A clinical study to see the effect of some Ayurvedic formulations in the patients of Prostate enlargement.

Phase 2

• Conditions: Health Condition 1: null- Benign Prostate Hypertrophy (BPH)

• Registration Number: CTRI/2012/04/002586
• 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 with age between 45 and 70 years.

2. Patients with American Urology Association (AUA) symptom score > 8 and < 21

3. Rectal examination consistent with Benign Prostate Hypertrophy (BPH)

4. Prostate volume > 30cc

5. Prostate Specific Antigen (PSA) < 4 ng/ml

6. Urine flow rate of >5 to <15ml/sec for 2 voids

7. Willing and able to participate in the study for 16 weeks.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified