FROM,

Dr. Radhakrishnan R

Preliminary M.D.(Ayu),

Department of Post Graduate Studies in Kayachikitsa,

S.D.M College of Ayurveda and Hospital,

Hassan -573201.

TO,

The Registrar,

Rajiv Gandhi University of Health Sciences Bangalore,

Karnataka.

THROUGH:

The Principal,

S.D.M College of Ayurveda and Hospital,

Hassan 573201

SUBJECT: Submission of completed proforma for registration of subject for dissertation.

Respected Sir,

I request you to kindly register the mentioned subject against my name for the submission of the dissertation to the Rajiv Gandhi University of Health Sciences Karnataka, Bangalore for partial fulfillment of M.D (Ayurveda).

Title of the Dissertation:

“A CLINICAL STUDY ON THE EFFECT OF AMALAKYADI YOGA IN THE MANAGEMENT OF KSHINASHUKRA WITH SPECIAL REFERENCE TO OLIGOASTHENOZOOSPERMIA”

Here with I am enclosing completed proforma of synopsis for registration of subject for dissertation.

Thanking you,

Yours faithfully

Date:

Place: Hassan (Dr. Radhakrishnan. R)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE- 2

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT OF DISSERTATION

  1. NAME OF CANDIDATE Dr. RADHAKRISHNAN. R,

AND ADDRESS: PRELIMINARY M.D (AYU)

SCHOLAR, DEPARTMENT OF

POST GRADUATE STUDIES IN

KAYACHIKITSA,

S.D.M COLLEGE OF AYURVEDA,

HASSAN.

PERMANENT ADDRESS: S/O MR. V. RAJA, RAGAVENDRRAS (H), H.S ROAD

KOOTHATTUKULAM, ERNAKULAM (DIS),

KERALA, 686662

2.NAME OF THE INSTITUTION: S.D.M COLLEGE OF AYURVEDA

AND HOSPITAL HASSAN, KARNATAKA.

3.COURSE OF THE STUDY M.D AYURVEDA

AND SUBJECT: (KAYACHIKITSA)

4.DATE OF ADMISSION: 29th November 2010

5.TITLE OF TOPIC: “A CLINICAL STUDY ON THE EFFECT OF AMALAKADI YOGA IN THE MANAGEMENT OF KSHINASHUKRA WITH SPECIAL REFERENCE TO OLIGOASTHENOZOOSPERMIA”

6. BRIEF RESUME OF THE STUDY

6.1NEED FOR THE STUDY:

Achievement of scientific integrity and credibility of the concepts can only be with well designed and conducted research studies. To create a healthy progeny is one of the foremost Dharma of an individual. So fertility is an existential necessity since the time immemorial.

Infertility, defined as the inability to conceive after at least one year of unprotected intercourse, affects about 8%-12% of all married couples. In about one third of these couples, male factor is the primary problem and in another one quarter, both the male and the female partner contribute to the infertility.1

Male infertility can be defined as an inability to induce conception due to defect in spermatic functions. The male partner carrying pathological semen reports include low sperm count, motility, abnormal forms and sperm functional tests and whose female partners have been ruled out for the possible etiological factors of infertility may be diagnosed under male infertility. Past decades have witnessed a remarkable decline infertility rates in the industrialized world.2,3

Idiopathic Oligoasthenozoospermia designated as an abnormality in the sperm count and the motility of the sperm, it accounts, for almost 24% of all male infertility.

Main function of Shukra Dhatu is reproduction. Kshina Shukra is a disease in which both quality and quantity of Shukra is reduced4 and may lead to infertility. In this context quality of Shukra refers to the motility of sperm and the quantity refers to the decreased sperm count. So Kshinashukra can also be correlated with Oligoasthenozoospermia.

Vajikarana offers wide range of drugs which help in correcting various pathologies of semen. Drugs having Madhura Rasa, Guru-Snigdha Guna, Vrishya, Shukra Vardhaka, Balya and Rasayana properties 5 has to be used for the treatment of Kshina Shukra.

Amalakyadi Yoga comprises of Amalaki, Guduchi and Gokshura possess Vrushya Guna and Rasayana Guna.

Gokshura: The fruits and different extracts and active constituents posses pharmacodynamic properties and uses as cooling, tonic, aphrodisiac, in painful micturation, urinary discharges and impotence and is C.N.S. stimulant6

Amalaki: Of all plant related species this fruit is believed to contain the richest supply of vitamin C known to man. vitamin C is very essential factor for the nourishment of sperm and also it is essential for optimising the condition for sperm motility

Guduchi: Its regular use helps to detoxify male reproductive system and rejuvenate it. Due to its adaptogenic and aphrodisiac properties, giloy helps to increase sperm count, sperm motility and erection time. It also acts as a sperm purifier.

This study is planned to check whether these drugs are really having any effect on the sperm count and sperm motility if administered as a combination.

6.2 REVIEW OF LITERATURE:

In Ayurveda, Sara of all Dhatus is considered as seventh Dhatu i.e. Shukra. The factor which is implanted for the formation of embryo is known as Shukra. This is composed of Vayu, Agni, Jala and Prthvi Mahabhuta in the state of their excellence. All these factors individually share one forth of the attributes of each of Mahabhuta. This is also shares all the six tastes.7

Shukra i.e., Retas or Rupadravya has some physical characters which can be attributed to both semen as well as sperms8,9,10 11,12such as: Sphatikabam, Dravam, Snigdam, Pichilam, Saram, Maduram, Madhugandha, Bahu / Bahala, Avidahi, Anutva,Phalavattata, Garbhakara.

The Shukra which is vitiated by Doshas is called Shukradushti i.e. the male factor responsible for male infertility.13

Sukra Dusti is classified into 8 types.14 The 8 types of Retodusti explained by Charaka in Sutrasthana15exactly overlap the Ashtavidha Shukra Dushti and hence, Shukradushti and Retodusti can be considered as synonyms. Symptoms include Phenila, Tanu, Ruksa, Vivarna, Puti, Picchila, Avasadi and Anya Dhatu Samsrshta.16The 8 types of Retodusti described by Susruta are Vatadushta, Pittadushta, Kaphadushta, Sonitadushta (Kunapa), Granthi, Putipuya, Kshina and Mutra Purisha Gandhi.13

Acarya Charaka has quoted male infertility (na casya garbhaha jayate) as a Lakshana and outcome of Shukrapradoshaja Vikara,17 besides certain sexual inadequacies and he has not mentioned any characteristic seminal findings. In clinical practice also Oligoasthenozoospermia cases present with infertility, no other sexual inadequacies like Klaibya, Aharsha etc. are practically found as part of Oligoasthenozoospermia.

Shukra can be considered as whole endocrine orchestra, (mainly androgens), semen with its subtle particles like sperms or both. Thus Oligozoospermia means the sperm count is less than 40 million/ml. and Asthenozoospermia the motility of spermatozoa is lower than 50% of active motile sperms.18 In Oligoasthenozoospermia both less number of sperm and low motility are found. Oligoasthenozoospermia has been included under Kshinashukra for the prupose of modern parlance, since Kshinashukra is both qualitative and quantitative vitiation of Shukra.

REVIEW OF PREVIOUS RESEARCH WORKS:

In recent and past many research works have been conducted in Ayurvedic institutions for revalidation and scientific evaluation of Ayurvedic principles and practices. In this regards more than 150 theses have been submitted on various topics of Vajikarana till today. The following works have been done in the management of Shukradushti with Ayurvedic drugs in different institutions.

