Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21-50
SponsorHerbolab India Pvt. Ltd.
About this trial
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED
Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
Participant having baseline IELT of less than 2 min
Participants meeting with diagnostic criteria for PEP score greater than or equal to 11
Disqualifiers
Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
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
Trial design
Design model
Parallel
Treatments tested in this trial
Destress and Perform Capsule-U001
Other interventionTwo Capsules in sequence daily after meal for 60 days.
Destress and Perform Capsule-I001
Other interventionTwo Capsules in sequence daily after meal for 60 days.
Placebo capsules 002
Other interventionTwo Capsules in sequence daily after meal for 60 days
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Destress and Perform Capsule-U001Experimental treatment 1 intervention
Group B: Destress and Perform Capsule-I001Experimental treatment 1 intervention
Group C: Placebo capsules 002Other 1 intervention
Trial outcomes
Primary outcomes
1
Perceived Stress Scale
The PSS-10 is widely used for measuring psychological distress. It contains 10 questions on a five-point scale from 0 to 4. The higher the score, the greater the feeling of stress. PSS-10 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Time frame
Screening, day 30 and day 602
Premature ejaculation assessed using Premature Ejaculation Profile (PEP) Questionnaire
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Time frame
Screening, day 30 and day 603
Sexual stamina assessed using intravaginal ejaculatory latency time (IELT)
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Greater the time duration greater will be the sexual stamina
Time frame
Screening, day 30 and day 604
libido system score (LSS)
The Stamina Libido System Score (Often Abbreviated as SLS Score) is a Metric used to assess various aspects of Sexual health, stamina, and libido. Scoring system aims to Total Score Interpretation 0-2: loss of libido; 3-4: low libido; 5-7: good libido, and 8-12: high libido.
Time frame
Screening, day 30 and day 60Secondary outcomes
1
Safety of participant Assessed using adverse events
It is measure in terms of No. of events
Time frame
Screening, baseline, day 30, day 602
Safety of participant Assessed using treatment compliance and tolerability of investigational product
It is measure in terms of percentage
Time frame
Screening, baseline, day 30, day 603
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame
Screening, baseline, day 30, day 604
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame
Screening, baseline, day 30, day 60Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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