RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

“A COMPARATIVE PHARMACEUTICO - ANALYTICAL AND EXPERIMENTAL EVALUATION OF TILA KSHARA AND TILADI KSHARA W.S.R TO ASHMARIGHNA PROPERTY”.

By,

DR. KARTHIK H.V.

B.A.M.S.

POST GRADUATE DEPARTMENT OF BHAISHAJYA KALPANA,

A. L.N.RAOMEMORIALAYURVEDICMEDICALCOLLEGE

AND P.G. CENTRE, KOPPA-577126

GUIDE:

DR.BIMAL DEV MISHRA. M.D. (Ayu)

PROFESSOR, P.G. DEPARTMENT OF BHAISHAJYA KALPANA

A.L.N.RAOMEMORIALAYURVEDICMEDICALCOLLEGE

AND P.G. CENTRE,

KOPPA, KARNATAKA – 577126

2009-2010

RAGHIVGANDHIUNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE.

ANNEXURE - II

PERFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.Name of candidate and address : DR KARTHIK H.V.

S/o. VASUDEVA .H.S.

HERATEGADDEVILLAGE

KALKERE POST, KOPPA TALUK

CHIKMAGALUR - 577123

KARNATAKA

2.Name of the institution : A.L.N.RAO MEMORIAL AYURVEDIC

MEDICALCOLLEGE AND P.G.CENTER,

KOPPA,CHIKMAGALUR—DIST

KARNATAKA –577126

3.Course of study and subject : AYURVEDA VACHASPATHI

M.D. (AYURVEDA)

(BHAISHAJYA KALPANA)

4.Date of admission to course : 1stJUNE 2009

5.Tittle of Topic : “A COMPARATIVE PHARMACEUTICO -

ANALYTICAL AND EXPERIMENTAL

EVALUATION OFTILA KSHARA AND

TILADIKSHARAW.S.R TO

ASHMARIGHNA PROPERTY”.

6.BRIEF RESUME OF THE INTENDED WORK

6.1Need of the study:-

Mutrashmari is one among the Mahagadha as mentioned in our classical treatises1,2. The phenomenon of ashmarisanghatana and there line of treatment has been clearly explained in our texts.

Urinary calculi is one of the most common disease of the urinary tract. Urinary stones have plagued human beings since the earliest civilization.Urolithiasis can be correlated to Mutrashmari and it is a global problem. The incidence of calculi varies as per geographical distribution, sex and age group. The highest incidence of calculi occurs between the age of 30 and 50 yrs, the male and female ratio is 3:1.It has been estimated that 5% of global population suffer from urinary calculi5.

Acharya Sushruta says that before going for surgical procedures one should try to manage with oral medications like Ghrita, Taila, and Kshara etc.3

Tila kshara(Trail drug I)is one of such preperation, which seems to be effective in Ashmari. Tiladi kshara (Trail drug II) is another formulation which is found in yogaratnakara under Ashmari chikithsa4. An attempt has been made to compare ashmarighna property of Tila kshara and Tiladi kshara.

With an hypothesis that the kshariya guna of the drug may be effective in ashmari bhedana. The present study is taken to evaluate the Ashmari bhedana effect experimentally.

6.2REVIEW OF THE LITETRATURE :

In order to test the above mentioned hypothesis of Tila kshara and Tiladi Kshara, relevant literature will be reviewed and recorded under proper heading. The review of literature will be dealt under three topics.

  1. DISEASE REVIEW:-

Thorough screening of classical Ayurvedic texts, bearing the mentioning in relation with the disease will be reviewed and recorded. Few of the classics to be reviewed are Charaka samhita, Sushruta samitha, Astanga hrudaya, Yogaratnakara etc.

Contemporary texts, previous works, journals, magazines etc also will be reviewed for relevant information.

2. Drug Review :

  • The drug for the present study is Tila kshara and Tiladi Kshara taken from Yoga ratnakara.
  • The trail drug I contains stem(nala) of Tila(Sesamum indicum).
  • The trial drug II contains
  • Tila - Sesamum indicum
  • Apamarga- Achyranthes aspera
  • Kadali- Musa paradisica
  • Palasha- Butea monosperma
  • Yava- Hordeum vulgare
  • Contemporary texts, previous works, journals, magazines, internet, etcwill be reviewed.
  • Different classics along with nigantus will be reviewed for properties, mode of action, therapeutic values of the drug, to update the information on the topic.
  1. Pharmaceutical review :

The pharmaceutical process involved in the study is kshara kalpana. Various classics will be screened for thedescription.

6.3AIMS & OBJECTIVES OF STUDY

 Aims of the study is “EXPERIMENTAL EVALUATION OF ASHMARIGNA PROPERTY WITHTILA KSHARA AND TILADI KSHARA.” by Vermeuler technique.

Objectives of study:

To prepare theTila kshara and Tiladi kshara as per classical references.

To evaluate the trial drugs Tila Kshara and Tiladi kshara phytochemically.

