Health Condition 1: null- Urolithiasis
Conditions
Interventions
Packing form- Plastic jar containing 30 sachets of 25 gm each
Intervention1: Palashaa Kshara: Dose-One tablets (500 mg) twice daily
Dosage form- Tablets
Route of Administration-Oral
Time of Administration-Twice a day after food Anupana- Water
Packing form-Pla
Dosage form- Tablets
Anupana- Water
Packing form-Plastic jar containing 30 hard gelatin capsules of 500 mg each
and
Duration of therapy-12 weeks Along With PASHANBHEDA KWATHA CHURNA-Dose- 25 gm twice daily
Dosage form-Kwath churna (Coarse powder for decoction)
and Duration of therapy-12 weeks.
Intervention3: Pashanbheda Kwatha Churna: Dose- 25 gm twice daily Dosage form-Kwath churna (Coarse powder for decoction)
Route of Administration-Oral
Time of Admini
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged 18-65 years 2. Radiological / Ultrasonological evidence of single calculus / multiple calculi 3. Willing and able to participate for 16 weeks
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Expulsion of calculus 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
| Measure | Time frame |
|---|---|
| â?¢ Symptomatic improvement 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. SF-36 Heath Survey Score assessment at Baseline, at 84th day and after completion of follow up at the end of 16 weeks. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed