An interventional study of Destress and Perform Capsule-U001 and Destress and Perform Capsule-I001 in Premature Ejaculation and Stress, sponsored by Herbolab India Pvt. Ltd.. Not yet recruiting. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Herbolab India Pvt. Ltd. · Not applicable, Interventional, and Supportive care
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.
This will be a randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Perform Capsule in the management of stress-induced premature ejaculation in healthy adult men.
More than 60 participants will be randomized into three groups: Group A: De-Stress and Perform Capsule-U001 (20 participants), Group B: De-Stress and Perform Capsule-I001 (20 participants), Group C: Placebo Capsule-002 (20 participants) in a 1:1:1 ratio. The treatment duration will be 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed at screening.
The efficacy of the intervention will be assessed by evaluating the following: changes in Perceived Stress Scale (PSS) score; changes in Premature Ejaculation Profile (PEP) score, including PEP control, PEP satisfaction, PEP distress, PEP relationship problems, and PEP Index Score; changes in sexual stamina using Intravaginal Ejaculatory Latency Time (IELT) score; changes in Libido System Score (LSS) score; changes in levels of serum testosterone, cortisol, and LDH; changes in weight and BMI; changes in COPE Questionnaire scores, including Positive Subscale and Denial Subscale; changes in % fat and % skeletal muscle using Bioelectrical Impedance Analysis (BIA); and changes in handgrip strength using a hand-held dynamometer, assessed at screening, day 30, and day 60.
Additionally, changes in blood flow will be assessed by penile Doppler in erectile dysfunction (ED) participants (a subset of 15 participants, i.e., 5 participants from each group). Changes in State-Trait Anxiety Inventory (STAI) score; changes in Profile of Mood States (POMS) questionnaire scores, including Total Mood Disturbance and Depression; changes in cardiorespiratory endurance (maximal oxygen uptake VO2 max) by steps test; and changes in Personal Assessment of Intimacy in Relationships (PAIR) scores (to be completed by partner) will also be evaluated at screening and day 60.
Treatment compliance and tolerability of investigational products will be assessed at day 30 and day 60. Safety of the investigational treatment in terms of adverse events (AEs) and serious adverse events (SAEs) will be assessed at baseline, day 30, and day 60. Assessments of changes in vital sign parameters will be done thought the visit. Assessments of changes in complete blood count, liver function test, and kidney function test will be done at screening and day 60.
Exclusion Criteria:
Other: Destress and Perform Capsule-U001
Other: Destress and Perform Capsule-I001
Other: Placebo capsules 002
Two Capsules in sequence daily after meal for 60 days.
Two Capsules in sequence daily after meal for 60 days.
Two Capsules in sequence daily after meal for 60 days
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 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.
Time frame: 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
Time frame: 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.
Time frame: Screening, day 30 and day 60
Changes in serum testosterone
The testosterone secretion will be evaluated by measuring serum testosterone levels
Time frame: Screening, day 30 and day 60
Changes in Lactate dehydrogenase(LDH)
Blood level Lactate dehydrogenase was measured. (U/L)
Time frame: 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
Time frame: 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.
Time frame: 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))
Time frame: Screening, day 30 and day 60
Assessment of % fat using bioelectrical impedance analysis (BIA)
It is calculated in terms of percentage
Time frame: Screening, day 30 and day 60
Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA)
It is calculated in terms of percentage.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Screening and day 60
Intimacy problems
Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.
Time frame: 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
Time frame: Screening and day 60
Safety of participant Assessed using adverse events
It is measure in terms of No. of events
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Screening, baseline, day 30, day 60
Complete blood count
White blood cell and platelet count \[Thousand per microliter (Thousand/uL)\] Red blood cell count \[Millions per microliter (million/uL)\]
Time frame: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Blood level of SGPT was measured. (U/L)
Time frame: Screening and day 60
Serum glutamic-oxaloacetic transaminase (SGOT)
Blood level of SGOT was measured. (U/L)
Time frame: Screening and day 60
Creatinine difference from reference measurement (mg/dl)
Blood levels of Creatinine was measured. (mg/dl)
Time frame: Screening and day 60
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Herbolab India Pvt. Ltd.