Health Condition 1: null- Benign Prostate Hypertrophy (BPH)
Conditions
Interventions
Intervention1: Kanchanara Guggulu: Dose â?? 1gm (2 Tablets) twice daily
Dosage form - Tablet of 500 mg
Route of Administration â?? oral
Time of Administration-Twice a day after food
Anupana-Lukewarm
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with age between 45 and 70 years. 2. Patients with American Urology Association (AUA) symptom score > 8 and 3. Rectal examination consistent with Benign Prostate Hypertrophy (BPH) 4. Prostate volume > 30cc 5. Prostate Specific Antigen (PSA) 6. Urine flow rate of >5 to 7. Willing and able to participate in the study for 16 weeks.
Exclusion criteria
Exclusion criteria: 1. Patients with severe Benign Prostate H (AUA score >21) 2. Patients currently using any other form of medical therapy for BPH/ Hair loss 3. Patients with H/O Transurethral Resection of Prostate (TURP) 4. Serum Prostate Specific Antigen (PSA) > 4 ng/ml 5. Chronic retention of urine (Post voidal urine volume > 150ml) 6. Refractory bacteriuria 7. Patients with persistent gross haematuria 8. Patients with evidence of malignancy 9. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 10. Patients with poorly controlled Hypertension ( > 11. 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. 160 / 100 mm Hg) 12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 13. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 14. Symptomatic patient with clinical evidence of Heart failure. 15. 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), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study. 16. Alcoholics and/or drug abusers. 17. H/o hypersensitivity to any of the trial drugs or their ingredients. 18. Patients who have completed participation in any other clinical trial during the past six (06) months. 19. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in AUA symptom score during the period of 12 weeks. â?¢ Change in Quality of Life (QOL) Index.Timepoint: AUA scoring is done at Baseline, at 14th day, at 28th day, at 42nd day, at 56th day, at 70th day, at 84th day andat the end of follow up at 16 weeks. QOL score is done at Baseline, at 84th day and at the end of follow up period at 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in the post voidal residual volume of urine â?¢ Improvement in Peak urine flow rate.Timepoint: At Baseline, at 84th day and at the end of follow up at 16 weeks. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed