INTRODUCTION

Vajikarana, also known as VrishyaChikitsa, is the area of specialty in Ayurveda since time

immemorial and is one of the most specific and popular branch of Ayurveda. In Vajikarana,

reproductive health is described in detail under different headings like Vajikarana, ShukraDushti,

Artava Dushti, Klaivya, Napumsaka, Yonivyapada, Artavavaha and Shukravaha Srotas

Dushti,andPunsavana Samskara etc. As per Ayurveda classics,Garbhotpadana is a vital function

of Shukra Dhatu. Charaka has described characteristic features of fertile Shukra Dhatu,i.e.,Shukra

should be abundant in quantity, thick and viscous in consistency, Madhura in Rasa, Madhu like

Gandha, Guru (heavy) in Guna and Shukla in Varna.

1

As per World Health Organization (WHO), Oligozoospermia is a condition where sperm

count is below 15 million/mL.2 Oligozoospermia refers to semen with a low concentration ofsperm

and is a common finding in male infertility. The WHO has defined infertility as a disease of the

reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more

of regular unprotected sexual intercourse5

. Male infertility refers to the inability of a male to

achieve a pregnancy in a fertile female. Some of the known responsible factors for male infertility

are poor semen quality, genetical factors, testicular dysfunction and endocrine inter relationship

etc.3

. Among these, Oligozoospermia contributes as one of the major factors of male infertility.

Drastic change in day to day activities including life style, food habits, sexual life, increase in

environmental pollution, industrial and occupational hazards have contributed to the increased

incidence of Oligozoospermia.

Oligozoospermia can be caused as a result of many factors which may be either permanent

or reversible. Some of the causes of Oligozoospermia include an obstruction of the normal flow of

sperm due to testicular trauma and vasectomy, infection and sexually transmitted diseases. Other

causes are reduced synthesis of testosterone or defective release of Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) from pituitary.

Vajikarana is a special branch of Ayurveda dealing with the treatment of sexual

dysfunction and infertility and to improve the sexual performance and quality and quantity of Retas

(semen). Various seminal abnormalities are held responsible for male infertility like reduced

number of sperms, reduced motility and morphological abnormalities etc. which are described in

Ayurveda under eight types of Retodushti. Oligozoospermia, one of the seminal abnormality with

reduced sperm count, can be correlated with KsheenaShukra, one of the Retodushti which happens

due to increased Vata&PittaDosha. Any abnormality in Shukra dhatu ultimately results in failure

of conception. As per modern medical science, the most common abnormalities of sperm are

Oligozoospermia (low sperm number), asthenozoospermia (reduced motility of sperm) and

teratozoospermia (abnormal morphology of sperm).

PREVALENCE

Infertility is defined as the inability of a couple to achieve parenthood even after 1 year of coital

activity without contraception (Mosher and Pratt, 1991). As per WHO estimates, 60-80 million

couples (8-12%) worldwide currently suffer from infertility. In India, according to WHO, the

overall prevalence of primary infertility ranges between 3.9to16.8%.4 It was reported that 40% of

infertility cases were related to men, 40% to women and 20% to both sexes.5 Therefore, a male

factor is present in one half of infertile couples.

NEED OF STUDY

Infertility is a social stigma affecting the psychological harmony, sexual life and social functioning.

The person who is infertile is said to be Nindya and the person without a child is compared to the

tree without branches.6 A lot of research work is being done for the treatment of Oligozoospermia

in both modern as well as Ayurvedic System of Medicines. Each science has its own claims over

the management and success rate for minimizing the prevalence of Oligozoospermia. But still, a

promising cure for Oligozoospermia is not found yet. In modern medical science, management of

infertility includes hormonal supplementation and assisted reproductive techniques but it has its

own limitations and adverse effects too.

Ayurveda may provide a ray of hope through its holistic approach and radical treatment

like Shodhana and Shamana which corrects the basic pathology by eliminating the chief causative

factors without any adverse effect. The life of infertile couple moves around doctors, laboratories for frequent evaluation every month with two weeks of hope and two weeks of despair, resulting

into disharmony in personal, familial, social and financial aspect. Therefore, to find out a safe,

economic, effective treatment for Oligozoospermia, the current study is envisaged as the probable

solution and the same is entitled as:

“Evaluation of the Efficacy of VrishyaShatavariGhrita and Gokshuradi Churna

after Koshtha Shuddhi with HaritakyadiChurna in the Management of Ksheena

Shukra W.S.R. to Oligozoospermia

SELECTION OF DRUG

KsheenaShukra is one of the Retodushti which is due to increased Vata&PittaDosha. Ghrita is

used for the elimination of vitiated Vata&Pittadosha. Ayurveda fundamentals describe that the

drugs with similar properties of any Dhatu nourishes that every Dhatu. Gokshuradi Churna

contains Gokshura, Shatavari, Kapikachchhu, Ikshuraka, Nagabala, Atibala which are having

Vrishya, Shukrala and Balya property and beneficial in Ksheena Shukra.

Vrishya ShatavariGhrita and Gokshuradi Churna followed by Koshtha Shuddhi with

Haritakyadi Churna directly convert into Shukra Dhatu after their digestion and assimilation. So

in the present clinical trial, above Vrishya drugs are planned. It contains Snigdha Guna, Sheeta

Veerya, and Madhura Vipaka as that of Shukra Dhatu. As per Samanya-Vishesha theory of

Ayurveda, it will be beneficial in the treatment of Ksheena Shukra. The contents of these drugs are

easily available and very effective.

REVIEW OF PREVIOUS WORK

As per scholar knowledge and available search materials , no any research work has been carried out on â€œEvaluation of the Efficacy of Vrishya Shatavari Ghrita and Gokshuradi Churna

after Koshtha Shuddhi with HaritakyadiChurna in the Management of Ksheena

Shukra W.S.R. to Oligozoospermia in any Ayurveda institute till date.

AIM

 To evaluate and compare the clinical efficacy of Vrishya Shatavari Ghrita and

‘Gokshuradi Churna after Koshtha Shuddhi with Haritakyadi Churna in the

management of ‘Ksheena Shukra’W.S.R. to Oligozoospermia.

OBJECTIVES

 1. To evaluate the clinical efficacy of Vrishya Shatavari Ghrita after

Koshtha Shuddhi with Haritakyadi Churna in the management of ‘Ksheena Shukra’

W.S.R. to Oligozoospermia.

 2. To evaluate the clinical efficacy of Gokshuradi Churna after Koshtha

Shuddhi with Haritakyadi Churna in the management of ‘Ksheena Shukra’ W.S.R. to

Oligozoospermia.

OBJECTIVES

 1. To evaluate the clinical efficacy of Vrishya Shatavari Ghrita after

Koshtha Shuddhi with Haritakyadi Churna in the management of ‘Ksheena Shukra’

W.S.R. to Oligozoospermia.

 2. To evaluate the clinical efficacy of Gokshuradi Churna after Koshtha

Shuddhi with Haritakyadi Churna in the management of ‘Ksheena Shukra’ W.S.R. to

Oligozoospermia.

HYPOTHESIS

• Null Hypothesis (Ho):

i.Gokshuradi Churna after Koshtha Shuddhi with HaritakyadiChurna is not effective in

the management of Ksheena Shukra W.S.R. to Oligozoospermia. ii.

VrishyaShatavariGhrita after Koshtha Shuddhi with HaritakyadiChurna is not effective

in the management of Ksheena Shukra W.S.R. to Oligozoospermia.

iii. Gokshuradi Churnaand VrishyaShatavariGhrita after Koshtha Shuddhi with

HaritakyadiChurna are equally effective in the management of Ksheena Shukra

W.S.R. to Oligozoospermia.

• Alternative Hypothesis (HA):

i. Gokshuradi Churna after Koshtha Shuddhi with HaritakyadiChurna is effective in

the management of Ksheena Shukra W.S.R. to Oligozoospermia. ii.

VrishyaShatavariGhrita after Koshtha Shuddhi with HaritakyadiChurna is effective in

the management of Ksheena Shukra W.S.R. to Oligozoospermia. iii. Gokshuradi Churna

and VrishyaShatavariGhrita after Koshtha Shuddhi with HaritakyadiChurna are not

equally effective in the management of Ksheena Shukra W.S.R.to Oligozoospermia.

SCREENING CRIETERIA

Inform consent

#Eligibility evaluation

when patients will come in hospital with eligibility conditions then diagnostic assessment will be carried out.

D. Diagnostic criteria:

Newly diagnosed patients of Sperm count <15 million/mL

E. Outcomes and Measurements with Duration:

Time frame baseline to end of 60th day but range of serum testosterone and semenanalysis

will be carried out on 75th day only.

*Pre-trial screening:

• Informed consent

• Eligibility evaluation

• Physical examination • Laboratory investigations *During

selection (baseline):

• General information- Personal identification and demographic profile

• Medical history, general physical and systemic examination

• Assessment of Ayurvedic parameters

• Issue of drugs

• Instruction to come after each 15 days gap for up to 60 days

I.GROUPING:

All the patients fulfilling the criteria of diagnosis and inclusion will be randomly divided

into two groups named as Group A and Group B consisting of 20 patients each.

ï‚¢ Group A:  20 registered patients of Oligozoospermia will be administered

‘VrishyaShatavari Ghrita’in the dose of10 mL once a day orally, before meal in the

morning with luke warm milk for the duration of 60 days,after Koshtha Shuddhi

with‘Haritakyadi Churna’ by/in 7 days.

 Group B: 20 registered patients of Oligozoospermia will be administered ‘Gokshuradi

Churna’in the dose of3 grams twice a day orally, before meal with luke warm milk for the

duration of 60 days,after Koshtha Shuddhi with‘Haritakyadi Churna’ by/in 7 days.

J.Duration of of clinical trial and follow up study:

Total Duration of Trial: 60 days

Follow up: Follow up will be done every 15th

, 30th

, 45th and 60th day to assess the status

And completion of trial for any relapse. And only a special follow up for analysis of serum

testosterone and semen analysis will be carried out on 75th day.

K.Criteria for withdrawal:

 During the course of trial if any serious condition or any serious adverse effects ocurequiring

urgent treatment.

 Patient himself wants to withdraw from the clinical trial.

K.Criteria for withdrawal:

 During the course of trial if any serious condition or any serious adverse effects ocurequiring

urgent treatment.

 Patient himself wants to withdraw from the clinical trial.

L.Criteria of Assessment:

Subjective parameters: Appropriate scoring patternto be adopted of the main signsand

symptoms in this study are as follows:

O The scoring pattern of Mehra and Singh (1995)will be adopted with little

changes for the assessment of the effect of therapies on sexual

parameters.

1. Sexual desire:

0 - Self and partner normal desire

1 - Desire only in demand of partner

2 - Lack of desire 3. No desire at all

2. Erection:

0 - Full swelling whenever desire

1 - Erection with occasional failure

2 - Some swelling, able to penetrate

3- Very slight swelling but unable to penetrate

4- Erection with artificial method

5- No erection or swelling without any methods

3. Ejaculation:

0 - During sexual intercourse >60 sec / at least >10 pelvic thrusts

1 - During sexual intercourse < 60 sec / at least 5-10 pelvic thrusts

2 - During sexual intercourse < 30 sec / at least 1-5 pelvic thrusts

3 - Before penetration

4 - During foreplay

5- On mere thoughts/ slight or no ejaculation at all

4. Feeling after sex:

0- Satisfaction after every act

1- Satisfaction in 75% act

2 Satisfaction in 50% act

3 Satisfaction in 25% act

4 No satisfaction after every act

5. Performance anxiety:

1 - No anxiety at all

2- Slight anxiety, does not hamper sexual act

2 - Anxiety that hamper in 25% encounters

3 - Anxiety that hamper in 50% encounters

4 - Anxiety that hamper in 75% encounters

5 - Anxiety that hamper in almost all the encounters

6. Post act Exhaustion:

1 - No exhaustion at all

2- Slight exhaustion occasionally

2 - In 25% of the encounters

3 - In 50% of the encounters

4 - In 75% of the encounters

5 - After every sexual act

7. Feeling of partner after sex:

0 - Satisfaction after every act

1 - Satisfaction in 75% act

2 - Satisfaction in 50% act

3 - Satisfaction in 25% act

4 - No satisfaction after every act

8. Daurbalya (weakness):

1 - No weakness

2 - Slight weakness

3- Weakness but routine work not affected

3 - Weakness and routine work affected

4 - Can’t do any work

9. Mukhashosha (dryness of mouth):

0– No dryness of mouth

1- Drynessrelieved by anything putting in mouth

2 - Dryness not relieved by anything putting in mouth

OBJECTIVE PARAMETERS:     Lab.Investigation:

