CTRI/2023/04/051931
Completed
Phase 4
A Open label Clinical Study to Evaluate the Efficacy and Safety of URAL Tablet in Urolithiasis
Vasu Research Centre0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vasu Research Centre
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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