FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 ShukraToday, 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.

 
Close