| CTRI Number |
CTRI/2021/10/037471 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety and efficacy of LipidUp-PE in the management of premature ejaculation. |
|
Scientific Title of Study
|
Safety and efficacy of LibidUp-PE on premature ejaculation: A randomized placebo controlled double blind crossover study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayakumar |
| Designation |
Associate Professor and Head |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice
SRM College of Pharmacy
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Urology
SRM Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
srinivasan.thimmaraju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RC Satish Kumar |
| Designation |
Associate Professor and coordinator |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Interdisciplinary Institute of Indian System of Medicine
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
ayursatish@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
MMC Pharmaceuticals Ltd |
| Address |
113 Visalakshi Street
Devi Karumariamman Nagar
Valasaravakkam,
Chennai 600087 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM Medical College Hospital and Research Centre |
SRM Nagar,
Kattankulathur-603203
Chengalpattu District
Tamil Nadu |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr TM Vijayakumar |
SRM Medical College Hospital & Research Centre, |
Room No. 401, Department of Urology,
SRM Medical College Hospital and Research Centre,
SRMIST, Kattankulathur-603203
Kancheepuram
TAMIL NADU |
9003400350
vijaypractice@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N528||Other male erectile dysfunction. Ayurveda Condition: Premature Ejaculation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LipidUp-PE |
Daily 2 sachets mix in 200ml of water |
| Comparator Agent |
Placebo |
Daily 2 sachets mix in 200ml of water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/10/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |