CLINICAL EFFICACY OF SPARK IN THE MANAGEMENT OF OLIGOZOOSPERMIA AND ASTHENOZOOSPERMIA

Phase 1

Completed

• Conditions: established cases of Oligozoospermia and Asthenozoospremia; fulfilling the criteria of inclusion

• Registration Number: CTRI/2016/09/007298
• Lead Sponsor: VASU Health Care Pvt Ltd

Brief Summary

Since Vedic period, to have healthy and long living children hasbeen desired, whereas infertility has been considered as a cursed condition andis looked as a medico-social problem. According to *Ayurveda*, *Shukra* is consideredas the essence of all *Dhatu and* *Garbhotpatti* is its prime function.*Dhairya, Preeti, Dehabala* and manyother psychosomatic factors depend upon the status of *Shukra*. Today, increased mental stress, faultyeating & life style have endangered reproductive capacity of men, leading oligozoospermia(*Ksheena Shukra*) andasthenozoospremia and ultimately to infertility. Oligozoospermia andAsthenozoospremia 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 testiculartrauma or vasectomy. Oligozoospermia and Asthenozoospremia may also result fromscarring due to surgery on the male reproductive system or from infection andsexually transmitted diseases. Other causes are disorders oftestis, reduced synthesis of testosterone or defective spermatogenesis. Recent studies haverevealed that the problem of male infertility is on the rise in the country.Rough estimates suggest that nearly 30 million couples in the country sufferfrom infertility, making the incidence rate of infertile couples at 10 percent, and in 40 to 50 per cent cases, the male is the affected partner. Out ofseveral causes of male infertility, in clinical practice Oligozoospermiaand Asthenozoospremia are considered as one of the most prevalent causes. Though theproblem is on the rise, the good part is that 80 per cent of the infertilityproblems can be corrected through simple medication.

Further, on the basis of variousresearch conducted by Carlsan et al, between 1938 to 1988, it is relevant that spermcount, has come down from 130 million/ml of semen to 66 million/ml of semen.Various modern therapeutic measures and associated reproductive technologieslike artificial insemination, test tube baby etc. are very expensive and commonman cannot afford for it. Further results are not very encouraging. Hence,there is a search for alternative treatment modalities in other system ofmedicine, which is safe and cost effective.

This is reason why; today toexplore fertility agents from herbal source is of top priority in the field ofresearch in Andrology. WHO report also states that, good evidence of efficacy existsfor some herbal medicine, but evaluation is inadequate. Considering thesefacts, 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 toevaluate role of *Capsule Spark* onseminal parameters with special focus on Oligozoospermia and Asthenozoospremiaand possible effect of this trial drug on the hormones FSH, LH and Testosteronelevels, which also contribute in spermatogenesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-24
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar

🇮🇳Jamnagar, GUJARAT, India

DR AB THAKAR

Principal investigator

02882676856

anup_thakar@yahoo.com