A randomized, double-blind, multicenter, placebo-controlled clinical study to evaluate the safety and efficacy of TruBlk™ Shilajit Resin in improving sexual health in males.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amaara Ayurveda
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- i. Change in total testosterone, free testosterone and cortisol levels (Baseline and Day 90)
Overview
Brief Summary
This is a randomized, double-blind, multicenter, placebo-controlled clinical study designed to evaluate the safety and efficacy of TruBlk™ Shilajit Resin in improving sexual health in males. A total of 100 male participants aged 35 to 55 years, with a BMI less than or equal to 30 and mild to moderate erectile dysfunction, will be enrolled. Participants will be randomized in a 1:1 ratio into two groups: one receiving 250 mg of TruBlk™ Shilajit Resin twice daily, and the other receiving a matching placebo for 90 days.
The primary objective is to assess changes in total testosterone, free testosterone, cortisol, nitric oxide levels, libido, and sexual stamina. Secondary objectives include evaluating the effects on energy, mood, stress, fatigue, and overall well-being, along with safety assessments. Efficacy assessments will be conducted using standardized tools like the International Index of Erectile Function (IIEF) and the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q). Fatigue will be assessed using the Fatigue Severity Scale (FSS), and an exploratory semen analysis will be conducted.
Safety will be monitored through adverse event reporting, vital signs, treatment compliance, and tolerability at scheduled visits. The study follows ICH-GCP guidelines to ensure the safety and integrity of participants and data.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Male participants aged 35 to 55 years with BMI less than or equal to 30 kg per m
- •Participants who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
- •Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit.
- •Participants should be in an active stable sexual relationship (only married participants) for the entire duration of the study.
- •Participants willing to participate in clinical study and who have read understood and signed the informed consent form.
Exclusion Criteria
- •Previous events or other severe conditions that may affect sexual health or metabolic health.
- •Participants with genital anatomical deformities, including but not limited to penile deformities.
- •Participants for whom sexual activity is inadvisable because of their underlying disease status.
- •Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals.
- •Participants with any significant comorbid condition or currently undergoing pharmacological treatment, which in the investigators judgment may interfere with the clinical study outcomes.
- •Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.
- •Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year.
- •Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day.
- •Any concomitant treatment that is not permissible including but not limited to nitrates, anti androgens, chemotherapy agents, radiotherapy, etc.
- •Recent participation in another clinical study or receiving some other drug during the study besides that in the protocol.
Outcomes
Primary Outcomes
i. Change in total testosterone, free testosterone and cortisol levels (Baseline and Day 90)
Time Frame: i. Baseline and Day 90 | ii. Screening, Day 30, Day 60 and Day 90 | iii. Baseline, Day 30, Day 60 and Day 90.
ii. Change in IIEF score (Erectile function, orgasmic function, sexual desire, satisfaction with intercourse, overall satisfaction) at Screening, Day 30, Day 60 and Day 90
Time Frame: i. Baseline and Day 90 | ii. Screening, Day 30, Day 60 and Day 90 | iii. Baseline, Day 30, Day 60 and Day 90.
iii. Change in Hypogonadism Impact of Symptoms Questionnaire (HIS Q) a validated patient reported outcome tool designed to assess symptom severity and impact on quality of life domains at Baseline, Day 30, Day 60 and Day 90.
Time Frame: i. Baseline and Day 90 | ii. Screening, Day 30, Day 60 and Day 90 | iii. Baseline, Day 30, Day 60 and Day 90.
Secondary Outcomes
- 1. Changes in severity & impact of fatigue on daily functioning through Fatigue Severity Score (FSS) at Baseline, day 30, day 60 & day 90.(2. Changes in the participant & investigator global assessment score at Baseline & Day 90.)
Investigators
Dr Utsa Basu
Dr. Utsa Basus Clinic