| CTRI Number |
CTRI/2017/08/009226 [Registered on: 02/08/2017] Trial Registered Prospectively |
| Last Modified On: |
01/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
OLNP-05 for the treatment of premature ejacuation |
|
Scientific Title of Study
|
A randomized, double blind, placebo control study to assess the efficacy and safety of OLNP-05 capsule versus placebo for the treatment of subjects with premature ejacuation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OLS/NUM/03/17 Version 01, Dated 22 Mar 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Sanjib panda |
| Designation |
Head Operation |
| Affiliation |
Ocius Life Sciences Private Limited |
| Address |
No.325, P.H road, Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9003580729 |
| Fax |
|
| Email |
sanjib@ociuslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Miss Nilima Mohanty |
| Designation |
Senior Scientist |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
No.325, P.H road, Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9791021271 |
| Fax |
|
| Email |
nilima@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sanjib panda |
| Designation |
Head Operation |
| Affiliation |
Ocius Life Sciences Private Limited |
| Address |
No.325, P.H road, Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9003580729 |
| Fax |
|
| Email |
sanjib@ociuslife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences Private Limited, No. 325, P.H. Road,
Aminjikarai,
Chennai-600029,
Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Olene Life Sciences Private Limited |
| Address |
No. 325, P.H. Road,
Aminjikarai,
Chennai-600029,
Tamil Nadu, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Kumar Gupta |
Maharaja Agrasen Hospital |
Department of Urology, West Punjabi Bagh, New Delhi-110026
New Delhi
DELHI |
9810046353
akg.urogyn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Premature Ejaculation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OLNP-05 |
One capsule of 500mg Twice daily |
| Comparator Agent |
Placebo |
One capsule of 500mg Twice daily |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Male subjects, aged ≥ 21 years to ≤ 60 years at the time of informed consent
2. Subject having a monogamous, heterosexual relationship and expected/planned to maintain this relationship for the duration of study
3. Subjects having baseline Intravaginal Ejaculatory Latency Time (IELT) of <2 minutes
4. Subjects meeting with diagnostic criteria for premature ejaculation (PEP score ≥11)
5. Subject and his partner agreeing to attempt sexual intercourse 2 times/ week and to use stopwatch during the intercourse
6. Subject willing to give written informed consent and willing to comply with trial protocol |
|
| ExclusionCriteria |
| Details |
1. Previous events or other conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
2. Subjects with genital anatomical deformities including but not limited to penile deformities
3. Subjects for whom sexual activity is inadvisable because of their underlying disease status.
4. Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
5. Subjects with significant and uncontrolled hematological /metabolic/ endocrinologial/ respiratory/ cardiovascular/ neurological/psychiatric/liver/ gastrointestinal/kidney diseases or other significant pathological conditions which as judged by Invesutigator may affect subject participation in the study
6. Any concomitant treatment which is not permissible
7. Continuing history of alcohol and / or drug abuse
8. Recent participation in another clinical trial or receive some other drug during the study besides that in the protocol that known to alter the pharmacokinetics/pharmacodynamic profile of the study drug.
9. Subject having a known allergy to any of the ingredients of investigational prodcut
10. Any other condition that in the opinion of the Investigator does not justify the subject’s participation in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Change from baseline in Intravaginal Ejaculatory Latency Time (IELT) |
Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in Improvement in individual parameters of premature ejaculation profile (PEP) scores |
Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56) |
| Mean change in PEP Index score (Mean of all four measures) |
Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56) |
| Clinical Global impression- Improvement from visit-3 to visit 4 |
Visit 3 (Day 28) and Visit 4 (Day 56) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Based on the findings from different Indian studies, commonly reported premature ejaculation in adult Indian males attending psychosexual clinics is 77.6% and studies conducted in the skin out-’patient department have also found 16.6% of patients suffering from premature ejaculation. So this randomized, double blind, placebo control, parallel group study is designed to access the efficacy and safety of OLNP-05 capsule for the treatment of premature ejaculation. OLNP-05 is a combination of four herbal extracts with syngergistic action in patients with premature ejaculation. The study composed of total four visits with approximate duration of 56 days. A total 60 subjects will be visited study site during screening visit (Day-7 to 00), randomization visit (Day 1), treatment visit (Day 28) and end of study visit (Day 56). After confirming the inclusion and exclusion criteria subject will be randomized to test group (OLNP-05 capsule) or control group (placebo).
The efficacy end point is focused to determine the effect of OLNP-05 and placebo on the basis of Intravaginal Ejaculatory Latency Time (IELT), premature ejaculation profile(PEp) score and Clinical Global impression- Improvement scale (CGI-I). The safety endpoints of the study includes the change in vital parameters, laboratory parameters and incidence of adverse events.
The pretended duration of the study is approximately 6 months. |