  1. Ahuja P C (1992)-The role of Vajikarana in Shukradushti, PG Thesis, Dept of Kayachikitsa, IPGT&RA, GAU, Jamnagar.
  2. Singh, N G (1997) - A clinical study of Role of Shukrajanana and Shukra Shodhaka drugs in management of Shukradusti, PG Thesis, Dept of Kayachikitsa, IPGT&RA, GAU, Jamnagar.
  3. Raghuram A (1997) - A comparative study of Role of Baladi Vrishya Basti and Shatavaryadi Yoga in the management of Kshina Shukra, PG Thesis, Dept of Kayachikitsa, IPGT&RA, GAU, Jamnagar.
  4. Rao N A (1997)-The role of Shukra Janak and Shukra Sodhak drugs in the management of Shukradushti, PG Thesis, Dept of Kayachkitsa, IPGT&RA, GAU, Jamnagar.
  5. Gauda Chandrashekhar (1998) - Study of Amalakyadi Yoga in Shukralpata, PG Thesis, Dept of Kayachikitsa, r. B R K R Government Ayurvedic College, Hyderabad.
  6. Prasad Srinivas (1998) -The role of Suvarna Bhasma and Vajikarana drugs in the management of Shukradushti, Ph D Thesis, Dept of Kayachikitsa, IPGT&RA, GAU, Jamnagar.
  7. Shivakumar N (1998)-Effect of Kokilaksa Beeja on Shukradushti w.s.r. to Oligozoospermia, PG Thesis, Dept of Kayachikitsa, Govt Ayurvedic Medical College, Mysore. University of Mysore.
  8. Soni H N (1998)-The role of Amlaki Rasayana in the management of Shukradushti w.s.r. to Asthenozoospermia, PG Thesis, Dept of Kayachikitsa, IPGT&RA, GAU, Jamnagar.
  9. Anup.B.Thakar (2000)-The role of Suvarna Bhasma and Kokilaksha in the management of Kshina Shukra, Ph D Thesis, Dept of Kayachikitsa IPGT&RA, GAU, Jamnagar.
  10. Girish K.J (2002)-The role of Shukra Shodana-Janana yoga in the management of Kshinashukra, PG Thesis, Dept of Kayachikitsa, Govt Akhandanand Ayurved College, Ahmedabad. GAU, Jamnagar.
  11. Ajith kumar (2003)-Pharmaceutical study of Vanari Gutika w.s.r. to Oligoasthenozoospermia,PG Thesis, SDM College of Ayurveda, Udupi, RGUHS, Bangalore.
  12. Pujari Nagraj (2004)-The role of Ashwagandha in the management of Kaphaj Shukradushti, PG Thesis, Dept of Roga Nidana, IPGT&RA, GAU, Jamnagar.
  13. Jeevan G (2004) A comparative pharmacotherapeutic study on Ksheera Vidari in Shukradushti, Udupi, PG thesis, SDM College of Ayurveda, Udupi, RGUHS, Bangalore.

In present study, scholar has planned to conduct clinical trial on Amalakyadi Yoga in patients of Kshina-Shukra with reference to oligasthenozoospermia. Details pharmacodynamics of Amalakyadi Yoga are as follows.

PROPERTIES OF AMALAKI, GUDUCHI & GOKSHURA19

6. 3AIMS AND OBJECTIVES:

Keeping in consideration of above mentioned facts, the present clinical trial will be carried with following aims and objectives.

To evaluate the efficacy of Amalakyadi yoga on various seminal and clinical parameters with special reference to the management of Kshina Shukra Oligoasthenozoospermia

7MATERIALS AND METHODS:

7.1 Source of data:

Established cases of Oligoasthenozoospermia from Vajikarana unit of Kayachikitsa department, SDM College of Ayurveda and Hospital, Hassan as well as cases referred by other physicians of other departments will be included in this study. Written consent will be obtained from such patients.

7.2Method of collection of data:

A.Diagnostic criteria:

The sperm count < 40 mill/ml20,21 and motility < 50% SLP + RLP18 will be considered as Oligoasthenozoospermia.

B.Inclusion criteria:

(1) Male partner with at least one year infertility with availability of the female partner’s clinical fertility data.

(2)A minimum of two semen analysis at an interval of 6 weeks showing oligasthenospermia (sperm count <40 million per ml,20,21 total sperm count of <40 million per ejaculate and rapid+ slow motility<50%) according to WHO criteria18.

C.Exclusion criteria:

1.Varicocele, accessory sex gland infection, testicular maldescent, previous reproductive organ surgery, and sexually transmitted diseases will be excluded.

