RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

AN EXPERIMENTAL STUDY ON THE HEPATO-PROTECTIVE

ACTIVITY OF DRONAPUSHPI PANCHANGA (Leucas aspera Spreng)

By

Dr.SHILPA HIREMATH

Dept .of P.G.Studies in DRaVYA GUNA

S.D.M.COLLEGE of Ayurveda

HASSAN.

GUIDE

Dr. PRADEEP M.D (AYU)

LECTURER

Dept.OF P.G.Studies in DRAVYA GUNA

S.D.M.COLLEGE of Ayurveda

HASSAN

CO-GUIDE

Dr. RAVISHANKAR

M.Sc.Ph.D (PHARMACOLOGY)

S.D.M CENTRE FOR RESEARCH IN AYURVEDA

AND ALLIED SCIENCES, UDUPI.

2011 - 2012

S.D.M.COLLEGE OF AYURVEDA

THANNIRUHALLA, HASSAN-573201

From:

Dr. SHILPA HIREMATH.

Preliminary M. D. (Ayu) Scholar.

Dept. of Post Graduate Studies in Dravya guna,

S.D.M. College of Ayurveda & Hospital,

P.O. Box 164, Hassan – 573201.

To,

THE REGISTRAR,

Rajiv Gandhi University of Health Sciences

4th T block, Jayanagar, Bangalore-41, Karnataka.

Through,

The Principal and

Head of the Dept. in Dravya guna,

S.D.M. College of Ayurveda & Hospital, Hassan.

SUB: Submission of the completed Performa for registration of subject for

Dissertation

Respected Sir,

I request you to kindly register synopsis on below mentioned subject against my name for the submission of dissertation to Rajiv Gandhi University of Health Sciences, Karnataka, and Bangalore for partial fulfillment of postgraduate course in the specialization ofDravyaGuna M.D. (Ayurveda).

TITLE OF DISSERTATION

AN EXPERIMENTAL STUDY ON THE HEPATO-PROTECTIVE ACTIVITY OF DRONAPUSHPI PANCHANGA (Leucas aspera Spreng)”

Here with I am enclosing the complete Performa for registration of subjectfordissertation.

Thanking You,

Yours faithfully

Place: Hassan

Date: Dr.SHILPA HIREMATH

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA

BANGALORE.

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE : Dr.SHILPA HIREMATH

AND ADDRESS Preliminary M.D Scholar

Department of Dravyaguna

S.D.M. College of Ayurveda

Hassan -573201

Karnataka.

PERMANENT ADDRESS : Dr.SHILPA HIREMATH

D/O S.A.Hiremath.H NO-18

Adhyapak Nagar, Opp sub jail

HUBLI-580032

2. NAME OF THE INSTITUTE : SDM COLLEGE OF AYURVEDA,

HASSAN, KARNATAKA.

3. COURSE OF STUDY : AYURVEDAVACHASPATHI (M.D.)

IN DRAVYAGUNA

4. DATE OF ADMISSION : 29-10-2011

OF COURSE

5. TITLE OF THE TOPIC : “ANEXPERIMENTAL STUDY ON

THE HEPATO-PROTECTIVE

ACTIVITY OF DRONAPUSHPI

PANCHANGA(Leucas aspera

Spreng)”

6. BRIEF RESUME OF INTENDED WORK:

6.1 NEED FOR STUDY

Dronapushi (Leucas aspera Spreng) of Lamiaceae family1 is found throughout country as a weed 2,easily available, less cost effective and have been described in various Nighantus.Different pharmacological actions like Shopha, Kamala, Tamakashwasa and Kasajit are mentioned in Kaiyadeva Nighantu and Bhavaparkasha Nighantu.Indication in Kamala is seen in Kaiyadeva Nighantu, Bhavaparkasha Nighantu, Cakradatta and Vrinda Madhava. Cakradatta and Vrinda Madhava have described to use it in the form of Anjana in Kamala3, thus indicating its Hepatoprotective property.

About 20,000 deaths found every year due to liver disorders. The herbal drugs have shown the abilityto maintain the normal functional status of the liver with or without fewer side effects4. About 80% of the world populations rely on traditional medicine which is predominantly based on plant material5. Hence present studyof evaluating Hepatoprotective activity of Dronapushi has been taken up.

