Safety and efficacy of LipidUp-PE in the management of premature ejaculation.
- Conditions
- Other male erectile dysfunction. Ayurveda Condition: Premature Ejaculation,
- Registration Number
- CTRI/2021/10/037471
- Lead Sponsor
- MMC Pharmaceuticals Ltd
- Brief Summary
Premature ejaculation (PE) is one of the most frequent male sexual complaints. It is estimated that 20% to 30% of men experience PE at some point in their lifetime. Treatments for PE mainly include drug therapy and psychological and behavioral therapy. Oral 5-HT receptor reuptake inhibitors (SSRIs) are well-established and effective therapies for the treatment of PE, including fluoxetine, paroxetine, sertraline, dapoxetine, and so on. However, the side effects of SSRIs, such as nausea, vomiting, and dry mouth are somewhat confusing for clinicians. At the same time, evidence shows that the efficacy of psychological and behavioral therapy is also not clear.
LibidUP-PE is a nutraceutical for sexual well-being. L-arginine and GSE can provide strength and vigor needed in ED. In those with diminished libido, the sexual desires can be heightened by Safedmusli. The combined might of inositol supplementation, L-trptophan and vitamin B6 normalizes the ejaculatory process and emission of semen.The present study was designed to evaluate the safety and efficacy of LibidUP-PE inthe management of premature ejaculation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
- Subjects meeting with diagnostic criteria for Premature Ejaculation (PE score greater than or equal to 11).
- Subjects must be in a stable, monogamous, sexual relationship with the same partner for at least 6 months and plan to maintain this relationship for the duration of the trial.
- Subjects with intravaginal ejaculatory latency time (IELT) of ≤ 2 minutes.
- Subjects who are willing to sign informed consent for participation in the study.
- Subjects with genital anatomical deformities including but not limited to penile deformities.
- Use of any investigational drug within the past month Subjects with major psychiatric illness or previous suicidal attempts.
- Subjects with history of epilepsy Subjects with alcohol abuse, dependence, smoking addiction, and on any other drugs which can interfere with ejaculation can be excluded Subjects with significant and uncontrolled hematological /metabolic/ endocrinologial/ respiratory/ cardiovascular/ neurological/psychiatric/liver/ gastrointestinal/kidney diseases or other significant pathological conditions which is judged by Investigator may affect subject participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of LipidUp-PE on Serotonin (5-hydroxytryptamine, 5-HT) in subjects with premature ejaculation. First response rate can be measured at 1st week | from the day of the therapy for 4 weeks
- Secondary Outcome Measures
Name Time Method To assess the effect of LipidUp-PE on IntravaginalEjaculatory Latency Time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) scores in subjects with premature ejaculation. At Initial and after 12th Week
Trial Locations
- Locations (1)
SRM Medical College Hospital & Research Centre,
🇮🇳Kancheepuram, TAMIL NADU, India
SRM Medical College Hospital & Research Centre,🇮🇳Kancheepuram, TAMIL NADU, IndiaDr TM VijayakumarPrincipal investigator9003400350vijaypractice@yahoo.com