Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Noctura: Composition:
Melatonin BP 3mg
Dosage:
1 tablet taken orally just before sleeping at night for 12 weeks.
Intervention2: NOCTURA: Composition:
Melatonin BP 3mg
Dosage:
1 tab
Sponsors
Fourrts (India) Laboratories Pvt.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 50 years or older 2. Clinical diagnosis of nocturia, defined as at least 2 nocturia episodes per night, with each episode preceded and followed by sleep 3. International Prostate Symptom Score (IPSS) greater than 7 4. Nocturia symptoms present for a minimum of one month prior to enrollment 5. Diagnosed with Benign Prostatic Hyperplasia (BPH) based on medical history 6. Willingness and ability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Known structural problems or embryological anomalies of the urinary tract (including urethral stenosis) 2. Pharmacological intervention for nocturia (including melatonin) within one month preceding enrollment 3. Presence of stress or urge incontinence History of urinary tract infections (based on medical records) 4. Known allergy, hypersensitivity, proven inefficiency, or contraindications to melatonin or its excipients 5. History of cardiopulmonary or cerebral diseases, hepatic or renal dysfunction, or hypertension HbA1c greater than eight percent 6. Uncontrolled diabetes mellitus, diabetes insipidus, or clinically significant microalbuminuria 7. History of malignancy (including prostate cancer), chemotherapy, or radiotherapy 8. Use of medications that might cause disturbances in urination or sleep (such as diuretics, tranquilizers, or hypnotics) 9. Use of corticosteroids, sleeping pills, or antidepressants 10. Use of medications that interact with the pharmacokinetics of melatonin (such as carbamazepine, quinolones, rifampicin, cimetidine, or estrogen) within one month preceding enrollment Regular cigarette smoking (at least one per day or equivalent) 11. Alcohol abuse (more than four drinks on any day or more than fourteen drinks per week) 12. Autoimmune disease or use of immunosuppressive drugs 13. Rare hereditary conditions such as galactose/lactose intolerance or galactose malabsorption 14. History of Rapid Eye Movement (REM) sleep disorder 15. Neurological or psychological abnormalities Participation in another clinical trial within the past thirty days 16. Any other condition(s) that, in the opinion of the Investigator, would make the patient unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in the number of nocturnal voids per night from baseline to 12 weeks post study 2. Change in the International Prostate Symptom Score (IPSS) from baseline to 12 weeks poststudy 3. Change in the frequency of urination from baseline to 12 weeks poststudy 4. Subject-rated improvement (worsened, no change, or improved) at the end of 12 weeks of treatment. 5. Changes in Quality of Life as measured by the Short Form Health Survey (SF-12) from baseline to 12 weeks poststudyTimepoint: Day 0, day 3, day 28, day 56 and day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of adverse events (AEs) and serious adverse events (SAEs) occurring during the study period. Monitoring and assessment of laboratory abnormalities, including: Complete Blood Count (CBC) Random Blood Sugar (RBS) HbA1c Renal Function Test (RFT) Liver Function Test (LFT)Timepoint: Day 0, day 3, day 28, day 56 and day 84 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed