| CTRI Number |
CTRI/2025/03/082740 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study evaluates the effectiveness and safety of a product in helping men with premature ejaculation last longer during intercourse. |
|
Scientific Title of Study
|
A Open label Clinical end point study to evaluate the Efficacy and Safety of NATURAL DELAY SPRAY in Male Patients With Premature Ejaculation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NAT/03/25, Version no 0.1, Dated 17.2.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Kanna |
| Designation |
Consultant |
| Affiliation |
Grace Trinity Hospital |
| Address |
Room no. 2, Grace Trinity Hospital, Chepet To Sanjeevanirnagar Road Indira Nagar, Polur, Tamil Nadu
Vellore
TAMIL NADU
606902
India |
| Phone |
9677786774 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kanna |
| Designation |
Consultant |
| Affiliation |
Grace Trinity Hospital |
| Address |
Room no. 2, Grace Trinity Hospital, Chepet To Sanjeevanirnagar Road Indira Nagar, Polur, Tamil Nadu
TAMIL NADU
606902
India |
| Phone |
9677786774 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 private limited |
| Address |
5,Jayalakshmi street, Radha Nagar, Chrompet, Chennai
No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai
Chennai
TAMIL NADU
6000044
India |
| Phone |
900310916 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Pontika India, Vill Johron, PO Puruwala, Nahan Road, Paonta Sahib, Dist–Sirmour, Himachal Pradesh–173001 India |
|
|
Primary Sponsor
|
| Name |
Pontika Aerotech Limited |
| Address |
Vill Johron, PO Puruwala, Nahan Road, Paonta Sahib, Dist–Sirmour, Himachal Pradesh–173001 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kanna |
Grace Trinity Hospital |
Room no. 2, General consultation ward, Chepet To Sanjeevanirnagar Road Indira Nagar, Polur, Tamil Nadu
Vellore
TAMIL NADU |
09677786774
srkguruvarshan@gmail.com |
| Dr Ramesh Kannan |
PM Medical Centre |
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet, Ranipet,
Vellore
TAMIL NADU |
9677786447
srkguruvarshan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PM ETHICS COMMITTEE |
Approved |
| PM ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N531||Ejaculatory dysfunction. Ayurveda Condition: SUKRAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Naturease Spray , Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(NA), Frequency: sos, Bhaishajya Kal: Sabhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Informed consent for subjects and partners
2.Men 20-60 years of age
3.Stable monogamous relation at least for 6 months
4.Premature Ejaculation Diagnosis Tool (PEDT) score of less than 9.
5.At least 6 months of premature ejaculation History
6.IELT (Intravaginal ejaculation latency time) of 2 min and more than 75% of evaluable events during 4 week screening period
|
|
| ExclusionCriteria |
| Details |
1.History of medical or psychiatric illness
2.Erectile dysfunction (21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
3.Partner sexual dysfunction
4.Known hypersensitivity to the ingredients of the test product.
5.Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact the study outcome.
6.History of drug or alcohol abuse during the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intravaginal ejaculation latency time (IELT)
2. Sexual satisfaction will be assessed using a Likert scale.
3. PEDT and AIPE score before and after the treatment of 4 weeks.
|
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical safety assessments, including weight, blood pressure, pulse and adverse events |
Baseline and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 25 subjects diagnosed with Premature Ejaculation and satisfying selection criteria, will be enrolled in the study in a single group. Test Group– NATUREASE SPRAY: 25 subjects : For 4 weeks. Massage 2-6 sprays into the head and shaft of the penis depending on your sensitivity. Apply minimum of ten minutes before intercourse over a period of 4 weeks as per requirement. Subjects will be asked to visit clinical facility/institution for their follow up at week, 2 and 4 weeks for assessment of outcome parameters. |