To evaluate the Ashmarigna property of trial drug I (Tila kshara) and trail drug II (Tiladi kshara) experimentally.

  1. MATERIALS AND METHODS :

SOURCE OF DATA :

The material and method of the works are restricted to the following source

Pharmaceutical source.

Analytical source .

Experimental source.

PHARMACEUTICAL SOURCE

As per classical reference paneeya kshara will be prepared in the pharmacyattached to A.L.N.RAO MEMORIAL AYURVEDIC.MEDICAL COLLEGE AND PG CENTRE,KOPPA.

ANALYTICAL SOURCE :

  1. Organoleptic parameters
  2. Physico chemical analysis.
  3. Qualitative estimation of various secondary metabolites.
  4. Quantitavive estimation like Na, K, Ca etc.

Will be carried out in quality control lab of A.L.N.RAO.MEMORIAL AYURVEDIC MEDICAL COLLEGE AND PG CENTRE,KOPPA.

EXPERIMENTAL SOURCE

This being an experimental study albino rats will be the source, which are maintained under standard conditions in the animal house attached to A.L.N.RAO.MEMORIALAYURVEDICMEDICALCOLLEGEANDPG CENTRE,KOPPA.

METHOD OF COLLECTION OF DATA (Including sampling procedures )

18 male albino rats will be selected randomly as per below mentioned criteria.

INCLUSIVE CRITERIA :

  • Healthy male albino rats.
  • Weight --- 150 to 200 gms.

EXCLUSIVE CRITERIA

  • Rats weighing below 150 gms & above 200 gms, infected rats are excluded.

GROUPING

Each group contains 6 rats & will be kept in separate cages.

Sl.
no / Grouping / No of
rats / Drugs / Dose/
200 gms .wt / Purpose
1 / control group / 6 / distilled water / 2 ml / to serve as prophylactic control
2 / Trial drug I / 6 / Tila kshara / 4.5 mg / to bring about ashmari bhedana effect.
3 / Trial drug II / 6 / Tiladi Kshara / 4.5 mg / to bring about ashmari bhedana effect.

PROCEDURES :

The experiment will be carried out by following technique developed by Vermeuler (1950). First operative procedures are to be carried out. After anaestetising the rats with ketamine, a vertical incision measuring less than 1 cm is to be made over the suprapubic area in the middle, above the roof of penis. Bladder is identified and a small incision (30mm) will be made, and sterilizedZinc bed (10mg) is inserted and Bladder is closed. During treatment rats are supplied with normal diet and water for seven days. From eighth day trial drugs I and IIwill be administered assuring that in 7 days mutrashmari will be formed.45mg of trial drug will be added with 10ml of suitable solvent and mixed well thus 1ml suspension may contain 4.5mg of trial drug approximately. So 1ml of the suspension will be administered for rats as single dose. Thedrug is administered for the next 21 days, then the Bladder should be operated and the formed stones will be taken and weighed.

DURATION OFSTUDY: 1 month

OBSERVATION:

After 21 days of drug administration, rats are to be sacrificed. The formed stones are to be weighed. The differences in weight of zinc beds before insertion and after treatment are to be noted. The obtained data’s will be subjected to statistical analysis.

STATISTICAL TESTS

Appropriate student’s ‘t’ test and ‘f’ test.

7.2DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTION TO BE CONDUCTED ON PATIENT OR OTHER HUMAN OR ANIMAL ?IF SO PLEASE DISCRIBE BRIEFLY.

Yes, this being an experimental study, to be conducted on healthy male albino rats that are maintained on standard food and water. Intervention is necessary to insert the zinc bed into the bladder, using the technique developed by Vermeuler (1950) .

7.3HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 ?

Yes, clearance has been obtained through the ethical committee formulated in the institution.

  1. REFERENCE :

1)Acharya Sushruta, Sushruta Samhita, English translation by K.R Srikantha Murthy, Varanasi,chaukhamba orientalia, 2nd edition 2004, Sutrasthana, 33/4, 233pp.

2)Acharya Vagbhata, Ashatanga hridaya, Reprinted edition, Varanasi, KrishnaDasAcademy, 2000, Nidana Stana – 8/30.

3)

4)Sushruta: Sushrutha Samhita Nibandha Sangraha commentary by Dalhanacarya, Chaukhambha orientalia Varanasi 7th edition.Chikitsasthana: 7: 27

5)Acharya Yogaratnakara Uttarardha, Ashmari chikitsa Tila Kshara yoga and Tiladi Kshara yoga, Vidyathina Hindi Tika Sahitha translated by Dr Lakshmipatthi Shastry, Varanasi, Published by Chaukhamba series, Edition 2004.83pp

6)Mann charles V.,Russel R.C.G.,Williams N.S.-Bailey and love’s short practice of

surgery,The urinary bladder,ELBS with Chapman and Hall,1992,spain,21st

Ed;1336 .

9. Signature of the Candidate :

10. Remarks of the Guide:

1