A clinical study to see the effect of some Ayurvedic formulations in the treatment of Urinary stone.

Phase 2

• Conditions: Health Condition 1: null- Urolithiasis

• Registration Number: CTRI/2012/05/002640
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged 18-65 years

2. Radiological / Ultrasonological evidence of single calculus / multiple calculi < 10 mm each, present in kidney(s)/ ureter(s) / urinary bladder.

3. Willing and able to participate for 16 weeks

Exclusion Criteria

1. Urinary Tract Infection (UTI)

2. Patients with obstructive uropathy

3. Patients with known metabolic/endocrinal disorder favouring calculus formation.

4. Patients with evidence of malignancy.

5. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).

6. Patients suffering from major systemic illness necessitating long term drug .treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)

7. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

8. Symptomatic patients with clinical evidence of Heart failure.

9. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)

10. Patients on prolonged (>= 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

11. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL).

12. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease or any other condition that may jeopardize the study.

13. Alcoholics and/or drug abusers.

14. H/o hypersensitivity to any of the trial drugs or their ingredients.

15. Patients who have completed participation in any other clinical trial during the past six (06) months.

16. Pregnant or lactating woman.

17. Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢ Expulsion of calculus <br/ ><br>â?¢ Change in Size of calculusTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Secondary Outcome Measures

Name	Time	Method
â?¢ Symptomatic improvement <br/ ><br>â?¢ Change in quality of life (SF-36 Heath Survey Score)Timepoint: Symptomatic improvement assessment at Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. <br/ ><br>SF-36 Heath Survey Score assessment at Baseline, at 84th day and after completion of follow up at the end of 16 weeks.