| CTRI Number |
CTRI/2019/09/021217 [Registered on: 12/09/2019] Trial Registered Prospectively |
| Last Modified On: |
14/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on IMPERIM® Capsule in erectile dysfunction. |
|
Scientific Title of Study
|
An open label, interventional, multi-center, prospective clinical study to evaluate efficacy and safety of ‘IMPERIM® Capsules’ in patients suffering from mild to moderate erectile dysfunction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BF/ED/2019, Version 1.0, 08th Aug 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagaraj S |
| Designation |
Professor |
| Affiliation |
S.D.M. College of Ayurveda, Kuthpady Udupi |
| Address |
P.G.Department of Rognidana, Ground Floor, OPD No. 7, S.D.M. College of Ayurveda, Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448408722 |
| Fax |
|
| Email |
consultantdr@rediffmail.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
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
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
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Bioveda Lab, Shop no-431 to 438, 4th Floor, Near Radhika Chowkdi,
Opp. Bhaiya nagar BRTS, Punagam, Varacha, Surat- 395010. Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Bioveda Lab |
| Address |
Shop no-431 to 438, 4th Floor, Near Radhika Chowkdi,
Opp. Bhaiya nagar BRTS, Punagam, Varacha, Surat- 395010. Gujarat
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pawankumar Godatwar |
National Institute of Ayurveda |
Department of Roganidana & Vikriti Vijnana,OPD No 7, Ground floor, National Institute of Ayurveda, Madhav Vilas palace, Jorawar Singh gate, Amer Road,Jaipur 302002
Jaipur
RAJASTHAN |
9314502834
gpawankuar@rediffmail.com |
| Dr Rajeshwar Reddy |
R A Podar Medical College (Ayu), M.A.Podar Hospital |
Department of Shalya Tantra, OPD No.4, 1st Floor R A Podar Medical College (Ayu), M.A.Podar Hospital, Worli, Mumbai 400018
Mumbai
MAHARASHTRA |
9820864287
reddyrajeshwr@rediffmail.com |
| Dr Nagaraj S |
S.D.M. College of Ayurveda |
P.G.Department of Rognidana, Ground Floor, OPD No. 7, S.D.M. College of Ayurveda, Kuthpady Udupi 574118
Udupi
KARNATAKA |
9448408722
cosultantdr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Clearance committee –Human, Sri Dharmasthala Manjunatheshwara College of Ayurveda |
Approved |
| Institutional Ethics Committee, R A Podar Medical College (Ayu), M.A.Podar Hospital, Worli, Mumbai |
Submittted/Under Review |
| Institutional Ethics committee,National Institute of Ayurveda, Jaipur |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N529||Male erectile dysfunction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IMPERIM® capsule |
contains Kapikacchu (Mucuna pruriens), Ashvagandha (Withania somnifera), Gokshura (Tribulus terrestris), ShvetMusali (Asparagus adscendens), Inositol
Dosage and Treatment Duration: 2 Capsules twice daily orally after meal with lukewarm water for 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 13 to 24 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
2.Subject without any organic cause of Erectile Dysfunction.
3.Subjects should be in an active stable sexual relationship for the duration of study
4.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form
5.Subjects willing to make all required study visits
6.Subjects willing to follow study instructions given by the investigator |
|
| ExclusionCriteria |
| Details |
1.Subjects with major illnesses and sexual dysfunction due to anatomical surgical or pharmacological causes
2.History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity
3.Presence of any drug or therapy that may have relation with ED and sexual dysfunction
4.Subjects with total erectile failure or any other sexual disorder, hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma
5. Subjects with preexisting systemic disease necessitating long-term medications
6.Continuing history of alcohol and or drug abuse
7.Subjects with significant abnormal laboratory parameters
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of erectile function of penis on Erectile function subscale of IIEF Questionnaire
2.Hardness of penis on Erection Hardness Score (EHS)
|
Day -3, Day 0, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of Sexual desire or Libido and other parameters on IIEF
2.Assessment of Male sexual health on EDITS questionnaire
3.Assessment of Quality of Sexual life on Sexual Quality of Life Questionnaire
4.Assessment of Changes in serum testosterone
5.Assessment of Drug compliance
6.Global assessment for overall change by investigator and patient
7. Tolerability of study drug by assessing adverse events and laboratory parameters.
|
Day -3, Day 0, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/09/2019 |
| 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="0"
Months="8"
Days="0" |
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)?
|
|
Brief Summary
|
It
is an open label, interventional, multi-center, prospective clinical study to
evaluate efficacy and safety of ‘IMPERIM® Capsules’ in patients suffering from
mild to moderate erectile dysfunction. The study will conducted at three sites
in India. Subjects will be advised to consume 2 IMPERIM® capsules twice daily
orally after meals with water for 30 days. The primary objectives of the study
will be to assess erectile function of
penis on Erectile function subscale of IIEF Questionnaire and hardness of penis
on Erection Hardness Score (EHS). The secondary objectives of the study will be
to assess sexual
desire or libido and other parameters on IIEF questionnaire, male sexual health on EDITS questionnaire
(Patient & Partner version), quality of Sexual life on Sexual Quality of
Life Questionnaire (SQoL-M), changes in serum testosterone levels (Free and
Total), drug compliance, global assessment for overall change by investigator
and patient and tolerability of study drug by assessing adverse events and laboratory
parameters |