On the very first and last day of the trial, following laboratory investigations will be performed for proper

diagnosis and to rule out any major pathological abnormalities:

Hematological parameters     : CBC (Haemoglobin%, TLC, DLC), ESR                                                                  # Biochemical  parameter        : Random Blood Sugar (RBS)

#Renal Function Test               : Blood Urea, Sr. Creatinine

Liver Function Test                : SGOT, SGPT

Lipid Frofile                            : Sr. Cholesterol, Sr. Triglyceride

Semen Analysis                     : Sperm Count, Volume, Motility, Morphology,

Sr. Testosterone

Routine examination and assessment:

Entire details of history and physical examination of each patient will be recorded as per the

proforma. Clinical and physiological assessment will be done before treatment, during

treatment and at the end of treatment and results will be analyzed with appropriate statistical

tests.

Statistical Analysis:

The information will be gathered on the basis of observations made about various parameters

will be subjected to statistical analysis in terms of Mean, StandardDeviation and Standard

error (SE). SigmaStat 4.0 software or its available higher version will be used and for

Nonparametric Data Wilcoxon matched-pairs signed ranks test will be used, while for

parametric data paired ‘t’ Test will be used and results calculated. Paired t test will be carried

out at p<0.05, p<0.01, p<0.001.

For intergroup comparisons, Mann-WhitneyTestwill be used for the non-parametric variables

while for parametric variables, unpaired‘t’ Test will be used as for statistical analysis.

Following significant levels will be kept for calculation of the results:

Non significant: P >0.05

Significant: P <0.05

Highly significant: P < 0.01, P < 0.001, P< 0.0001 will be used

REFERENCES:

1. Ashtanga sangraha Shareera sthana 1/17..

2. WHO Criteria for normal semenogram 2010. Impact of the new

WHO Guidelines on diagnosis and practice on male infertility, the

open reproductive science journal, Vol-3, 2010 page 7-15.

3. Cooper TG, Noonan E, von Eckardstein S, et. Al. (2010). World

Health Organization reference value for human semen characteristics.

Hum. E. Reprod. Date of access: 2/2/2015.

4. WHO, Infecundity, infertility and childlessness in developing

countries. DHS Comparative Reports No. 9, Calverton, Maryland,

USA: ORC Macro and the World Health Organization; 2004.

5. Sadock BJ, Sadock VA. Kaplans and Sadocks symptoms of psychiatry behavirol sciences clinical psychiatry,

9th

ed. Lippincott Williams and Wilkins: Philadelphia;2003. P. 872-4.

6. Agnivesha, Charaka Samhita, revised by Charaka and Dridabala with Elaborated vidyotini Hindi

commentary by Pt. Kashinath shastri Dr.Gorakhanath chaturvedi edited reprinted 2011, Chaukhambha

Bharati Academy, Varanasi, Chikitsa Sthana 2/1/16, page no. 68.

7. Agnivesha, Charaka Samhita, revised by Charaka and Dridabala with Elaborated vidyotini Hindi

commentary by Pt. Kashinath Shastri Dr.Gorakhanath Chaturvedi edited reprinted 2011, Chaukhambha

Bharati Academy, Varanasi, Chikitsa Sthana 2/3/18, page no. 80.

8. Chakradatta of Chakrapanidatta ( Vrasyadikar 67/9) by Dr. Indradeva Tripathi, edited by Prof

Ramanath Dwivedy,Chaukhambha Sanskrit bhawana, Varanasi, Edition reprint 2019.

9. Agnivesha, Charaka Samhita, revised by Charaka and Dridabala with Elaborated vidyotini Hindi

commentary by Pt. Kashinath Shastri Dr.Gorakhanath Chaturvedi edited reprinted 2011, Chaukhambha

Bharati Academy, Varanasi, Chikitsa Sthana 1/1/25-26, page no. 9.