| CTRI Number |
CTRI/2024/05/067789 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial on lower urinary tract symptoms and male menopausal symptoms |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of fenugreek extract in comparison with placebo in men with lower urinary tract symptoms and male menopausal symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Daehan/Fenugreek/BPH/2024/1.0 Ver1.0 dated 16February2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hanumantha Raju BK |
| Designation |
Principal investigator |
| Affiliation |
Kempegowda Institute of Medical Sciences and Hospital |
| Address |
First floor Room number 2 Department of Urology KR Road,
Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru
Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9880759539 |
| Fax |
|
| Email |
drhanumantharaju@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVijendra R |
| Designation |
Head-Medical services |
| Affiliation |
Bangalore Clinical Services |
| Address |
Novel Tech Park No 46/4 Ground floor, Hosur Road, Kudlu Gate
Bengaluru-560 068 Karnataka, India.
Bangalore
Bangalore
KARNATAKA
560 068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVijendra R |
| Designation |
Head-Medical services |
| Affiliation |
Bangalore Clinical Services |
| Address |
Novel Tech Park No 46/4 Ground floor, Hosur Road, Kudlu Gate
Bengaluru-560 068 Karnataka, India.
Bangalore
Bangalore
KARNATAKA
560 068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
|
Source of Monetary or Material Support
|
| Daehan chemtech co., Ltd B-1208, 65, Gwacheon-Daero 7-Gil Gwacheon-Si, Gyeonggi-Do
13840, South Korea |
|
|
Primary Sponsor
|
| Name |
Daehan chemtech co., Ltd |
| Address |
B-1208, 65, Gwacheon-Daero 7-Gil Gwacheon-Si, Gyeonggi-Do 13840, South Korea |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
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 Hanumantha Raju BK |
Kempegowda Institute of Medical Sciences and Hospital |
First floor Room number 2 Department of Urology KR Road,
Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru
Bangalore
Bangalore
KARNATAKA |
9880759539
drhanumantharaju@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
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 |
Fenugreek extract |
Dose: 500mg
Dosage form: Capsules
Route of administration: Orally
Frequency: One capsule orally in the morning before breakfast
Duration:84 days
|
| Comparator Agent |
Placebo |
Dose: 500mg Dosage form: Capsules Route of administration: Orally Frequency: One capsule orally in the morning before breakfast Duration:84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Male greater than or equal to 40 to less than or equal to 70 years of age.
2. Testosterone range between 3.0-5.0 ng/mL.
3. At screening, subject has a
IPSS greater than or equal to 8 and less
than or equal to 19
AMS score greater than or equal 27 to less
than or equal to 50
4. Must be willing and able to give informed consent and comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a history of prostate cancer or carcinoma of the prostate or subjects with known history of serum PSA concentration greater than 4 ng/ml (must have prostate cancer ruled out to the satisfaction of the investigators).
2. Subjects with a residual void volume of greater than 150 mL.
3. Subjects with maximum urine flow rate of less than 5 mL/sec.
4. Subjects with uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 100 mmHg).
5. Subjects with uncontrolled diabetes (fasting blood sugar level greater than 130 mg/dL).
6. Subjects who report consuming alcoholic beverages or active nicotine consumption (smoking cigarettes, vaping / ecigarettes, chewing tobacco, snuff, etc.) within the last 30 days as evidenced by self reporting.
7. Subjects with BMI greater than or equal to 35kg/m2.
8. Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal / liver and biliary tract, kidney and urinary, nervous,
9. Subjects with history of neurogenic bladder dysfunction or bladder cancer.
10. Subjects with acute or chronic prostatitis, urinary tract infection, hematuria, diabetes or any other chronic illness, which in the opinion of the investigator would warrant exclusion from the study or prevent the subject from completing the study.
