| CTRI Number |
CTRI/2012/09/002950 [Registered on: 03/09/2012] Trial Registered Prospectively |
| Last Modified On: |
07/11/2014 |
| 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 to evaluate efficacy and safety of “TLPL/AY/04/2009†in comparison with placebo in patients suffering from Male Infertility. |
|
Scientific Title of Study
|
“A Randomized, Double Blind, Placebo Controlled, Multi-center, Parallel Group, Clinical Study to Evaluate Efficacy and Safety of “TLPL/AY/04/2009†in Patients Suffering from Male Infertility.†|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TLPL/AY/04/2009/CT-1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar G Bumb |
| Designation |
Chief Gynecologist and Obstetrician |
| Affiliation |
Dr. Bumb Nursing Home |
| Address |
Dr. Bumb Nursing Home Satyam Arcade 1st Floor Ramwadi Nagar Road Pune
Pune
MAHARASHTRA
411014
India |
| Phone |
020-66239629 |
| Fax |
|
| Email |
drsagarbumb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Nipanikar |
| Designation |
Senior Manager Medical Services |
| Affiliation |
R & D Center Tulip Lab Private Limited |
| Address |
R & D Center Tulip Lab Private Limited F 20 & 21 MIDC Ranjangaon Taluka Shirur Dist Pune
Pune
MAHARASHTRA
412220
India |
| Phone |
02138-662976 |
| Fax |
|
| Email |
sanjay.n@tlplindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Nipanikar |
| Designation |
Senior Manager Medical Services |
| Affiliation |
R & D Center Tulip Lab Private Limited |
| Address |
R & D Center Tulip Lab Private Limited F 20 & 21 MIDC Ranjangaon Taluka Shirur Dist Pune
Pune
MAHARASHTRA
412220
India |
| Phone |
02138-662976 |
| Fax |
|
| Email |
sanjay.n@tlplindia.com |
|
|
Source of Monetary or Material Support
|
| Tulip Lab Private Limited F 20 & 21 MIDC Ranjangaon
Taluka Shirur Dist Pune Pin 412220 |
|
|
Primary Sponsor
|
| Name |
Tulip Lab Private Limited |
| Address |
F 20 & 21 MIDC Ranjangaon Taluka Shirur Dist Pune Pin 412220 |
| 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 Sagar G Bumb |
Dr Bumb Nursing Home |
Satyam Arcade 1st Floor Ramwadi Nagar Road Pune 411014
Pune
MAHARASHTRA |
020-66239629
drsagarbumb@gmail.com |
| Dr Suresh A Vyavahare |
Shatayu Ayurveda & Research Center |
Shubharai Tower 2nd Floor
Datta Chowk South Kasaba
Laxmi Market Road
Solapur Pin 413007
Solapur
MAHARASHTRA |
09373840058
shatayu.ayur@gmail.com |
| Dr Sayram R Shrigire |
Shri Vedant Ayurveda Hospital |
Om Nagar Degloor Road
Udgir Dist Latur Pin 413517
Latur
MAHARASHTRA |
9503870611
sayshrigire@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Dhanashree Hospital New Sangvi Pune 411027 |
Approved |
| Independent Ethics Committee Dhanashree Hospital New Sangvi Pune 411027 |
Approved |
| Independent Ethics Committee Dhanashree Hospital New Sangvi Pune 411027 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Male Infertility , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule TLPL/AY/04/2009 |
Each ‘TLPL/AY/04/2009’ Capsule Contains
1. Shwet musali extract (Chlorophytum arundinaceum) 2. Shatavari extract (Asparagus racemosus) 3.Ashwagandha extract (Withania somnifera) 4.Gokshura extract (Tribulus terrestris) 5.Vidarikanda extract (Pueraria tuberosa)
Dosage: 2 capsules twice daily orally after meals with a cup of milk for 120 days
|
| Comparator Agent |
Placebo Capsule |
Each Placebo Capsule Contains:
1. Dibasic calcium phosphate
2. Methyl paraben
3. Propyl paraben
4. Colloidal anhydrous silica
5. Magnesium stearate
6. Size “00†Capsule
Dosage: 2 capsules twice daily orally after meals with a cup of milk for 120 days
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Married male subjects between 21 to 45 years of age.