6.2REVIEW OF LITERATURE

Botanical Name: Leucas aspera Spreng.Family: Lamiaceae6

Acharya Bhavaprakasha has described Dronapushpi having Kamalajit property7. Same pharmacological activities also supported by Kaiyadeva Nighantu8. So, all the above said references are indicating that Dronapushpi possesses Kamalajit property.Dronapushpi has Katu, Lavana, Madhura rasa, Guru, Ruksha, Tikshnaguna, Usna Virya & Madhura Vipaka. It isKapha-Vatashamaka& has many Karma likeShothaghna, Kamalajit, Jwaraghna, Rechaka, Bhedana, Deepana, Anulomana, Krimighna, Kaphaghna, Vishaghna, Artavajanana, Swedajanana 9, 10, 11, 12, 13. Its chemical constituents are Laballenic acid, B-sitosterol and its Glucoside14.

Liver has a wide range of functions, including detoxification, protein synthesis and production of biochemicals necessary for digestion and synthesis as well asbreakdown of small and complex molecules, many of which are necessary fornormal vital functions.Hepatic disease (Liver disease) is a term for a collection of conditions, diseases and infections that affect the cells, tissues, structures or functions of the liver15. Liver diseases are mainly by toxic chemicals, excess consumption of alcohol, infections and auto immune disorders.Most of the hepato-toxic chemicals damage liver cells mainly by lipid per oxidation and other oxidative damages.

Liver is the most important organ where drugs are structurally altered; resulting biologically inactive or active metabolites and some of these are toxic. Liver is exposed to drugs in higher concentration as whole of the drug pass through liver to reach systemic circulation.Thus, the liver is vulnerable target of injury from various chemicals and drugs and disordered hepatic function is an important cause of abnormal drug handling16. Classical symptoms of liver disease includes nausea, vomiting, right upper quadrant abdominal pain & jaundice (yellowish discoloration of skin, mucus membranes or eyes due to elevated bilirubin concentrations in blood stream) associated with fatigue, weakness & weight loss17.

Kamala means it is a disease in which all likes and dislikes disappear18. Yellowish coloration of eye balls, skin, face, nail and urine associated with constitutional features like loss of appetite, weakness19, such clinical condition is called Kamala.

Previous works done

1.  SadashivRao – A clinical study of Dronpushpi Phanta on Shakhashrita Kamala. (B.K.R Govt College, Hyderabad,1985)20.

2.  Agraval K.K. – Role of Dronapushi on Vishamajwara.(M.M.M GovtCollege,Jaipur, 1995)21.

3.  Sharma Rajesh – A clinical study of Dronapushpi on Tamakashwasa. ( K.G.M.P College,Mumbai,1997)22.

4. K R Ashwini- Comparative evaluation of anti-inflamatory activity of Dronapushpi (Leucas aspera Spreng) swarasa and kwata on Albino rats. (Shri B.M.K Maha vidyalaya, shahpur, Belgum-2008)23.

Review of previous research works on liver

More than 19 researches have been carried till now on Hepato-protective activity of various drugs like Kalamegha, Haridra, Pippali, Bhringaraja, Rohitaka, Guduchi, Kasani, Udumbara, Bhoomyamalaki etc

6.3 OBJECTIVES OF STUDY

·  To evaluate the hepato-protective activity of Dronapushpi Panchanga churna in animal model

·  To Study the Pharmacognostic Phyto-chemical evaluation of collected sample of Dronapushpi and Phytochemical evaluation of churna.

7. MATERIALS AND METHODS

7.1 Source of Data

1. Collection of “Dronapushpi” (Leucas aspera Spreng.) from its natural habitat

2. Source of animal: From well-established animal house attached to S.D.M Centre for Research in Ayurveda and Allied Sciences, Udupi, Karnataka.

7.2 Method of collection data

1. Panchanga of Dronapushpi will be collected from the natural habitat.

2. Dronapushpichurnais prepared as per the classical References24.

3. Qualitative confirmation through simple instrumental techniques.

4. Wistar Albino rats will be divided into Control, Standard and Treatment Group (n=06s in each group).The test drugs, water and reference drug will be administered for 10 days and the two doses of the toxicant-Paracetamol will be administered orally to each group except the water control group on two alternate days i.e. 7th and 9th day 1st hour after test drug administration.

