RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

COMPLETED PROFORMA FOR THE REGISTRATION OF SUBJECT (BHAISHAJYA KALPANA) FOR THE DISSERTATION OF M.D. (AYURVEDA)

“PHARMACEUTICO - ANALYTICAL AND EXPERIMENTAL STUDY OF MADANAMODAKA W.S.R ITSVAJIKARANA EFFECT”

By

Dr.ROOPASRI K.V.

M.D.(Ayu) Scholar,

Dept. of P.G. Studies in Bhaishajya Kalpana,

A.L.N.Rao Memorial Ayurveda Medical College

Koppa, Karnataka.

Guide

Dr.DINESH KUMARMISHRA M. D. (Ayu.)

Professor H.O.D.

Dept. of P.G. Studies in Bhaishajya Kalpana,

A.L.N.Rao Memorial Ayurveda Medical College

Koppa, Karnataka.

2011-2012

A.L.N.RAO MEMORIAL AYURVEDA MEDICAL COLLEGE, HOSPITAL

AND P.G. RESEARCH CENTER

KOPPA

From,

Dr.Roopasri K.V.

M.D. (Ayu.) Scholar,

Dept. of P.G. Studies in Bhaishajya kalpana,

A. L.N. Rao Memorial Ayurveda Medical College,

Koppa, Karnataka

To,

The Registrar,

Rajiv Gandhi University of Health Sciences,

Karnataka, Bangalore.

Through Proper Channel

The Principal,

A.L.N.Rao Memorial Ayurveda Medical College

Koppa, Karnataka.

Subject: Submission of Completed Proforma for Registration of Subject

for Dissertation.

Respected Sir,

I request you kindly to register the below mentioned subject against my name for submission of dissertation to Rajiv Gandhi University of Health Science Bangalore, Karnataka as partial fulfillment of M.D. (AYU) Bhaishajya Kalpana.

Title of Dissertation

“PHARMACEUTICO - ANALYTICAL AND EXPERIMENTAL STUDY OF MADANAMODAKA W.S.R. ITS VAJIKARANA EFFECT”

Here with I am enclosing completed Proforma for registration.

Thanking you,

Yours Faithfully,

Place:

Date: Dr.ROOPASRI K.V.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA,

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME of the Candidate Dr. ROOPASRI K.V.

and ADDRESS: W/O SHREEDHAR S.K.

“SHREE GOKULA”

THYAGARAJA ROAD

KOPPA - 577126

CHIKMAGALUR DIST

2. NAME of INSTITUTION: A.L.N.RAO MEMORIAL AYURVEDIC

MEDICAL COLLEGE &

PG RESEARCH CENTRE

KOPPA-577126

3. COURSE of Study and SUBJECT: M.D. (Ayurveda) in

BHAISHAJYA KALPANA.

4. DATE of Admission to Course:2nd November 2011.

5. TITLE of the topic:

“PHARMACEUTICO - ANALYTICAL AND EXPERIMENTAL STUDY OF MADANAMODAKA W.S.R. ITS VAJIKARANA EFFECT”

6. BRIEF RESUME OF THE INTENDED WORK

6.1NEED FOR STUDY:

Acharya Vagbhata says in the braise of progeny, that the man without progeny is like a solitary tree that yields no shade, which has no branches, which bears no fruits and is devoid of any pleasant odor. It is to be regarded as a painted lamp, dried up lake or psuedometal which has only the appearance of the precious metal, and is like a man of straw processing only the shape of man1.

The etymology of word ‘Vajeekarana’ shows its origin from two Sanskrit words ‘vajin’ and ‘karanam’. The word Vajinmeans for horse and karanam means performing. The dictionary further details about the vajeekarana as those which stimulate or create desire. Sometimes it is related with horse like capabilities for sex. Maharshi Charaka has defined it as, “the factors which make a man capable of entering in to the sexual intercourse with women with stallion vigour, which makes him capable of performing excessive sexual intercourse”2.Sushruta has dealt Vajeekarana for those medicines, which by regular use make the man immensely potent like horse3.