2. Patients categorized under azoospermia will be excluded

3. Past history of mumps, orchitis, trauma, addictions, and acute febrile illness will be taken into account

  1. Diabetes, thyroid disorders, tuberculosis, vascular diseases, and any long-standing infection will also be taken into consideration.

D.Method of Semen Analysis:

Semen analysis of patients will be carried out by the scholar himself as per the recommended standards of semen examination by WHO (1993)18 for diagnosis and assessment of effect of therapy.

Collection of the ejaculate:

Abstinence:

The semen samples will be collected after a minimum of 3 days but not longer than 5 days of sexual abstinence.18

Method of collection:

Sample will be obtained preferably by masturbation. If patient is unable to produce the sample by masturbation, penile vibrator will be provided and applied. Where particular circumstances prevent collection of sample by above mentioned methods, patients will be advised to use special silastic condom during coitus, which helps in semen collection.

Semen Examination:

Examination of following parameters of semen sample will be carried as per the guidelines of WHO (1993)18.

1. Appearance7.Sperm count

2. Liquefaction time8.Sperm morphology

3. Volume9. Sperm viability

4. Consistency10.Debris material

5. pH 11.Amorphous matter

6. Fructose12.Auto-agglutination

E.Research design:

30 patients of Kshina shukra with will be selected from the outpatient department and will be given Amalakyadi yoga in the form of tablet administered in the dose of 4 tablets of 500 mg thrice daily, with a glass of lukewarm water, half an hour after food for 45 days. Thereafter the patients will be put on placebo for 45 days and semen analysis will be repeated on 90th day.

Procedure:

S No / Name of Drug / Botanical Name / Part Used / Quantity
1 / Gokshura / Tribulus terrestris / Panchanga / 1 part
2 / Guduchi / Tinospora cordifolia / Kanda Twak (stembark) / 1 part
3 / Amalaki / Embelica officinalis / Phala Twak / 1 part

Each one part of raw drugs i.e. Gokshura, Guduchi, Amalaki will be taken and authenticated from Dept of Dravyaguana, SDM College of Ayurveda, Hassan

To reduce the dose and for ease of administration, Amalakyadi yoga will be given Bhavana with its Kashaya and made into form of tablets each of 500 mg.

Method of fortification and tablet preparation:

Collected dried raw drugs will be powdered in SDM Teaching Pharmacy, Hassan. Sukshma choorna and kwathachoorna will be prepared and kwatha will be prepared out of the kwatha choorna by adding 8 parts of water to 1 part of choorna and reduce to 1/4th. After preparing kwatha, bhavana will be given to the sookshma churna with quantity sufficient of kwatha (quantity sufficient) for 7 times and then it will be dried and tablets will be made each weighing 500mg and preserved in air tight bottles.

Dose, Duration and Anupana, Diet :

Patients of Kshinashukra will be administered 6 gms (12 tablets each 500mg) of medicine in divided doses (4 tablets thrice daily) along with warm water after food for 45 days. Patients will be advised to follow their regular diet.

1. Patients will be put on placebo capsule of Bhrista Godhuma (fried wheat powder) in the dose of 500mg twice daily for next 45 days for further follow up, after withdrawal of the drug.

2. Semen analysis will be done on 45th and 90th day.

CRITERIA OF ASSESSMENT OF EFFECT OF THERAPY:

Assessment of effect of therapy on Oligoasthenozoospermia patients will be done on the basis of changes in seminal parameters.

Assessment of Seminal parameters:

Assessment of effect of therapy will be done on the basis seminal parameters observed before and after completion of therapy.

