| CTRI Number |
CTRI/2018/04/013437 [Registered on: 24/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of Speman GNX Tablet for Low sperm count |
|
Scientific Title of Study
|
A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate the Efficacy and Safety of Speman GNX Tablet in Oligospermia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/32/2018 V1 01-Mar-2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTSrinivasan |
| Designation |
Urologist |
| Affiliation |
Pearl Health Care |
| Address |
Pearl Health Care,
No.1491, T.S.Krishna Nagar,
Mogappair
Chennai
TAMIL NADU
600037
India |
| Phone |
8072033356 |
| Fax |
|
| Email |
srinivasan.thimmaraju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTSrinivasan |
| Designation |
Urologist |
| Affiliation |
Pearl Health Care |
| Address |
Pearl Health Care,
No.1491, T.S.Krishna Nagar,
Mogappair
Chennai
TAMIL NADU
600037
India |
| Phone |
8072033356 |
| Fax |
|
| Email |
srinivasan.thimmaraju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Research and Development,
Makali
Bangalore
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company,Makali, Bengaluru 562 162, India |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Makali, Bengaluru 562 162, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTSrinivasan |
Pearl Health Care |
No.1491,Dept of Urology, T.S.Krishna Nagar,
Mogappair
Chennai
TAMIL NADU |
8072033356
srinivasan.thimmaraju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One tablet twice daily |
| Intervention |
Speman GNX tablet |
1 tablet twice daily |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Healthy males 21-45 years of age with infertility for more than 3 months, diagnosed with Oligospermia (Defined by < 15 million sperms/ ml) as per the WHO standards
2.No past history of renal, hepatic or any other chronic illness in the past
3.Normal liver and renal functions tests
4.Patients freely willing and able to provide written informed consent, willing to follow study procedures
|
|
| ExclusionCriteria |
| Details |
-Complete azoospermia in pre-treatment samples
-Any congenital anomaly resulting in oligospermia
-Evidence of male accessory gland infection,
-Any recent medical or surgical illness,
-Hormone/ any other treatment for promoting fertility in the last three months.
-The patients with undescended testis, evidence of thyroid diseases, inguinal hernia, moderate to moderate to severe diabetes with complications and other systemic diseases requiring specific therapies will be excluded from the study.
-Not willing to provide the informed consent form
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improve in the sperm count to normal level.
2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value
|
1.Improve in the sperm count to normal level.
2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of adverse events during the study period.
2.Number of conceptions measured in the course of clinical trial. |
Visit 0- Screening Visit
Visit 1- At entry visit
Visit 2- At the end of day 30
Visit 3- At the end of day 60
Visit 4- (End of the treatment) At the end of day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
05/04/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is A Randomized, Double blind, Placebo controlled
Clinical Study to Evaluate the Efficacy and Safety of Speman GNX Tablet in
Oligospermia for the treatment of male infertility. This formulation
is intended to improve sperm count, sperm quality, sperm morphology,
motility. In this study, 60 cases will be enrolled. 30 patients each in
trial group and placebo group and advised to take the study drug for a period
of 90 days.
The Investigational product will be one of the
formulations either Speman GNX tablet or placebo which is as per the
randomization with dose of one tablet twice daily for 90 days. Patients will be
followed up for Clinical assessment, and lab examination at screening and
at end of study visit. Semen analysis will be done at Entry, Day 30, Day
60 and Day 90.
The present study showed that subjects treated with Speman
GNX tablet showed significant improvement in oligospermia. There was significant
improvement in semen volume, sperm count, pH was maintained at normal range,
increased sperm motility and improved sperm morphology as compared to placebo. The
hormonal parameters like testosterone was normalised in Speman Gnx group. In Speman GNX group there was a trend of improvement from Day 30 onwards. Overall response to Speman GNX in oligospermia was
found to be good. The efficacy of Speman GNX tablets can be attributed
to the synergistic actions of the potent herbs present in the formulation. There
was no improvement seen in the placebo group. Present study indicates that Speman GNX is safe
and effective in the management of oligospermia.
|