Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men

Recruitment & Eligibility

Status: Not yet recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: 1. Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED 2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3. Participant having baseline IELT of less than 2 min 4. Participants meeting with diagnostic criteria for PEP score greater than or equal to 11 5. 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 6. Participants should be in an active stable sexual relationship only married participants for the entire duration of the study 7. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form. Exclusion Criteria: 1. Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery 2. Participants with genital anatomical deformities, including but not limited to penile deformities 3. Participants for whom sexual activity is inadvisable because of their underlying disease status 4. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals 5. 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 6. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs; 7. Participants with history or presence of significant alcoholism or drug abuse within the past 1 year 8. 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 9. Any concomitant treatment that is not permissible including but not limited to (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc). 10. Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol 11. Known hypersensitivity to any of the ingredients of investigational product 12. 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 13. 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale;Premature ejaculation assessed using Premature Ejaculation Profile (PEP) Questionnaire;Sexual stamina assessed using intravaginal ejaculatory latency time (IELT);libido system score (LSS);Changes in serum testosterone;Changes in Lactate dehydrogenase(LDH);Body Mass Index (BMI);COPE Questionnaire;Assessment of Maximum oxygen consumption;Assessment of % fat using bioelectrical impedance analysis (BIA);Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA);Handgrip strength;STAI (State-Trait Anxiety Inventory);Profile of Mood State (POMS) questionnaire;Intimacy problems;Assessment of blood flow

Secondary Outcome Measures

Name	Time	Method
Safety of participant Assessed using adverse events;Safety of participant Assessed using treatment compliance and tolerability of investigational product;Systolic blood pressure difference from reference measurement (mmHg);Diastolic blood pressure difference from reference measurement (mmHg);Pulse rate difference from reference measurement (beats per minute);Complete blood count;Serum Glutamic Pyruvic Transaminase (SGPT);Serum glutamic-oxaloacetic transaminase (SGOT);Creatinine difference from reference measurement (mg/dl)