| CTRI Number |
CTRI/2009/091/000551 [Registered on: 28/07/2009] |
| Last Modified On: |
04/02/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of oxidative stress as a cause for idiopathic male infertility and the role of Addyzoa in its treatment |
|
Scientific Title of Study
|
Evaluation of oxidative stress as a cause for idiopathic male infertility and the role of Addyzoa in its treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Department of Urology
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594884 |
| Fax |
01126588663 |
| Email |
rajeev02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Department of Urology
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594884 |
| Fax |
01126588663 |
| Email |
rajeev02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Department of Urology
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594884 |
| Fax |
01126588663 |
| Email |
rajeev02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharma Pvt Ltd,Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Dr Rajeev Kumar |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Research Section, AIIMS |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajeev Kumar |
AIIMS, New Delhi |
Dept. Urology,AIIMS, Ansari Nagar-110029
New Delhi
DELHI |
01126594884
01126588663
rajeev02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Male infertility, Idiopathic oligo/astheno/teratozoospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addyzoa capsules |
2 BD for 3 months |
| Comparator Agent |
Placebo |
2 BD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Infertile male, normal semen volume with either oligospermia (sperm density between 5 and 20 million/mL) or asthenospermia or teratospermia by WHO criteria |
|
| ExclusionCriteria |
| Details |
Identifiable cause for semen abnormality (varicocele, cryptorchidism, orchitis, radiation, chemotherapy, recent febrile illness, hormonal abnormality etc) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in semen parameters |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pregnancy |
Upto 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/03/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Kumar R, Saxena V, Shamsi MB, Venkatesh S, Dada R. Herbo-mineral supplementation in men with idiopathic oligoasthenoteratospermia: a double blind randomized placebo controlled trial. Indian J Urol. 2011;27;357-62 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Addyzoa is a herbomineral product. It is promoted as a spermatogenic antioxidant that scavenges free radicals and reduces oxidative stress. This randomized, double blind, placebo controlled parallel group study aims to evaluate its benefits in men with idiopathic oligo/astheno/teratozoospermia. |