Study Design

A) Identification, Authentication of “Dronapushpi” & Collection

B) Collected samples of “Dronapushpi” (Leucas aspera Spreng.)

Will be subjected to following procedure

i)  Pharmacognostic study of “Dronapushpi”.

a)  Macroscopic Study

b)  Microscopic Study

ii)  Physicochemical study of “Dronapushpi”

a)  Moisture content

b)  Ash value

c)  Acid soluble/insoluble ash

d)  Water soluble/insoluble ash

iii)  Different solvent extraction

a)  Aqueous extract

b)  Alcoholic extract

iv)  Qualitative analysis by instrumental method

a)  T.L.C.

b)  H.P.T.L.C

v) Organoleptic & Preliminary phytochemical analysis of churna.

C) Animal study will be conducted as follow

i)  Dose Fixation – based on Paget and Barnes (1964) formula involving body surface area ratio, human dosage will be converted into animal dosage25.

.

ii)  Healthy Wistar Albino rats weighing between 140-200 grams will be procured and will be maintained in laboratory condition with normal diet and water for 3-5 days and divided into 6 groups each group containing 06 animals

01 / Group 01 / Control group –Distilled water with gum acacia will be given.
02 / Group 02 / Paracetamol control
03 / Group 03 / Reference Silymarin.
04 / Group 04 / Dronapushpi churna(Therapeutic dose)
05 / Group 05 / Dronapushpi (Half dose)
06 / Group 06 / Dronapushpi(Double dose)

D) Exclusion criteria

Ø  Wistar Albino rats which are infected and pregnant will be excluded from the study.

Ø  Wistar Albino rats showing signs of infection during the course of study and those under other experiments will be excluded.

E) Inclusion criteria

Ø  Healthy Wistar Albino rats of either sex.

Ø  Wistar Albino rats weighing between 140-200 gm.

Route of Administration: Oral Route

a) The toxicant Paracetamol will be administered orally to induce Hepato-toxicity.

b)Treatment schedule

Each rat in test group will be given test drug one hour before being subjected to Hepato-toxicity.

c)Observation

After 48hrs of the 2nd dose of Paracetamol, all the animals will be sacrificed by cervical dislocation and blood will be collected by severing carotid artery. The serum will be separated; liver weighed and liver homogenate will be prepared for different biochemical estimation. Liver will be preserved in10% formalin for its Histopathological processing.

Results will be analyzed by statistical method (ANOVA test with Dunnet’s multiple‘t’ test as post hoc)

7.3 Does the study require any investigations or interventions conducted on animals, patients or humans? (If so describe briefly)

-Serum Biochemical Estimation.

-Tissue Homogenate for Biochemical Analysis (if possible).

-Histopathological Studies.

7.4 Has the ethical clearance been obtained from your institution?

Yes.Enclosed

8. LIST OF REFERENCES

1.  Warrier PK, Nambiar VPK, Ramankutty C, editors. Indian Medicinal Plant. 1st ed. Chennai: Orient Longman Private Ltd; 1995.Vol III. p.316.

2.  Shastry JLN. Dravyaguna Vijananam. 2nd ed. Varanasi: Chaukhambha Orientalia; 2005.Vol II. p.434

3.  Pandey G. Dravya GunaVijanan. 2nd ed. Varanasi: Krishnadas Academy; 2002.Vol I. p.610.

4.  Bhardwaj Akhil, Khatri P, Soni ML, Ali DJ. Potent herbal hepatoprotective drugs-A review. Journal of Advanced Scientific Research.Updated 2011 [ cited 2012 Mar 19]; 2(2): 15-20.

5.  Chaudhary GD, Kamboj P, Singh I, Kalia AN. Herbs as liver savers-A review. Indian Journal Of Natural Products and Resoursces.Updated 2010 dec[cited 2012 Mar 19]; 1(4):397-408.

6.  Warrier PK, Nambiar VPK, Ramankutty C, editors. Indian Medicinal Plant. 1st ed. Chennai: Orient Longman Private Ltd; 1995.Vol III. p. 316.

7.  Pandey GS, editor. Bhavaprakasa Nighantu of Sri BhavaMisra. 10th ed. Varanasi: Choukhamba Barati Academy; 1995. p.463.

8.  Sharma PV, Sharma GP, editors. Kaiyadeva Nighantu of Kaiyadeva. 1st ed. Varanasi: Chaukhambha Orientalia; 1979. p.123.

