| CTRI Number |
CTRI/2024/10/074889 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the Safety and efficacy of melatonin in Men with Benign Prostatic Hyperplasia (Nocturia). |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled Trial to Compare the Clinical Efficacy
and Safety of Alpha Blocker Versus Alpha Blocker + Melatonin 3 mg in the
Treatment of Men Having Nocturia Associated with Benign Prostatic
Hyperplasia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MELATALPHA/05/24 , Version No: 1.0, Dated: 23.03.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananthakrishnan Sivaraman |
| Designation |
Consultant Urologist, Laparoscopic and Robotic Surgeon |
| Affiliation |
Chennai Urology and Robotics Institute (CURI) |
| Address |
Chennai Urology and Robotics Institute (CURI)
148 Rajiv Gandhi Salai Seevaram Thoraipakkam Chennai
Chennai
TAMIL NADU
600096
India |
| Phone |
9444092277 |
| Fax |
|
| Email |
ananthsiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
Thirumalai Medical Centre,Room No 1, Thirumalai medical centre, No 408 Cuddalaore Road, Nainarmandapam Puducherry
PONDICHERRY
605004
India
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Ki3 Private Limited
No 5 Jayalakshmi Street Radha Nagar Chrompet
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Fourrts (India) Laboratories Pvt.Limited |
|
|
Primary Sponsor
|
| Name |
Fourrts (India) Laboratories Pvt.Limited |
| Address |
Plot No 1 Fourrts Avenue Annai Indira Nagar Okkiyam Thoraipakkam Chennai 600097 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananthakrishnan Sivaraman |
Chennai Urology and Robotics Institute (CURI) |
Chennai Urology and Robotics Institute (CURI)
148, Rajiv Gandhi Salai, Seevaram, Thoraipakkam. Chennai 600096
Chennai
TAMIL NADU |
09444092277
ananthsiv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RIPONINDEPENDENT ETHICS COMMITTEE (RIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOCTURA |
Composition:
Melatonin BP 3mg
Dosage:
1 tablet taken orally just before sleeping at night for 12 weeks. |
| Comparator Agent |
TAMFIL |
Composition:
Tamsulosin Hydrochloride IP 0.4mg
Dosage:
1 tablet taken orally just before sleeping at night for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 poststudy |
Day 0, day 3, day 28, day 56 and day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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) |
Day 0, day 3, day 28, day 56 and day 84 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. This study aims to evaluate the efficacy and safety of an alpha blocker alone compared to an alpha blocker combined with melatonin in treating nocturia associated with Benign Prostatic Hyperplasia (BPH).Inclusion Criteria: - Participants must be 50 years or older.
- Must have nocturia with at least two nocturnal voids per night, with each episode preceded and followed by sleep.
- International Prostate Symptom Score (IPSS) greater than 7.
- Nocturia symptoms present for at least one month prior to enrollment.
- Diagnosis of Benign Prostatic Hyperplasia (BPH) based on medical history.
- Ability and willingness to provide written informed consent.
Exclusion Criteria: - Known structural problems or anomalies of the urinary tract, or recent pharmacological interventions for nocturia (including melatonin).
- Presence of stress or urge incontinence, or a history of urinary tract infections.
- Allergy, hypersensitivity, or contraindications to melatonin, or significant health conditions like uncontrolled diabetes or malignancies.
- Use of medications affecting urination or sleep, regular smoking, alcohol abuse, or participation in another clinical trial within the past 30 days.
2. Sixty men meeting the eligibility criteria will be randomly assigned to two groups: - Group 1: Alpha blocker (Tamsulosin 0.4 mg or Silodosin 8 mg)
- Group 2: Alpha blocker plus melatonin (3 mg).
3. Participants will take their assigned medication orally before bedtime for 12 weeks and maintain a bladder diary to record nocturia episodes.
4. Primary outcomes include - changes in the number of nocturnal voids,
- International Prostate Symptom Score (IPSS),
- urination frequency, and Quality of Life (SF-12).
5. Safety will be assessed by monitoring adverse events and conducting laboratory tests - Complete Blood Count,
- Random Blood Sugar,
- HbA1c,
- Renal Function Test, and
- Liver Function Test).
|