Vajeekarana dravyas encourages the anabolic processes. When drugs with such qualities are compared with arousing or increase in sexual desire, the word is well related with medical terminology ‘aphrodisiac’. Therefore, Vajeekarana dravyas also limits to progeny as nature has given this beautiful treasure to keep the genetic makeup continued by offspring of specific species. Fast moving life-style has brought various physiological problems to general human beings and sexual problems are never apart from them. Premature ejaculation, impotency, erectile dysfunction etc. and other sexual disorders are commonly seen. The causes of them are said to be physical, social and psychological. The psychologists attribute these to fear, work load, inhibition, anxiety, etc. In Ayurveda also, it is very clearly said that the Shukra decreases due to Chinta, Jara, Vyadhi, Karmakarshana (exhaustion by overwork), kshaya etc4

Efforts are always made to satisfy the physical desires so that maximum attention towards the society build up can be given since long past. This practice is still practically needed. Hence, present study in these regards automatically becomes important. Present study is an effort to evaluate the Vajeekarana effect of Madana Modaka(a common drug practiced since long in Indian culture) through animal experiment.

Hypothesis :

  • Null-Hypothesis: The Madana Modaka may not act as Vajeekarana when administered internally.
  • Hypothesis: The Madana Modaka at a dose of 2gm (Human dose) administered internally, for Vajeekarana purpose will act better than at a dose of 6 gm and 12 gm respectively.

6.2 REVIEW OF THE LITETRATURE:

All related literatures from Ayurvedic and modern texts, journals, published materials etc. will be reviewed and screened to test the hypothesis mentioned. It will be dealt under 4 headings;

  1. Drug review
  2. Pharmaceutical review
  3. Analytical review
  4. Experimental review

1)Drug Review:

The formulation Madana Modaka is selected for the present study. Different literatures like Bruhatrayis, Laghutrayis, Nighantus along with modern texts and journals will be screened in regarded to trial drug and its ingredients.

2)Pharmaceutical Review:

Pharmaceutical review involves Vati Kalpana as per classical reference, will be screened and related aspects of study explained with any other pharmaceutical science will also be explored.

3)Analytical Review:

All the analytical procedures like physico-chemical, phyto-chemical and organoleptic tests will be reviewed.

4)Experimental Review:

Experimental review will be screened as per modern pharmacology. For the present study Beach and Stone 1940 method will be reviewed.

6.3OBJECTIVES OF STUDY

  • To bring the scattered literature on Madana Modaka under one umbrella.
  • To prepareMadana Modaka as per Bhaishajya Ratanavali.
  • To develop analytical standards for Madana Modaka.
  • To carry out experimental study to evaluate the effect of Madana Modaka as Vajeekarana.

7. MATERIALS AND METHODS:

7.1Source of data

This experimental study source of data will be grouped as below:

a)Literary Source

b)Pharmaceutical Source

c)Analytical Source

d)Experimental Source

a)Literary Source:

All relevant classical and modern literatures up to dateof work on Madana Modaka and its ingredients will be screened.

b)Pharmaceutical Source:

Genuine raw materials will be collected and screened. The formulation which is selected for the present study Madana Modaka will be prepared in the pharmacy attached to A.L.N.Rao Memorial Ayurvedic Medical College, Koppa.

c)Analytical Source :

Analytical studies will be conductedand data will be procured on Madana modaka from Quality Control Laboratory attached to A.L.N.Rao Memorial Ayurvedic Medical College, Koppa.

d)Experimental Source :

Experimental study will be conducted on male healthy albino rats which are maintained under standard animal varying conditions in the institutional animal house attached to A.L.N.Rao Memorial Ayurvedic Medical College, Koppa by Beach and Stone1940 method.

7.2METHOD OF COLLECTION OF DATA (Including sampling procedures if any)

  1. Pharmaceutical study :

Raw materials will be screened and data will be collected.

Preparation of Madana Modaka as per Bhaishajya Ratanavali text7.

Ingredients

Vijaya patra+beeja-1 part.

ShuntiKarkatashringi.Katphala.

Pippali.Kusta. Nagakeshara.

Maricha.Dhanyaka.Ajamoda.

Haritaki.Saindhava.Yavani. -1 part

Vibhitaki.ShatiYastimadhu.