9.  Tripati I, editor. Raja Nigantu of Narahari Pandit. 1st ed. Varanasi: Chowkhamba Krishnadas Academy; 1982. p.132.

10.  Sharma PV. Priya Nigantu. 2nd ed. Varanasi: Chowkhamba Surbharati Prakashan; 1995. p.111.

11.  Patiala R, editor. Madanapala Nigantu of Manadapala. 1st ed. Mumbai: Khemraj Shrikrishnadas; 1990. p.52.

12.  Pandey GS, editor. Bhavaprakasa Nighantu of Sri BhavaMisra. 10th ed. Varanasi: Choukhamba Barati Academy ; 1995. p.463.

13.  Sharma PV, Sharma GP, editors. Kaiyadeva Nighantu of Kaiyadeva. 1st ed. Varanasi: Chaukhambha Orientalia; 1979. p.123.

14.  Shastry JLN. Dravyaguna Vijananam. 2nd ed. Varanasi: Chaukhambha Orientalia; 2005. Vol II. p.434.

15.  BhardwajAkhil, Khatri P, Soni ML, Ali DJ. Potent herbal hepatoprotective drugs-A review. Journal of Advanced Scientific Research.Updated 2011 [cited 2012 Mar 19]; 2(2):15-20.

16.  Chaudhary GD, Kamboj P, Singh I, Kalia AN. Herbs as liver savers-A review. Indian Journal Of Natural Products and Resoursces. Updated 2010 dec [cited 2012 Mar 19]; 1(4):397-408.

17.  Medicinenet, inc. liver disease symptoms. (Online). 1995 October 18. [Cited 2012 February22];Availablefrom:http://www.medicinenet.com/liver_disease/page3.htm#symptoms.

18.  Ranade S, Ranade (mrs) Sunanda. Kayachikitsa. 1st ed. Delhi: Chaukhamba Sanskrit pratishthan; 2001.vol II. p.288.

19.  Sharma R, Dash B, editor. Charaka Samhitha of Agnivesha. 3rd ed. Varanasi: Chowkhambha Sanskrit Series office; 2002. Vol IV.p. 91.

20.  Baghel MS. Researches in Ayurveda. 1st ed. Jamnagar: Mridu Ayurvedic Publication & Sales; 1997. p. 130

21.  Baghel MS. Researches in Ayurveda. 2nd ed. Jamnagar: Mridu Ayurvedic Publication & Sales; 2005. p. 143.

22.  Baghel MS. Researches in Ayurveda. 2nd ed. Jamnagar: Mridu Ayurvedic Publication & Sales; 2005. p. 213.

23.  RGUHS. (Online). 2004 march 31[cited 2012 February 18]; Available from: http://www.rguhs.ac.in/

24.  Shastry PP, editor. Sharangadhara Samhitha of Sarangadhara with Deepika Commentary Madhyama Khanda. 5th ed. Varanasi: Chowkhamba Orientalia; 2002. p.178.

25.  Paget GE, Barnes JM. Evaluation of drug activities, pharmacometrics, Lawrance DR, Bacharach AL, editors. New York: Academic press; 1964. Vol I.p. 161.

9. Signature of the Candidate:

10. Remarks of Guide :

11. Name and Designation of :

(IN BLOCK LETTERS)

11.1 Guide : Dr. PRADEEP MD (Ayu),

LECTURER

Dept. of P.G. Studies in Dravyaguna

S.D.M.C.A, HASSAN

11.2 signature :

11.3 Co-Guide :Dr. RAVISHANKAR,

M.Sc.Ph.D(Pharmacology)

S.D.M Centre for Research in Ayurveda and

Allied Sciences, Udupi.

Remarks :

11.4 Signature :

11.5 Head of the Departmen: Dr. PRAKASH L.HEGDE

MD (Ayu), Ph.D. (Ayu)

Reader and HOD

Dept. of P.G. Studies in Dravyaguna

S.D.M.C.A, HASSAN

Remarks :

11.6 Signature :

12.1 Remarks of the

Chairman and Principal :

12.2 Principal : DR. PRASANNA N. RAO

M.S. (AYU), IMS, BHU, PhD

S.D.M.COLLEGE OF AYURVEDA AND

HOSPITAL, HASSAN – 573 201

12.3 SIGNATURE :