Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men

NCT06571318 | Not Yet Recruiting DMC

• 2 other identifiers: MHC/CT/24-25/018CTRI/2024/07/071256
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Premature Ejaculation; Stress

Keywords

Premature Ejaculation; Stress

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (9)

• Safety of participant Assessed using adverse events

  Screening, baseline, day 30, day 60

• Safety of participant Assessed using treatment compliance and tolerability of investigational product

  Screening, baseline, day 30, day 60

• Systolic blood pressure difference from reference measurement (mmHg)

  Screening, baseline, day 30, day 60

• Diastolic blood pressure difference from reference measurement (mmHg)

  Screening, baseline, day 30, day 60

• Pulse rate difference from reference measurement (beats per minute)

  Screening, baseline, day 30, day 60

Study Arms (3)

Destress and Perform Capsule-U001

EXPERIMENTAL

Other: Destress and Perform Capsule-U001

Destress and Perform Capsule-I001

EXPERIMENTAL

Other: Destress and Perform Capsule-I001

Placebo capsules 002

OTHER

Other: Placebo capsules 002

Interventions

Destress and Perform Capsule-U001 OTHER

Two Capsules in sequence daily after meal for 60 days.

Destress and Perform Capsule-U001

Destress and Perform Capsule-I001 OTHER

Two Capsules in sequence daily after meal for 60 days.

Destress and Perform Capsule-I001

Placebo capsules 002 OTHER

Two Capsules in sequence daily after meal for 60 days

Placebo capsules 002

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group
• 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 trials and who have read understood and signed the informed consent form.

You may not qualify if:

• 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
• Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
• Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs;
• Participants with history or presence of significant alcoholism or drug abuse within the past 1 year
• Participants with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/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 trial or receiving some other drug during the study besides that in the protocol
• Known hypersensitivity to any of the ingredients of investigational product
• Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceutical, or ayurvedic supplement for stress and/or PE management
• Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

Sponsors & Collaborators

• Herbolab India Pvt. Ltd.: lead

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Dr. Ramshyam Agarwal, MBBS, DNB

  Lokmanya Medical Research Centre and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Kriti Soni, PhD

CONTACT

+91 9871018383; kriti.soni@rpsg.in

Dr. Gayatri Ganu, PhD

CONTACT

+91 8554912644; drgayatri@mprex.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double blind, Parallel Group, Placebo Controlled Trial

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 26, 2024
• Study Start: September 5, 2024
• Primary Completion: November 20, 2024
• Study Completion: December 28, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share