11. Subjects with bladder neck contracture or urethral stricture.
12. Subjects with any serious medical comorbidity.
13. Subjects with history of any prior surgery which could induce dysuria.
14. Subjects using any other herbal medications for treatment of BPH and/or and associated symptoms.
15. Subjects with erectile dysfunction in the past 1 month.
16. Subjects with history of alcoholism or drug abuse.
17. Subjects who are on 5alpha reductase inhibitors, alpha blockers, anticholinergics, antidiuretic hormones, antimuscarinics, or any other herbal medications (including health functional foods) for treatment of BPH and associated symptoms within 12 weeks of visit 1.
18. Subjects who are on testosterone replacement therapy (TRT) including testosterone undecanoate, testosterone enanthate, testosterone cypionate, testosterone ester, phoshodiestearase 5 (PDE 5) inhibitors, LH RH analogs, statins, fibrates, niacin, steroid, fish oil, colistin, fiber based laxatives, phytosterol margarines, anti diabetic agents, antiplatelet agents, thyroxine, diuretics, beta-blockers, any other anti-androgenic agents, treatment for erectile dysfunction (ED), or any other herbal medications (including health functional foods) for treatment of male menopause and associated symptoms within 12 weeks of visit 1.
19. Subjects who are allergic to herbal products or any component(s) of the study products.
20. Subjects who are known to be HIV or hepatitis B positive or known to have any other immune compromised state.
21. Subjects who are currently participating or having participated in any other clinical trial during the past 3 months prior to the beginning of this study.
22. Any additional condition(s) that in the opinion of the investigators would warrant exclusion from the study or prevent the subject from completing the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the following parameters from baseline to end of treatment
1. Post-void residual volume of urine
2. IPSS score
3. Uroflowmetry parameters:
Maximum urine flow rate
Average urine flow rate
Time to maximum flow rate
Delay time (hesitancy)
|
1. Post-void residual volume of urine --- Day 0 and Day 84
2. IPSS score - Day 0,Day 42 and Day 84
3. Uroflowmetry parameters Day 0 and Day 84
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the following parameters from baseline to end of treatment
1. ADAM questionnaire score
2. AMS score
3. Quality of life score
4. Laboratory parameters
Prostate specific antigen (PSA)
17 beta-hydroxysteroid dehydrogenase (17 beta HSD)
3 beta-hydroxysteroid dehydrogenase (3 beta HSD)
5 alpha-reductase
Testosterone & free testosterone
Serum creatinine
Blood urea nitrogen
CBC
AST & ALT
Urine analysis
Basic hematology & biochemistry parameters
5. Safety (incidence of adverse events) assessment
|
1. ADAM questionnaire score-- Day 0,Day 42 & Day 84
2. AMS score - Day 0,Day 42 & Day 84
3. Quality of life score - Day 0,Day 42 & Day 84
4. Laboratory parameters & urine analysis: Day 0 & day 84
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
29/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
As lower urinary tract symptoms
and benign prostatic hyperplasia (BPH) prevalence increase with age, Fenugreek
seed extract presents a potential solution for both age-related androgen
decline and BPH. TRT exacerbates BPH symptoms, whereas Fenugreek seed extract,
by releasing bound testosterone and potentially inhibiting the conversion of
testosterone to dihydrotestosterone, may offer relief to aging males affected
by both conditions.[59,64]
Understanding the dual
challenges of declining testosterone and increasing BPH prevalence among older
men suggests a promising role for Fenugreek seed extract as a potential single
treatment addressing both conditions. Research demonstrates its efficacy in
addressing age-related androgen decline and suggests a possible protective role
against prostate growth.
The present study is designed to confirm the efficacy
and safety of Fenugreek seed extract in subjects with benign prostate
hyperplasia and male menopause individuals with the study title—“ A randomized,
double-blind, placebo-controlled, parallel-group, single center clinical study
to evaluate the efficacy and safety of fenugreek extract in comparison with
placebo in men with lower urinary tract symptoms and male menopausal symptoms
|