Completed Proforma for Registration of Subject for Dissertation

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,BANGALORE, KARNATAKA

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

A PHARMACOTHERAPEUTIC AND PHYTOCHEMICAL EVALUATION OF CHATURBEEJA CHURNA AS A COMBINATION & IN COMPARISON TO INDIVIDUAL EFFECTS OF KALAJAJIYAVANIBEEJA CHURNA W.S.R TO KASTARTAVA (PRIMARY DYSMENORRHEA).

dr.MANJULA. P.S, B.A.M.S.

POST GRADUATE DEPARTMENT OF DRAVYAGUNA,

A. L.N. RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE

AND P.G. CENTRE, KOPPA-577126

GUIDE:

DR. M. VIDYASAGAR, M.D (Ay)

PROFESSOR, P.G. DEPARTMENT OF DRAVYAGUNA

CO- GUIDE:

DR.SUSHRUTHA.C.K., M.D(Ay)

LECTURER, P.G DEPARTMENT OF DRAVYAGUNA

A. L. N. RAO MEMORIAL AYURVEDIC MEDICAL COLLEGEAND P.G. CENTRE,

KOPPA, KARNATAKA – 577126

2010-2011

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FORDISSERTATION

1. NAME OF THE CANDIDATE & : Dr. MANJULA .P.S

ADDRESS (In block letters) W/O DR.K.M.SIDDALINGAMURTHY

A.L.N.RAO MEMORIAL AYURVEDIC

MEDICAL COLLEGE AND P.G CENTRE

COLLEGE QUARTERS NO7.

2. NAME OF THE INSTITUTION : A.L.N.RAO MEMORIAL AYURVEDIC

MEDICAL COLLEGE AND P.G CENTRE

KOPPA 577126

CHIKMAGALUR (DIST)

KARNATAKA.

3. COURSE OF STUDY & SUBJECT : AYURVEDA VACHASPATHI

MD (AY) IN DRAVYA GUNA

4. DATE OF ADMISSION OF COURSE : 25/08/2010.

5. TITLE OF THE TOPIC : A PHARMACOTHERAPEUTIC

& PHYTOCHEMICAL EVALUATION OF

CHATURBEEJA CHURNA AS A

COMBINATION & IN COMPARISON TO

INDIVIDUAL EFFECTS OF KALAJAJI

& YAVANIBEEJA CHURNA W.S.R TO

KASTARTAVA (PRIMARY

DYSMENORRHEA).

6. Brief resume of the intended work:

6.1Need for the study:

Ayurveda consider health as a pre-requisite for leading a happy life. In our classics vedhana has been mentioned two types, sukhatmakadukhatmaka. Dukhatmakavedhana is referred to pain afflicting to both body & mind1. Among many Dukhatmakavedhana the one is Kastartava which makes to suffer a lot for women’s & adolescent girls.

Kastartava is broad term which covers all the problems & ailments that a woman may suffer from pain during menstruation. It is a condition mentioned in various artavavyapat & other diseases related with female reproductive system. By analysis one can state this is a result of vatavrudhi, apanavatamargavarodha, and artavadushtidhatukshaya. Kastartava can be compared with the Dysmenorrhea in Modern medicine2, 3,4,11.

Dysmenorrhea is one of the most common gynecological complaints in young women who present to clinician’s with c/o pain during menstruation that interferes with daily activities17. Although it is not life threatening, Dysmenorrhea can be debilitating & psychologically taxing for many working women’s & school going adolescents leading to significant absenteeism. Its prevalence is estimated at 25% of women &up to 90% of adolescents. The majority of cases of Dysmenorrhea are Primary Dysmenorrhea. In the present study Kastartava is taken for Primary dysmenorrhea.

Globally people are presently diverting towards plant based medicines which are comparatively safe & effective than the synthetic preparations.

As mentioned in our classics that each individual drugs in Chaturbeejaviz, Methika(Trigonellafoenum-graecumLinn.), Chandrasura(LepidiumsativumLinn.), Kalajaji(Nigella sativaLinn.)Yavani(Trachyspermum ammi (Linn.) Sprague.) shows specific actions like Garbhasaya shodhaka, vatahara, shoolaghna, vatanulomana, dhatuposhaka etc, which helps to infer their effective treatment in Kastartava (PrimaryDysmenorrhea)5,6,7,8,9,13,14.