Amalaki.Talisapatra.Methika

Shweta jeeraka.Krishna jeeraka.Twak.

ElaTejapatra.Karpoora.

Khanda Shrkara-2 parts(that of above Choorna)

Ghrita and Madhu-as required.

Procedure

The Vijaya patra and beeja are soaked in water for some times, removed from water and dried. After drying fried in ghrita and made into fine powder and allother ingredients are taken and made into fine powder. All the powders together mixed with the thread consistency of Khanda sharkra paka. This whole mixture is made in to semi solid state by heating. After attaining consistency of pill making, remove from fire and make it cooled, then Madhu and Ghrita is added as required quantity. Modaka is prepared out of it, in a size of asper dose mentioned..

  1. Analytical study
  1. General Description (Organoleptic Characters).
  2. Physico-chemical analysis:

a)Total Ash

b)Acid insoluble ash

c)Water soluble ash

d)Alcohol soluble extractives

e)Water soluble extractives

f)Tablet testing:

  1. Uniformity test
  2. Hardness test
  3. Friability test
  4. Disintegration test

3. Qualitative and Quantitative analysis:

  • Qualitative Analysis:

For primary and secondary plant metabolites.

  • Quantitative Analysis:
  1. Total Fat content
  2. Total Sugar
  3. Total Alkaloid contents
  1. Experimental study:

The Vajeekarana effect of Madana Modaka will be done on male Wister albino rats weighing 150-200 gms according to the Beach and stone 1940 method.

1 / Sample / 24 male healthy Wister albino rats will be selected.
2 / Inclusion Criteria / Healthy male Wister albino rats.
Weighing between 150-200 gms.
Sexually active male rats.
3 / Exclusion Criteria / Rats weighing below 150 and above 200 gms.
Diseased and infected rats.
Rats which are under trial for other experiments.
4 / Grouping / Each group contains 6 rats and will be kept in separate cages.
Grouping / No. of rats / Drug / Rat Dose/ 200gm body wt
Group I (As Control) / 6 / Distilled water / 2 ml/Rat
Group II (Dose at 2gms/Human dose)5 / 6 / Madana Modaka 2 gms/Human dose / 36mg/Rat Dose
Group III(Dose at 6gms/Human dose)6 / 6 / Madana Modaka 6 gms/Human dose / 108mg/Rat Dose
Group IV (Dose at 12gms/Humandose)7 / 6 / Madana Modaka 12 gms/Human dose / 216mg/Rat Dose
5 / Procedure /
  • From 2 weeks before screening tests the male rats will be housed individually at standard conditions
  • Male rats are trained for sexual behavior 2 times per day for a period of 10 days.
  • Among them sexually active rats are selected for testing aphrodisiac activity.
  • Trial drugs are made in to suspension form and administered according to dose mentioned.
  • Control group rats receive only distilled water.
  • Female rats are given with estrogen and progesterone as per dose.
  • Then the highly receptive female rats are introduced into trial male rat cages separately and each male rat is observed for copulatory behavior.
  • Similar procedure for control group also.

6 / Total duration /
  • The total duration of the treatment is 32days.
  • 2 weeks housed individually at standard conditions(15 days)
  • Male rats are trained for sexual behaviorfor 10 days.15 to 25th day)
  • Among them sexually active rats are selected for testing aphrodisiac activity.
  • Followed by administration of the selected dose of trial drug daily for sexually active rats and sexual behavior observed.(25 to 32nd day)

7 / Observation / After the administration of the selected dose of trial drug, the experimental rats will be closely monitored and their sexual behavior will be evaluated based on the following parameters.
  • Initial arousal period
  • Peak arousal period
  • Mounting behavior(No of attempts)
  • Refracting period or phase(Time interval to mount again)

8 / Statistical test / ‘Anova’ test and’ Dunnett’s t’ test12

7.3 Does the study require any investigations or interventions to be conducted on patient or other humans or animals? If so please describe briefly

Yes, the experiment will beconducted on male WisterAlbino rats under standard conditions(food, water and atmosphere etc) in the Animal house at A.L.N.Rao. Memorial Ayurvedic Medical College, Koppa, Chikmagalur Dist.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes, ethical clearance is obtained through the ethical committee formulated in this Institution and a necessary document, certificates has been enclosed.

