| CTRI Number |
CTRI/2016/09/007298 [Registered on: 20/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
12/09/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL EFFICACY OF SPARK IN THE MANAGEMENT OF OLIGOZOOSPERMIA AND ASTHENOZOOSPERMIA |
|
Scientific Title of Study
|
EVALUATION OF CLINICAL EFFICACY OF CAPSULE SPARK IN THE MANAGEMENT OF OLIGOZOOSPERMIA AND ASTHENOZOOSPERMIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANUP THAKAR |
| Designation |
HEAD PANCHAKARMA |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
PANCHAKARMA Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
PANCHAKARMA Department Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar Jamnagar GUJARAT 361008 India |
| Phone |
9427776660 |
| Fax |
028882676856 |
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ANUP THAKAR |
| Designation |
HEAD PANCHAKARMA |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
PANCHAKARMA Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
PANCHAKARMA Department Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar Jamnagar GUJARAT 361008 India |
| Phone |
9427776660 |
| Fax |
028882676856 |
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DR ANUP THAKAR |
| Designation |
HEAD PANCHAKARMA |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
PANCHAKARMA Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
PANCHAKARMA Department Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar Jamnagar GUJARAT 361008 India |
| Phone |
9427776660 |
| Fax |
028882676856 |
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching Research in Ayurveda
Gujarat Ayurved University
Jamnagar 361008
|
|
|
Primary Sponsor
|
| Name |
VASU Health Care Pvt Ltd |
| Address |
A Division of VASU Health Care Pvt Ltd 896A GIDC Makarpura Vadodara 390010 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DR AB THAKAR |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Room No 22, OPD Block, IPGT & RA Hospital Jamnagar GUJARAT |
02882676856 02882676856 anup_thakar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ehics committee, IPGT and Ra Gujarat ayurved Unviersity jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
established cases of Oligozoospermia and Asthenozoospremia; fulfilling the criteria of inclusion , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Spark capsule |
Patients will receive 2 capsules of SPARK Capsule twice a day for
60 days followed by a cup of warm milk as an adjuvant. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Age 20 45 years of male
Sperm count below 15 million ml according to WHO 2010
Patient with clinical presentation of Ksheenashukra Oligozoospermia and Asthenozoospremia Daurbalya Klaibya Shukra Avisarga Pandu etc
|
|
| ExclusionCriteria |
| Details |
Age below 21 and above 50 years.
Sperm count more than 15 million per ml
Patient of azoospermia and aspermia
Patients of various diseases like varicocele accessory sex gland infection, sexually transmitted diseases severe systemic diseases etc.Genetic disorders like Klinfelters syndrome
Taking treatment for major psychiatric problem
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on subjective parameters like, Sexual desire, Erection, Rigidity, Performance anxiety, Ejaculation, Orgasm and post act exhaustion will be assessed |
Improvement in the semenogram will be observed especially in total sperm count. Change in S. FSH, S. LH, S. Testosterone will also be evaluated before and after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in the condition, Quality of Life of the individual will be assessed. Based on the observations, a large scale study involving larger populations may be attempted. |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
24/04/2014 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Since Vedic period, to have healthy and long living children has
been desired, whereas infertility has been considered as a cursed condition and
is looked as a medico-social problem. According to Ayurveda, Shukra is considered
as the essence of all Dhatu and Garbhotpatti is its prime function.
Dhairya, Preeti, Dehabala and many
other psychosomatic factors depend upon the status of Shukra. Today, increased mental stress, faulty
eating & life style have endangered reproductive capacity of men, leading oligozoospermia
(Ksheena Shukra) and
asthenozoospremia and ultimately to infertility. Oligozoospermia and
Asthenozoospremia can be the result of many factors, which may be permanent or reversible.
It may result due to an obstruction of the normal flow of sperm such as in testicular
trauma or vasectomy. Oligozoospermia and Asthenozoospremia may also result from
scarring due to surgery on the male reproductive system or from infection and
sexually transmitted diseases. Other causes are disorders of
testis, reduced synthesis of testosterone or defective spermatogenesis. Recent studies have
revealed that the problem of male infertility is on the rise in the country.
Rough estimates suggest that nearly 30 million couples in the country suffer
from infertility, making the incidence rate of infertile couples at 10 per
cent, and in 40 to 50 per cent cases, the male is the affected partner. Out of
several causes of male infertility, in clinical practice Oligozoospermia
and Asthenozoospremia are considered as one of the most prevalent causes. Though the
problem is on the rise, the good part is that 80 per cent of the infertility
problems can be corrected through simple medication.
Further, on the basis of various
research conducted by Carlsan et al, between 1938 to 1988, it is relevant that sperm
count, has come down from 130 million/ml of semen to 66 million/ml of semen.
Various modern therapeutic measures and associated reproductive technologies
like artificial insemination, test tube baby etc. are very expensive and common
man cannot afford for it. Further results are not very encouraging. Hence,
there is a search for alternative treatment modalities in other system of
medicine, which is safe and cost effective.
This is reason why; today to
explore fertility agents from herbal source is of top priority in the field of
research in Andrology. WHO report also states that, good evidence of efficacy exists
for some herbal medicine, but evaluation is inadequate. Considering these
facts, Capsule Spark containing some of the most potent Vajikarana drugs mentioned in classics like Ashvagandha, Kapikachu, Gokshur, Shatavari, Vidarikand, Jatiphala, Bala
in the form of extract with powders of drugs like Narsinha, Shveta Musali, Shuddha Shilajatu, Maricha, Shunthi and Pippali was formulated.
Hence, present study is planned to
evaluate role of Capsule Spark on
seminal parameters with special focus on Oligozoospermia and Asthenozoospremia
and possible effect of this trial drug on the hormones FSH, LH and Testosterone
levels, which also contribute in spermatogenesis. |