Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
NCT Number: NCT06571318
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature Ejaculation|Stress
Interventions: OTHER: Destress and Perform Capsule-U001|OTHER: Destress and Perform Capsule-I001|OTHER: Placebo capsules 002
Sponsor: Herbolab India Pvt. Ltd.
Sex: MALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-05
Completion Date: 2024-12-28

Summary:
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.

Primary Outcome Measures: 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., Screening, day 30 and day 60|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., Screening, day 30 and day 60|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, Screening, day 30 and day 60|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., Screening, day 30 and day 60|Changes in serum testosterone, The testosterone secretion will be evaluated by measuring serum testosterone levels, Screening, day 30 and day 60|Changes in Lactate dehydrogenase(LDH), Blood level Lactate dehydrogenase was measured. (U/L), Screening, day 30 and day 60|Body Mass Index (BMI), Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches' x Height in inches)) x 703, Screening, day 30 and day 60|COPE Questionnaire, Problem-Focused Coping: A high score indicates coping strategies that are aimed at changing the stressful situation. High scores are indicative of psychological strength, grit, a practical approach to problem solving and is predictive of positive outcomes.

Emotion-Focused Coping: A high score indicates coping strategies that are aiming to regulate emotions associated with the stressful situation. High or low scores are not uniformly associated with psychological health or ill health, but can be used to inform a wider formulation of the respondent's coping styles.

Avoidant Coping: A high score indicates physical or cognitive efforts to disengage from the stressor. Low scores are typically indicative of adaptive coping., Screening, day 30 and day 60|Assessment of Maximum oxygen consumption, Maximum oxygen consumption (VO2 max) should be calculated by the following equation:

VO2 max (mL/kg/min) = 111.33 - (0.42 × heart rate (bpm)), Screening, day 30 and day 60|Assessment of % fat using bioelectrical impedance analysis (BIA), It is calculated in terms of percentage, Screening, day 30 and day 60|Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA), It is calculated in terms of percentage., Screening, day 30 and day 60|Handgrip strength, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in Kilogram force., Screening, day 30 and day 60|STAI (State-Trait Anxiety Inventory), STAI: State-Trait-Anxiety-Inventory-Score This test consists of 20 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety).

The sum score has a range from 20-80. Its interpretation with respective score are discussed below:

mild anxiety (20 to 39); moderate anxiety (40 to 59); intense anxiety (60 to 80)., Screening and day 60|Profile of Mood State (POMS) questionnaire, The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 40 item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "Extremely". Higher score indicates worse mood. Total POMS score categories and stress inference:0-40 = A little; 81-120= Quite a lot; 41-80= Moderately; 121-160= Extremely., Screening and day 60|Intimacy problems, Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory., Screening and day 60|Assessment of blood flow, Assessment of blood flow using penile Doppler-

1. Peak systolic velocity of the CA (cavernosal artery) - Indicator of arterial influx: Normal: \>35 cm/sec, Gray zone: 25-35 cm/sec Abnormal.
2. End diastolic velocity of the CA - Normal: 5 cm/sec, Diastolic flow reversal: reliable indicator of intact veno-occlusive mechanism.
3. Deep dorsal vein - Normal: 20 cm/sec, Moderate increase: 10-20 cm/sec, Marked increase: \>20 cm/sec
4. Arterial compliance of the CA - 60%-75% increase in diameter Ø Evident pulsation
5. Resistive index of the CA - Normal: \>0.9, Venous leak: \<0.75, Screening and day 60
Secondary Outcome Measures: Safety of participant Assessed using adverse events, It is measure in terms of No. of events, Screening, baseline, day 30, day 60|Safety of participant Assessed using treatment compliance and tolerability of investigational product, It is measure in terms of percentage, Screening, baseline, day 30, day 60|Systolic blood pressure difference from reference measurement (mmHg), Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg), Screening, baseline, day 30, day 60|Diastolic blood pressure difference from reference measurement (mmHg), Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg), Screening, baseline, day 30, day 60|Pulse rate difference from reference measurement (beats per minute), Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute), Screening, baseline, day 30, day 60|Complete blood count, White blood cell and platelet count \[Thousand per microliter (Thousand/uL)\] Red blood cell count \[Millions per microliter (million/uL)\], Screening and day 60|Serum Glutamic Pyruvic Transaminase (SGPT), Blood level of SGPT was measured. (U/L), Screening and day 60|Serum glutamic-oxaloacetic transaminase (SGOT), Blood level of SGOT was measured. (U/L), Screening and day 60|Creatinine difference from reference measurement (mg/dl), Blood levels of Creatinine was measured. (mg/dl), Screening and day 60