[A] VI. Brief resume of the intended work
6.1Need for the study
Kama or sexuality is the root of procreation. Every married couple’s dream of getting their own progeny is initiated, mediated and formulated through this Kama. This is possible when the anatomical structures and physiological functions of sex organs of both partners are intact. Otherwise the whole intention becomes in vain. In nutshell, Kama effects in sexual gratification and better progeny to lead happy life, which is perturbed in the absence of the same. Kama is the third pursuit of the man (purushartha) also.
The inability to procreate i.e. infertility is such a condition, which severely affects the couple’s psychological harmony, sexual life, and social stigma and ultimately leads to separation from life partner and many a time to suicide. Hence our ancient Acharyas have stressed much upon Vajikarana tantra, which deals with the management of defective semen and spermatogenesis along with sexual potencification. Vajikarana encompasses fertility, sexuality as well as positive health.
Infertility, defined as the inability to conceive after atleast one year of unprotected intercourse, affects about 15 to 20 % of couples and in 40 % of these cases, male factor is identified as the main cause. Oligospermia is the seminal disorder in which sperm count is below 20 million / ml. Sperm count in healthy males ranges widely between 65 million to 170 million sperms / ml. In modern era, due to stress and strain, and also due to changed life style, the sperm count in healthy males is reducing day by day. This is posing a great threat to new generation.
Even at the present modern era, where the modern science has advanced so much, many a time, physicians are accepting their failure in correcting Oligospermia. Therefore we, the Ayurvedic physicians should continue our efforts to find an effective remedy or therapy, which can relieve the sufferings of patients to maximum possible extent. This is one of the reasons, which prompted our mind to select Ksheena shukra (Oligospermia) for this research work
According to Ayurveda, Shukra should possess such a potency so as to conceive a lady. The impact of defective shukra is infertility. Ksheena shukra is doshabala pravrutha, kruchrasadhya roga of shukravaha srotas. It is understood that vata and pitta dosha are responsible for this condition. It is to be managed with shukra vardhaka or shukrala drugs enriched with madhura rasa, sheeta veerya, guru snigdha guna and highly potentiated with balya, vrishya and rasayana properties.
After going through the available literature, it is found that “Ashwagandhadi Choorna” and “Shatavaryadhi Choorna” posses the above said properties and seems to be effective in correcting the dushti of shukra quantitatively and qualitatively. Hence these compound formulaes are selected for the present study to evaluate their effect on Ksheena Shukra (Oligospermia).
6.2. Review of Literature:
1)Definition of Vajikarana1,2
2)Incidence of Oligospermia and normal range of sperm count 3,4,5
3)Explanation of Ksheena Shukra 6
4)Ashwagandhadi Choorna 7
5)Shatavaryadi Choorna 8
6)Haritkyadi Choorna 9
Previous Works done :
- Pandey S.D. - Clinical evaluation of indigenous Vrishya compounds in cases of Oligospermia, State Ayurvedic College, Lucknow, 1990.
- Rai A.K. - Effect of Avipattikara ghrta in cases of Shukra-alpata (Oligospermia), State Ayurvedic College, Lucknow, 1992.
- Thaker Anup. B - Role of vrishya yoga in the management of Ksheena Shukra (Oligozoospermia), Gujarat Ayurveda University, Jamnagar, 1994.
- Behra. B. S. - A Clinical Study on Oligospermia (Shukra Kshaya) with its management by vidari kanda, Gopabandu Ayurveda Mahavidyalaya, Utkal University, Bhubaneswar, Puri, 1996.
- Ayyagiri R.S. - A comparative study on the role of Baladi Vrishya Vasti and Shatavaryadi yoga in the management of Ksheena Shukra w .s .r. to Oligozoospermia, Gujarat Ayurved University, Jamnagar 1998.
- Gajjar. D. R - Etiopathology of Ksheena Shukra (Oligospermia) and its management with selected compound and Shuddha Shilajatu. I.P.G.T and R.A., Ahmedabad, 1998.
- Pradhan A Kumar – A study on klaibya W.S.R. to Beejopaghata (Oligospermia) and its management with Shatavari – Gopabandu Ayurveda Mahavidyalaya, Utkal University, Bhubaneswar, Puri, 1999.
- Jayapala Singh P.G. - A clinical study on the role of Apatyakara Vati in the management of Vandhyatawa w .s. r. to Oligozoospermia. Govt. Akhandanand Ayurvedic College, Gujarat Ayurved University, Jamnagar, 2000.
