| CTRI Number |
CTRI/2024/03/064755 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the effect of TLF-20 on Middle Aged Men with Low Testosterone. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Comparative Evaluation of TLF-20 on Relevant Sexual Biomarkers in Middle Aged Men with Low Testosterone. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-AK-131 Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank S Gowda |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of General Medicine, Room No.3, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drshashank.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research,
No.9, 1st Floor, Mythri Legacy, Cehlekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research,
No.9, 1st Floor, Mythri Legacy, Cehlekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O Ernakulam, Kerala 683561, India |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt. Ltd |
| Address |
Malaidamthuruthu P.O Ernakulam, Kerala 683561, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Shashank S Gowda |
BGS Global Institute of Medical Sciences |
Department of General Medicine, Room No. 3, Research Ward, No.67,BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA |
9741073960
drshashank.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutioanal Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E348||Other specified endocrine disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo 500mg |
Oral Administration of 500 mg Placebo capsule once a day for 84 days |
| Intervention |
TLF-20 100mg |
Oral Administration of 100 mg TLF-20 capsule once a day for 84 days |
| Intervention |
TLF-20 500mg |
Oral Administration of 500 mg TLF-20 capsule once a day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Subjects with morning total testosterone level less than 300 ng/dL
2. Subject with androgen deficiency symptoms assessed by Androgen Deficiency in Aging Male
(ADAM) questionnaire items 1 or 7 or any 3 other questions as positive
3. Subjects with Basal Metabolic Index (BMI) greather than 25 Kg per m2
4. Subjects with no history of surgical or medical castration, diagnosed erectile dysfunction or
any physical disability that may limit sexual function
5. Non-smoker
6. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of Uncontrolled diabetes and hypertension, Diagnosable mental health disorder e.g., depression, anxiety disorder, eating disorder, psychosis/ schizophrenia,Cancer, thyroid diseases, liver and gall bladder diseases, renal failure, chronic fatigue syndrome, asthma, cardiovascular disorders,Subjects diagnosed with prostate cancer or benign prostatic hypertrophy, had an acute genitourinary disorder or history of genital surgery, Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy that contributes to symptoms of low energy or fatigue, Any recent major stressful episodes like surgery, accidents, death in family etc
2. Subjects who has been administered any PDE-V inhibitors (sildenafil, tadalafil, or vardenafil) and chemotherapy, corticosteroid, anticoagulation, testosterone, antiandrogen medication within the four weeks prior to enrollment and during the entire course of the study
3. Subjects undergone any treatment/ therapy for any sexual disorder during last 6 months
4. Subjects having symptoms of viral infection
5. Subjects with known hypersensitivity to Ashwagandha extract
6. History of smoking, alcohol/drug abuse
7. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
8. History of clinically significant illness or any other medical disorder or any disabilities that significantly affect the data collected, such as severe deafness or blindness that may interfere with subject treatment, assessment or compliance with the protocol.
9. Any additional condition(s) that in the Investigators opinion 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
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the TLF-20 compared to placebo on free testosterone, total testosterone, bioavailable testosterone, sex hormone binding globulin (SHBG), albumin, estradiol (E2), Dehydroepiandrosterone sulfate (DHEA-S) levels. |
Day 0, Day 28, Day 56, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and efficacy of TLF-20 |
Day 0, Day 28, Day 56, 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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a randomized (1:1:1), double-blind,
active-controlled clinical study. Subjects meeting all inclusion and no
exclusion criteria will sign a written informed consent and will be enrolled in
the study. After passing the eligibility criteria, subjects will be randomized into Placebo, 500mg of TLF-20, and 100mg of TLF-20,
respectively for 12 weeks. All assessments will be performed for Baseline, Day 28, Day 56 and Day 84. Blood samples will be collected for safety and biomarker analysis. |