| CTRI Number |
CTRI/2010/091/000574 [Registered on: 02/06/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
A clinical trial to study the effects of Paternia in male patients with Infertility |
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Scientific Title of Study
|
An Open, Prospective, Double Blind, Randomised, Multicentre Study to Assess the Safety and Efficacy of Paternia in Male Infertility |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZN01-09 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. P.M. Gopinath |
| Designation |
|
| Affiliation |
|
| Address |
Sooriya Hospital
1/1, Arunachalam Road, Saligramam
Chennai
TAMIL NADU
600093
India |
| Phone |
(044) 42736659 |
| Fax |
|
| Email |
dgopinath@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. P.M. Gopinath |
| Designation |
|
| Affiliation |
|
| Address |
Sooriya Hospital
1/1, Arunachalam Road, Saligramam
Chennai
TAMIL NADU
600093
India |
| Phone |
(044) 42736659 |
| Fax |
|
| Email |
dgopinath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. P.M. Gopinath |
| Designation |
|
| Affiliation |
|
| Address |
Sooriya Hospital
1/1, Arunachalam Road, Saligramam
Chennai
TAMIL NADU
600093
India |
| Phone |
(044) 42736659 |
| Fax |
|
| Email |
dgopinath@yahoo.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Nil |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Bharti Kalra |
Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Haryana |
Consultant Gynaecologist,Bharti Hospital, Wazir Chand Colony, Kunjpura Road-132001
Karnal
HARYANA |
brideknl@gmail.com |
| Dr. Kapil Kochhar |
Men's Health Clinic, Indore, Madhya Pradesh |
Men?s Health Clinic 110/111, Sterling Arcade,15/3, Race Course Road, Opposite IDA building-
Indore
MADHYA PRADESH |
drkapilkochhar@gmail.com |
| Dr. Ajit Saxena |
Menz Health Clinic, Uttar Pradesh |
Consultant Urologist & Andrologist,Menz Health Clinic X-9, Sector 12-
|
ajitsaxena@hotmail.com |
| Dr. P.M. Gopinath |
Sooriya Hospital, Chennai |
Sooriya Hospital,1/1, Arunachalam Road, Saligramam -600093
Chennai
TAMIL NADU |
(044) 42736659
dgopinath@yahoo.com |
| Dr. Sonia Malik |
Southend Fertility & IVF Centre, Holy Angels Hospital, New Delhi |
Southend Fertility & IVF Centre, Holy Angels Hospital,Vasant Vihar-
New Delhi
DELHI |
sm_doc@rediffmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Male Infertility, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Paternia tablets |
One tablet twice daily |
| Intervention |
Paternia tablets |
Two tablets twice daily |
| Comparator Agent |
Placebo |
Two tablets twice daily |
|
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Inclusion Criteria
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| Age From |
|
| Age To |
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| Gender |
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| Details |
1. Age between 21 to 50 years
2. Sperm count ? < 50 million/cu mm
3. Sperm motility < 50 % (according to World Health Organization [WHO] 1999 criteria)
4. Normal Sperm morphology < 50 %
5. No history of taking therapy for infertility
6. No history of obstructive azoospermia
7. Normal female partner
8. Willing to sign Informed consent
9. Subjects likely to be available for all visits during follow-up period |
|
| ExclusionCriteria |
| Details |
1. Any organic cause for male factor infertility
2. Prostato-vesiculo-epididymitis
3. Not planning for IVF etc in the proposed study period
4. Abnormal hormonal profile: gonadotropins, T, E 2, and PRL, FSH>15
5. Presence of antispermatozoa antibodies
6. Severe oligospermia
7. Varicocoele
8. Azoospermia
9. Presence of infectious genital diseases
10. Seminal white blood cells (WBCs) more than 1 x 10 6/mL
11. Major hepatic and Renal disease
12. Myopathy
13. Primary testicular diseaease
14. Subject with history of allergy to any ingredient of the formulation
15. Subject not likely to be available for follow-up.
16. Participation in another clinical trial in the past 3 months |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS test |
Day 0, 90, 180, 270 & 360 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Pregnancy Rate |
Day 0, 30, 60, 90, 180, 270 & 360 |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This study is an randomized, double blind, comparative, multicentric placebo controlled study comparing the safety and efficacy of two dosage schedules of Paternia tablets as one tablet twice daily or two tablets twice daily each for 360 days in 140 male patients with infertility that will be conducted in five centers in India. The primary outcome measures will be the improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI) and fertilization potential by HOS test. |