- Tripathi S.K. - A clinical study of the effect of Shatavaryadi Choorna in cases of Oligospermia, State Ayurvedic College, Lucknow, 2002.
- Suresh Vyavahare – A clinical study on Ksheena Shukra (Oligo spermia) w .s .r. to Yapana basti and Shatavaryadi yoga, HASS’s Ayurveda Mahavidyalaya, Hubli, Rajiv Gandhi University of Health Sciences, 2003
- Joshi Kalpesh - Comparative study with Mashadhi vati and Amlaki bhavita Shilajatu in the management of Ksheena shukra (Oligospermia). I.P.G.T and R.A., Ahmedabad, 2005.
6.3 Objectives of the study
- To study Ksheena Shukra and Oligospermia according to Ayurveda and Modern science in detail.
- To assess the role of Ashwagandhadi Choorna in Ksheena Shukra (Oligospermia).
- To assess the role of Shatavaryadi Choorna in Ksheena Shukra (Oligospermia).
- To evolve a comprehensive remedy for Ksheena Shukra (Oligospermia).
[B] VII.Materials and Methods
The present study titled “Clinical Management of Ksheena Shukra (Oligospermia) W.S.R. to Ashwagandhadi and Shatavaryadi Choorna – A Comparative Study ”is a clinical trial which will be done with following materials;
- A Compound Preparation called as Ashwagandhadi Choorna containing ingredients such as Ashwagandha, Krishana Tila, Shweta Chandana, Amlaki, Pippali, Mushali, Yashtimadhu, Jatiphala, Rakta Chandana, Jatamamsi, Shatavari, Guduchi, Vidari kanda, Kapikachu, Ela, Lavanga is administered internally.
- A Compound Preparation called as Shatavaryadi Choorna containing ingredients such as Shatavari, Nagabala, Vidari kanda, Gokshura, Amlaki is administered internally.
7.1Source of Data
In the present study, the research scholar proposes to take the patients attending the Outpatient Department of Post Graduate Department of Kayachikitsa, Ayurveda Mahavidyalaya Hospital, Hubli.
7.2Methods of collection of Data
- A clinical survey of patients attending OPD and IPD of Post Graduate Department of Kayachikitsa, Ayurveda Mahavidyalaya Hospital, Hubli, will be made and patients fulfilling the criteria of diagnosis as per the proforma will be selected for the study.
- A clinical evaluation of patients will be done by collection of data through information obtained by history, physical examination, and laboratory tests.
- Review of literature will be collected from Post Graduate Library, Department of Kayachikitsa, Ayurveda Mahavidyalaya, Hubli, and from Authentic Research Journals, Websites, Digital Publications etc
- The data, which are obtained by the clinical trial will be statistically analysed by applying Students‘t’ test.
Inclusion Criteria:
Subjects fulfilling the following conditions were included:
- Male Subjects of age between 21 years to 45 years.
- Male subjects with sperm count below 20 million / ml.
Exclusion Criteria:
The following Subjects were excluded from the study:
- Subjects categorized under Azoospermia.
- Subjects with the past history of Mumps, Orchitis, Trauma.
- Subjects with history of diabetes, thyroid disorders, tuberculosis, vascular disorders, Testicular mal descent, previous reproductive organ surgery, S.T.D., HIV / AIDS, Hydrocele, CA – Testes.
- Subjects with uncontrolled metabolic disorders & other systemic disorders.
Parameters of Study:
Subjective Parameters:Parameters of assessment will be totally based on the changes in the clinical features of Ksheena shukra (Oligospermia) and improvement in Scoring Index of
DourbalyaShrama
MukhashoshaPandu
SadanaKlaibya
Shukra Avisarga
Objective Parameters:Objective parameters will be based on
1. Semen analysis.
Study Design:A Comparative Clinical Trial study.
Sample size:AMinimum of 30 cases diagnosed as Ksheena shukra (Oligo-spermia) will be selected incidentally and randomly categorized into two groups consisting 15 subjects in each group.
