CTRI/2024/10/075195 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On:
24/10/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Nutraceutical
Study Design
Randomized, Crossover Trial
Public Title of Study
Evaluating the Efficacy and Safety of Testosurge Capsules for Hormonal Balance in Healthy Adult Males: A Double-Blind, Placebo-Controlled Study
Scientific Title of Study
Efficacy and safety of Testosurge capsules for hormonal balance including total testosterone level increase (LC-MS method) in healthy, adult males: A randomized, double-blind, placebo-controlled, crossover, confirmatory study.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
Testosurge-Subacute-Male
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Shailender Singh Tanwar
Designation
Principal Investigator
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I
1, Rahul Residency, Salunkhe Vihar Road, Kondhwa, Pune-411048, Maharashtra, India
Type of Sponsor
Other [Nutraceutical Industry - Indian]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Yogesh Popalghat MBBS
BioRadius Therapeutic Research Pvt. Ltd.
IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I Pune MAHARASHTRA
09892023392
dryogeshpopalghat@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Skinovate Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Not Applicable
Intervention / Comparator Agent
Type
Name
Details
Intervention
Active: Testosurge 500 mg capsules
500 mg a capsule once daily in the evening around 08.00 pm., before a meal for 07 days during Period 1 and Period 2.
Comparator Agent
Placebo: Matching placebo 500 mg capsules (containing all excipients except active ingredient)
500 mg a capsule once daily in the evening around 08.00 pm., before a meal for 07 days during Period 1 and Period 2.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
Healthy adult male volunteers aged 18 to 45 years (inclusive) with a weight of at least 50 kg and a Body Mass Index (BMI) between 18.50 and 30.00 kg/m² (inclusive). Volunteers must provide adequate evidence of their identity and demonstrate the capability and willingness to give informed written consent and adhere to study requirements. Participants must be assessed as healthy based on personal and medical history, general medical examination, and absence of significant disease as judged by the Principal Investigator (PI). Volunteers must have normal laboratory parameters (hematology, biochemistry, and serology) or have abnormalities deemed clinically insignificant, with tests conducted within 21 days prior to check-in for Period 1, as judged by the PI. Participants must test negative on a urine screen for drugs of abuse, including cannabinoids (CANNAB/Tetrahydrocannabinol-THC), amphetamines (AMP), barbiturates (BAR), cocaine (COC), benzodiazepines (BZO), and opioids (MOR/OPI). A negative breath alcohol test is required. Volunteers must be willing to use highly effective contraception consistently and correctly throughout the duration of the study.
ExclusionCriteria
Details
History or presence of significant hematopoietic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological conditions, urinary retention, severe gastrointestinal disorders, dysphasia, myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia, psychiatric diseases or disorders, diabetes mellitus, tuberculosis, systemic hypertension, or any medical disorder deemed significant by the Principal Investigator (PI).
History of any major surgical procedure, depot injections or drug implants in the past 3 months, or a history of dialysis.
History or presence of any medication for joint pain, inflammation, or kidney/urinary tract stones.
Recent history of dehydration due to diarrhea, vomiting, or any other cause within 24 hours prior to check-in.
History or presence of cancer.
Difficulty in donating blood, personal or family history of muscular disorders, or any deformity affecting venous access for cannulation.
Consumption of alcohol within 48 hours prior to check-in Day 01 or difficulty abstaining from alcohol during the study.
Consumption of caffeine and/or xanthine products (e.g., coffee, tea, chocolate, caffeine-containing sodas) within 24 hours prior to check-in Day 01 for each period.
Consumption of tobacco products and grapefruit or its juices within 48 hours prior to check-in for Period 1.
History of allergies to vegetables and/or food substances or any manifestations suggestive of hypersensitivity reactions.
Present or past use of medications that potentially modify the kinetics/dynamics of the study medications, or any other medication deemed clinically significant by the PI.
Positive screening test result for any of the following: HIV, Hepatitis B, Hepatitis C, or VDRL.
Intake of over-the-counter products, herbal medications, etc., within 7 days prior to check-in Day 01 for each period.
