| CTRI Number |
CTRI/2017/09/009618 [Registered on: 04/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on JP-16 Capsules in impotency |
|
Scientific Title of Study
|
An open label, interventional, multi-center, prospective clinical study to Evaluation of Efficacy and Safety of JP-16 Capsules in Patients Suffering from Mild to Moderate Sexual Dysfunction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. JP16/SD/01/2016, Version 1. 0, 4th Mar 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendrakumar Bhanudas Mundhe |
| Designation |
Assistant Professor-Departmental of Kayachikitsa |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi Taluka Shirpur Dist Dhule |
| Address |
OPD No 5 Ground Floor
KVTR Ayurvedic College and Hospital Boradi Taluka Shirpur Dist Dhule
Dhule
MAHARASHTRA
424428
India |
| Phone |
09850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chatarubhuj Pharmaceutical Co.
Plot no. 77 Sector 6-A, II-E, SIDCUL, Haridwar. Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Chatarubhuj Pharmaceutical Co |
| Address |
Plot no. 77 Sector 6-A, II-E, SIDCUL,Haridwar. Uttarakhand
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendrakumar Bhanudas Mundhe |
KVTR Ayurvedic College Boradi |
OPD No 5 Ground Floor
KVTR Ayurvedic College and Hospital Boradi Taluka Shirpur Dist Dhule
Dhule
MAHARASHTRA |
09850378206
drnbmundhe@gmail.com |
| Dr Kamalakar Vasant Gajare |
MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra |
Shalaytantra Department
OPD no 3 MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Saneguruji Aarogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
09850123482
drgajarekv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KVTR Ayurvedic College, Boradi, Institutional Ethics Committee |
Approved |
| MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Saneguruji Aarogya Kendra, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
erectile dysfunction , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JP-16 Capsules |
JP-16 Capsules contains Keshar, Akarkara, Vang, Vidhara, Javitri, Abhrak Bhasm, Swarna Bang, Makardhwaj, Pushpadanwa Ras, Kapoor and others
Dosage and Treatment Duration: 2 capsules twice daily orally after food with water for a period of 30 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
2. Subject without any organic cause of Sexual Dysfunction.
3. Subjects should be in an active stable sexual relationship for the duration of study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes
2. Subjects with total erectile failure or any other sexual disorder
3. Subjects with history of disorders that may cause priapism
4. Subjects with history of major psychiatric disorder
5. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
6. Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate efficacy of JP2016 Capsule Erectile function of penis on Erectile function subscale of IIEF Questionnaire
2.To evaluate efficacy of JP2016 Capsule on Hardness of penis on Erection Hardness Score |
Day -3, Day 0, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate efficacy of JP2016 Capsule on Male sexual health on EDITS questionnaire
2.To evaluate efficacy of JP2016 Capsule by assessing Changes in serum testosterone levels
3.To evaluate efficacy of JP2016 Capsule on Global assessment for overall improvement by the investigator and by the patient at the end of the study treatment
4.To evaluate Tolerability of JP2016 Capsule
5.Adverse events
6.Laboratory parameters |
Day -3, Day 0, Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/04/2016 |
| Date of Study Completion (India) |
25/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is an open label, interventional, multi-center, prospective clinical study to
evaluate efficacy and safety of ‘JP2016 Capsule’ in 40 patients suffering from
mild to moderate erectile dysfunction. The study will be conducted at two sites
in India. The dose of the drug would be
2 capsules two times daily orally after meals for 30 days. The primary outcome
measures will be to assess efficacy of ‘JP2016 Capsule’ on erectile function of
penis using Erectile function subscale of IIEF Questionnaire, and to assess
hardness of penis on Erection Hardness Score (EHS) on day 0, day, 15 and day
30. The secondary outcomes will be to assess efficacy of ‘JP2016 Capsule’ on
Male sexual health on EDITS questionnaire (Patient & Partner version), on
Quality of Sexual life on Sexual Quality of Life Questionnaire (SQoL-M), on
Changes in serum testosterone levels (Free and Total), assessment of sexual
encounter profile as per the recordings in daily diary card, assessment of drug
compliance, assessment of Global assessment for overall improvement by the
investigator and by the patient at the end of the study treatment, assessment
of tolerability of study drug by assessing adverse events and assessment of
laboratory parameters on day 0, day 15 and day 30 |