Statistical Methods

The present study is an outpatient based clinical trial with pre and post test design. The data collected during clinical study will be tabulated and statistically analyzed using Student ‘t’ test. The changes observed with p<0.05 will be considered as significant.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION? : YES

8. LIST OF REFERENCES:

  1. World Health Organization. Infertility: a tabulation of available data on prevalence of primary and secondary infertility. Geneva, WHO, Programme on Maternal and Child Health and Family Planning, Division of Family Health. 1991
  2. Kaufman RB, Spitz AM, Strauss LT, Morris L, Santelli JS, Koonin LM, Marks JS, The decline in in US teen pregnacny rates, 1990-1995, Pediatrics, 1998, 102, 1141-1147
  3. Pearce D, Cantisani G and Laibonon A, Changes in fertility and family size in Europe, Popul Trend, 1999, Spring, 33-40
  4. Dalhana, Susruta Samhita, with Nibandhasangraha Commentary of Dalhana and Nyayacandrika Panjika of Gayadasa on Nidanasthana, edi. from the beginning to the 9th Adhyaya of Cikitsasthana by Yadavji Trikamji Acharya and the rest by Narayan Ram Acharya, Varanasi, Caukhambha Orientalia, 2005, Sutrasthana, 1: 9 Teeka.
  5. Vagbhata, Ashtangahrdaya, Sarvangasundara of Arunadatta and Ayurvedarasayana of Hemadri commentaries, edi. by Pt. Hari Sadasiva Shastri , Varanasi, Chaukhambha Surbharati Prakashana, 2007, Sharira Sthana, 1:14
  6. Chakraborty, B; Neogi N.C. Pharmacological properties of Tribulus terrestris Ind. J. Pharm. Sci., 1978: 40; 50-52.
  7. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Sharira Sthana 2:3-4.
  8. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Chikitsa Sthana, 2:4:48.
  9. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Chikitsa Sthana, 30:145.
  10. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Sharira Sthana, 2:32.
  11. Sushruta, Susruta Samhita, with Nibandhasangraha Commentary of Dalhana and Nyayacandrika Panjika of Gayadasa on Nidanasthana, edi. from the beginning to the 9th Adhyaya of Cikitsasthana by Yadavji Trikamji Acharya and the rest by Narayan Ram Acharya, Varanasi, Caukhambha Orientalia, 2005, Sharira Sthana, 2:12.
  12. Vriddha Vagbhata, Ashtanga Sangraha with the SasilekhaSanskrita commentary by Indu, edited by Dr. Sivprashada Sharma, Varanasi, Caukhambha Sanskrita series office, 2006, Sharira Sthana, 1:4.
  13. Sushruta, Susruta Samhita, with Nibandhasangraha Commentary of Dalhana and Nyayacandrika Panjika of Gayadasa on Nidanasthana, edi. from the beginning to the 9th Adhyaya of Cikitsasthana by Yadavji Trikamji Acharya and the rest by Narayan Ram Acharya, Varanasi, Caukhambha Orientalia, 2005, Sharira Sthana, 2:3.
  14. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Chikitsa Sthana, 30:139.
  15. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Sutra Sthana, 19:4 (1).
  16. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Sutra Sthana, 19:3.
  17. Agnivesha, Caraka Samhita, English translation by Sharma PV, Varanasi , Caukhambha Orientalia, 2008, Sutra Sthana, 28:18-19
  18. World Health Organization, WHO Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction.3rd edi., Cambridge, Cambridge University Press, 1992.
  19. Sharma PV, Dravyaguna Vijana; Vol. I and II, 13th edition, Varanasi, Chukhamba Bharti Academy, 1992.
  20. Skandhan KP, Mazumdar BN. Interdependence of count and motility of spermatozoa. Acta Eur Fertil 1983; 13: 49-54.
  21. Amelar RD, Dubin L, Walsh PC, Male Infertility, Philledelphia, Sauders, 1977.

9. SIGNATURE OF CANDIDATE:

10. REMARKS OF THE GUIDE:

11. NAMES AND DESIGNATION OF:

. GUIDE : Dr. Girish KJ M.D (Ayu), Ph D,

Reader, Department of P.G Studies in Kayachikitsa

S.D.M.C.A. & H, Hassan, Karnataka.

11.2 SIGNATURE :

11.5 H.O.D : Dr. Muralidar P Pujar M.D (Ayu), Ph D,

Professor and HOD,

Department of P.G Studies in Kayachikitsa

S.D.M.C.A. & H, Hassan, Karnataka.

11.6 SIGNATURE :

12. REMARKS OF THE

CHAIRMAN AND PRINCIPAL:

12.1 SIGNATURE :