Following an unusual diet (e.g., low sodium) for three weeks prior to check-in.
History of hypersensitivity to study medications or related excipients in the formulation.
History or presence of male sexual dysfunction and use of any medication within the last 30 days that may affect male sex hormones.
Intake of supplements containing fenugreek.
Intake of any natural or synthetic testosterone-boosting supplements.
Any condition that, in the PI’s opinion, makes the subject unsuitable for inclusion.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of Testosurge capsules on TT (ng/dL) levels by LC-MS
00.00 h (8:00 pm), 03.00 h (11:00 pm), 07.00 h (3:00 am), 10.00 h (6:00 am), 12.00 h (8:00 am), 15.00 h (11:00 am), 19.00 h (03:00 pm) and 22.00 h (06:00 pm) hours (± 15 minutes) after administration of IP on Day 01 and Day 07 in each period
Secondary Outcome
Outcome
TimePoints
To evaluate the efficacy of Testosurge capsules on serum SHBG (nmol/L) by Enzyme-linked immunosorbent assay (ELISA)
00.00 h (8:00 pm), 03.00 h (11:00 pm), 07.00 h (3:00 am), 10.00 h (6:00 am), 12.00 h (8:00 am), 15.00 h (11:00 am), 19.00 h (03:00 pm) and 22.00 h (06:00 pm) hours (± 15 minutes) after administration of IP on Day 01 and Day 07 in each period
To evaluate the efficacy of Testosurge capsules on the
following parameters-
• cFT (calculation) (ng/dL)
• BT (calculation) (ng/dL)
• Serum Albumin by Bromocresol Green method (g/dL)
• Serum DHT by ELISA method (pg/ml)
• Serum Estradiol by Chemiluminescence immunoassay (CLIA) (pg/ml)
• Fasting Plasma Glucose by Colorimetry (mg/dL)
• Fasting Serum Insulin by CLIA (microU/ml)
• Plasma NAD+ by ELISA (ng/ml)
• Plasma ATP by ELISA (ng/mL)
12.00 hour (08:00 AM) (± 15 minutes) (fasting blood samples) on day 02 and day 08 in each period.
Target Sample Size
Total Sample Size="46" Sample Size from India="46" 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
N/A
Date of First Enrollment (India)
01/11/2024
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="2" 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
Title: Efficacy and safety of Testosurge capsules for hormonal balance including total testosterone level increase (LC-MS method) in healthy, adult males: A randomized, double-blind, placebo-controlled, crossover, confirmatory study.
In a previous clinical study on Testosurge in sedentary young males (Mokashi, Singh-Mokashi et al. 2014), Testosurge capsules at a single dose of 600 mg showed a significant increase in serum measured free testosterone (mFT), calculated free testosterone (cFT), bioavailable testosterone (BT), and total testosterone (TT), were well tolerated and showed an excellent safety profile, with no adverse events during the study.
Testosurge 500 mg, once a day has been reported to improve male hormonal profiles (serum TT and BT levels) in resistance-trained men with excellent safety profile for 8 weeks (Wilborn, Taylor et al. 2010).
Duration: Total of 30 days, with two 7-day periods separated by a 15-day washout.
Sample Size: 46 healthy adult males aged 18-45.
Eligibility Criteria:
Inclusion: Healthy males within specified age and weight ranges, able to provide informed consent.
Exclusion: Significant medical history, recent drug use, alcohol or caffeine consumption prior to study, and other specific conditions.
Study Site: BioRadius Therapeutic Research Pvt. Ltd., Pune, India.
Key Outcomes:
Primary Efficacy: Measurement of TT levels at specified time points.
Safety Outcomes: Monitoring vital signs and laboratory parameters pre- and post-study.
Statistical Analysis: Descriptive statistics for baseline characteristics and comparisons of efficacy and safety outcomes across treatment groups.
Ethics and Monitoring: The study will adhere to international guidelines and regulatory requirements, with ethics committee approval and ongoing sponsor monitoring to ensure data integrity. This study seeks to further validate the efficacy of Testosurge in promoting hormonal balance in a controlled, scientifically rigorous setting.