Group – A:Internally:
Koshta Shuddhi with Haritakyadi Choorna 5 to 10 gms for 2 to 3 days
Then Ashwagandhadi Choorna is administered for 60 days in the dosage of 5 gm twice daily
Group – B:Internally:
Koshta Shuddhi with Haritakyadi Choorna 5 to 10 gms for 2 to 3 days
Then Shatavaryadi Choorna is administered for 60 days in the dosage of 5 gm twice daily
Duration:2 months
Follow Up: 2 months
Assessment criteria
After assessing seminal parameters before and after treatment, the over all effect of the therapy will be assessed as under
(a)Conceived:Subjects who successfully conceive their wives after ………………………treatment.
(b)Complete Remission:76 to 100 percent improvements in sperm count.
(c)Markedly improved:51 to 75 percent improvements in sperm count.
(d)Improved:26 to 50 percent improvements in sperm count.
(e)Unchanged: Less than 25 percent improvements in sperm count.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly
YES
Investigations
1. Semen analysis (as per the guidelines of WHO (1993))
i.e. appearance, liquefaction time, volume, viscosity, Ph, Sperm count, sperm motility, sperm morphology and sperm viability
2. Blood: Hb%, TC, DC, ESR, RBS,
3. Urine: Albumin, sugar, Micro.
4. To exclude other disorders USG – Scrotum, Thyroid Profile, Tridot and VDRL will be done if necessary.
Interventions:
Group – A:The patients of this group will be givenAshwagandhadi Choorna internally.
Internal Therapy:Haritakyadi Choorna (For Koshtha Shuddhi)
Dose: 5 to 10 gms, Twice daily for 2 to 3 days
Anupana - Ushnodaka.
Ashwagandhadi Choorna
Dose – 5 gm
Kala – 2 times daily.
Anupana – Ksheera
Duration:2 months
Follow up:2 months
Group – B:The patients of this group will be givenShatavaryadi Choorna internally.
Internal Therapy:Haritakyadi Choorna (For Koshtha Shuddhi)
Dose: 5 to 10 gms, Twice daily for 2 to 3 days.
Anupana - Ushnodaka.
Shatavaryadi Choorna
Dose – 5 gm
Kala – 2 times daily.
Anupana – Ksheera
Duration:2 months
Follow up:2 months
7.4 Has ethical clearance been obtained from your institution in case of 7.3.
YES
Ethical clearance has been obtained by the ethical committee constituted by Ayurveda Maha Vidyalaya, Hubli, and written consent will be taken by each individual patient or by an attendant if the patient is illiterate, on a printed consent form.
[C] List of References:
(1)Dr. Shribhasakar Govindji Ghanekar, Sushrutha Samhita, Sutra Sthana, Vedomutpatti Adhyaya,5th Edition, Motilal Banarasi Das, New Delhi, PP-4, TP-812, 2002.
(2)Dr. Ravidatta Tripathi, Ashtanga Sangraha, Sutra Sthana, Ayush Kamiya Adhyaya, Punarmudrita Samskarana, Chaukhamba Sanskrit Pratishthan, New Delhi, PP-7, TP-683,2001.
(3) Jeffery S. Flier, Harrison’s Principles of Internal Medicine, 15th Edition, Volume-1, Mc Graw Hill, Newyork, PP-302-305, TP-1442, 2001.
(4)Lawrence. M. Tierney, Current Medical Diagnosis and Treatment, 35th Edition, A Lange Medical Book, U. S. A, PP-841-842, TP-1552, 1996.
(5)G.S. Sainani , API Text Book Of Medicine, 6th Edition, Published by Association of Physicians of India, Mumbia, PP-981, TP-1444, 1999.
(6)Dr. Brahmanand Tripathi, Charak Samhita, Sutra Sthana, Kiyanta Shirsiya Adhyaya, Punarmudrita Samskarana, Sanskrit Pratishthan, New Delhi, PP-351, TP-1052, 2002.
(7)Gujrat Rajya- Bheshaja Samiti, Bheshaja Samhita (Ayurvedic Pharmocopoeia), Rasoddhara Tantra, Publisher- Swasthya Mantralaya Gujrat Rajya, Ahmedabad, Ist Edition, PP-532, TP-912, 1966.
(8) Dr. Indra Dev Tripathi, Yogaratnakar, Uttara Khanda, Vajikarana Nidana-Chikitasa Prakarana, Krishana Das Academy, Varanasi, Ist Edition, PP-875, TP-894, 1998.
(9)Dr. Brahmanand Tripathi, Charaka Samhita, Chikitasa Sthana, Rasayana Adhyaya, Punarmudrita Samskarana, Sanskrit Pratishthan, New Delhi, PP-12, TP-1450, 2005.