8. REFERENCES :

  1. Acharya Vagbhata, Astanga Sangraha, English translation by Prof. R.K.Srikantha murthy, edition-1997, Choukambha Publications, Varanasi, Uttarastana, 50th chapter, Sloka No. 8, Page No. 522.
  2. Acharya Agnivesha - Charaka Samhita by Dr.Ramkaran Sharma with Chakradatta commentary , published by Choukambha Sankrit Series , Varanasi, Chikitsa stana, vol- III 2/4/51
  3. Acharya Sushrutha - Sushruta Samhita,English translation by Prof. K.R.Srikanta Murthy, Chikithsa Sthana, 26th chapter,vol. II,Sloka No.6, Page .No.250,
  4. Acharya Vagbhata, Astanga Sangraha, English translation by Prof. R.K.Srikantha murthy, edition-1997, Choukambha Publications, Varanasi, Uttarastana, 50th chapter, Sloka No. 12.
  5. Acharya Shri Vishwanath Dwivedi, Bharateeya Bhaishajya Kalpana Vignana, Practical Pharmacy in Indian medicine, Publication by Krishnadas Academy Varanasi,Page, No-284.
  6. Bhishagrathna, Kaviraj Govinda Dassen, Bhaishajya Rathnavali, Edited with Siddiprada,Hindi commentary by Prof. Siddhinandan Mishra, Publication by Choukambha Surabharathi Prakashan, Varanasi, 8th Chapter,Page.No. 269.
  7. Kaviraj, Shri Ambika datta Shastry, Bhaishajya Rathnavali,Publicatiopn by Choukambha Sanskrit Samstana, Varanasi, Sloka-162-170. Page No- 178.
  8. Dr.J.L.N.Shastry, Dravyaguna Vignana, Publication by, Choukambha Orientalia Varanasi, edition-2007, Vol-II and Vol-III.
  9. Vogel G.H.(1927), ‘Drug Discovery and Evaluation’ 2nd Edition, Springer, Berlin, Germany.
  10. Brian Everhitt, ‘Medical Statistics’, Cambridge University, U.K., Edition 2006.
  11. S.C.Gupta, ‘Fundamentals of Statistics’, Himalaya Publishing House,Mumbai, Edition- 2009.

9. Signature of the Candidate :

10. Remarks of the Guide:

11. Name and Designation of (In Block Letters) :

11.1) Guide:DR.DINESH KUMAR MISHRA,M.D (AYU)

PROFESSOR & HOD

DEPT.OF RASA SHASTRA &BHAISHAJYA KALPANA

FACULTY OF POST GRADUATE STUDIES,

A.L.N.RAO MEMORIAL AYURVEDIC COLLEGE,

KOPPA-577126,CHICKMANGLUR-DT, KARNATAKA.

11.2) Signature:

11.3) Co-Guide:Dr. h.ABDUL KAREEM M.D. (AYU),

LECTURER,

DEPARTMENT OF POST GRADUATE

STUDIES IN BHAISHAJYA KALPANA

A.L.N RAO MEMORIAL AYURVEDIC

COLLEGE & PG RESEARCH CENTRE

KOPPA-577126

11.4) Signature :

11.5) Co-Guide:

DR.PRASHANT KUMAR JHA,

C.I.P.R., D.I.M, P.G.D.E.E., M.Sc., Ph.D.

HEAD, QUALITY CONTROL LABORATORIES

A.L.N.RAO MEMORIAL AYURVEDIC COLLEGE,

KOPPA-577126, CHICKMANGLORE-DT,KARNATAKA

11.6) Signature :

11.7) Head of the Department: DR.DINESH KUMAR MISHRA,M.D (AYU)

PROFESSOR & HOD

DEPT.OF RASA SHASTRA & BHAISHAJYA KALPANA

FACULTY OF POST GRADUATE STUDIES,

A.L.N.RAO MEMORIAL AYURVEDIC COLLEGE,

KOPPA-577126, CHICKMANGLUR-DT, KARNATAKA

11.6 Signature :

12.

12.1 Remarks of Principal:

12.2 Signature :