2. Subjects with the history of minimum 1 year of regular unprotected sexual activity without achieving pregnancy.
3. Subject having Sperm concentration (sperm count; sperm/ml) < 15 millions/ml.
4. Subject having semen volume (total volume of ejaculate) not to be < 1.5 ml per ejaculate,
5. Subject with or without Sperm total motility less than 40% or sperm forward progressive motility less than 32%.
6. Subject having Normal sperm morphology.
7. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with abnormal laboratory investigation(s) (above or below normal range) with corresponding clinical symptoms will not be recruited in the trial.
2. Subjects demonstrating hemospremia, leucospermia, absence of fructose or pH < 7.2 or > 8.0 hyperspermia i.e. > 7 ml ejaculatory volume.
3. Subjects having Klinefelter’s Syndrome, Kartagener Syndrome.
4. Congenital anomalies – spine bifida, congenital bilateral/unilateral absence of vas deference.
5. Subject whose ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
6. Subject whose X- ray chest showing any active lesion of Tuberculosis.
7. Subject whose USG and/or colour Doppler of testes showing hydrocele, varicocele, orchitis, and epididymitis or any other abnormal findings, will not be recruited in the trial.
8. Subjects showing high serum prolactin levels will not be recruited in the trial.
9. Subjects having active metabolic or gastrointestinal diseases or any kind of physical anamoli that may interfere with spermatogenetic process or pathway.
10. Subject having drug dependency or failure to keep abstinence for antioxidant agents, vitamins, anti-inflammatory drugs, hormones, herbal /homeopathic medications.
11. Subject with abuse like smoking, alcohol etc.
12. Subjects having known hepatic or renal disease.
13. Subjects having an active malignancy.
14. Subjects having untreated/uncontrolled hypertension.
15. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
16. Subjects having Diabetes Mellitus.
17. Subjects having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
18. Known hypersensitivity to ingredients used in study drug.
19. Children and women will not be recruited in this study.
20. Occurrence of febrile illness, Temperature > 102 oF within 3 months prior screening.
21. Body Mass Index (BMI) > 35 kg/m2.
22. Subjects who have occupational / environmental exposures to risk factors for male reproductive System, e.g. chronic heat exposure, ionizing radiation, heavy metals like lead, cadmium, certain pesticides, frequent sauna bath etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in total sperm count |
Screening visit (Day -7), Day 0, Day 90 and Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in semen volume, Sperm motility with progressive sperm motility, total number of spermatozoa per ejaculate, Sperm Morphology, viability of spermatozoa,serum levels of total and free testosterone, serum level of prolactin, LH and FSH,
2.Changes in the number of spontaneous achieved pregnancies.
3.Global assessment for overall improvement by the patient and by the Investigator
4.Tolerability of study drugs
5. Changes in Laboratory parameters |
Screening visit (Day -7), Day 0, Day 90 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/09/2012 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
will be a randomized, double blind, placebo
controlled, multi-center, parallel group, clinical study to evaluate efficacy
and safety of “TLPL/AY/04/2009†in patients suffering from Male Infertility. The
trial will be conducted at three different sites in India. A total of 50
subjects suffering from male infertility will be recruited in the trial to get
40 evaluable cases (20 subjects in drug group and 20 subjects in placebo group)
at the end of the trial. As
per computer generated randomization list, subjects will be advised to consume given
medication (either Capsule TLPL/AY/04/2009 or Capsule Placebo) in a dose of 2 capsules
twice daily orally after meals with a cup of milk for 4 months. The
primary objective of the trial will be post treatment changes in total sperm
count. The secondary objectives will be post treatment changes in semen volume,
sperm motility with progressive sperm motility, total number of spermatozoa per
ejaculate, sperm morphology, viability of spermatozoa, serum levels of total
and free testosterone, serum level of LH (luteinizing hormone) and FSH
(follicle stimulating hormone). Secondary objectives of the trial also include
number of spontaneous achieved pregnancies at the end of the trial, post
treatment global assessment for overall improvement by the patient, global
assessment for overall improvement by the investigator, tolerability of study drugs by
assessing ADRs on study completion and post treatment changes in laboratory
parameters. |