

Countries

India

Contacts

Public ContactMeena Dalal

Rescue Urology Center

dr.csratkal@gmail.com9845255378

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026