So a comparative clinical study is undertaken with Chaturbeeja churna, Kalajaji churna, and Yavani churna to evaluate its safety and efficacy on Kastartava (Primary dysmenorrhea).

6.2. Review of literature:

A. Drug review:5, 6, 7,

It includes screening of all classical Ayurvedic literature like Bhavaprakasha nighantu, Dhanvantari nighantu etc & also Ethno botanical as well as related books on allied sciences to compile sufficient literary data for the study on action of trial drugs on Primary dysmenorrhea.

B.Disease review:2,3,4,11

Kastartava is a symptom found in various Yoni Vyapats& other diseases related to female reproductive organs, which will be studied in detail. The modern aspect of Dysmenorrhea will be well studied.

Following books will be reviewed:

Charaka Samhita1,2.
Sushruta Samhita3.
Astanga Hrudaya4.
Bhavaprakasha Nighantu5.
Nighantu Adarsha7.
Indian Materia Medica13.
Indian Medicinal plants14.
DravyaGuna Vigyana18.

6.3 Objectives of study

To evaluate action of Chaturbeeja churna in Primary dysmenorrhea.
To evaluate action ofYavanichurna inPrimary dysmenorrhea.
To evaluate action ofKalajajichurna in Primary dysmenorrhea.
To evaluate & establish the comparative effect between 3 groups inPrimary dysmenorrhea.
To carryout Pharmacognostical & Phytochemical evaluation of drugs.

7.Materials & Methods

7.1Source of data

Source can be Literary source, Analytical source & Clinical source.

a.Literary source:

Literary data can be obtained from the classics &from the contemporary books.

b.Analytical source:

Include Phytochemical studies & Pharmacognostical evaluation.

c.Clinical source:

Female patients diagnosed as having Kastartava, from IPD& OPD at ALN Rao Memorial Ayurvedic Medical College & Hospital, Koppa& other associated Hospitals will be selected for the study.It is a randomized single blind clinical study with a pre-test & post-test design where in Chaturbeejachurna, Yavanibeejachurna, &Kalajajibeejachurna are the trial drugs.

7.2 Methods of collection of data (Including sampling procedures)

Female Patients of the age group 15 to 30 yrs diagnosed as Primary dysmenorrhea/Kastartava based on clinical signs & symptoms are selected from In-patient & Out-patient department of ALN RAO AMC & Hospital,Koppa & associated hospitals.

Sample Size:

It is a clinical study with pre-test & post-test design where 60 patients diagnosed as

suffering from Kastartava will be selected.

Groups:

There will be three groups consisting of each 20 patients.

Duration of treatment:

The duration of treatment will be for 15days. Starting from 5 days before expected date of menstrual cycle &continued for10 days during menstruation for 3 menstrual cycles. Follow up for next menstrual cycle. A special format will be prepared with all points of history taking, physical examination etc as mentioned in our science & allied sciences. Patients will be examined & selected accordingly. The parameters of signs & symptoms will be on the basis of appropriate ‘f’ test & student’ t’test.

Parameters:

Inclusion criteria:

Patients within the age group 15 to 30 yrs

Patients sufferingfrom painful menstruation.

Exclusion criteria:

If congenital anomalies is cause for Dysmenorrhea. Any pelvic pathology, acute infection, acyclic & excessive bleeding for more than 5days, Endometriosis, Adenomyosis, Uterine fibroid endometrial polyp, PCOD& other medical, surgical, Neurological conditions resulting in Dysmenorrhea. Patients of Known case of Diabetes mellitus & Hypertension.

Assessment criteria:

The patient’s response will be assessed on the basis of subjective parameters. Pain will be assessed using clinical grading starting from 0(zero) to 3(three).

Scoring pattern of symptoms:

0-Menstruation is not painful & daily activities unaffected.

1- Menstruation is painful & daily activities unaffected, No analgesics needed.

2- Menstruation is painful & daily activities affected & analgesics needed.

3-Menstruation is painful & unable to perform daily activities & absent for work/classes, analgesics shows poor effect.

Associated symptoms:

1) Atisara

2) Vibhanda

3) Praseka

4) Chardi

5) Bhrama etc

These associated symptoms are observed during the pre-test and post-test of the study.

Final assessment of treatment:

Percentage of relief effects

1. Cured- relief for 100%

2. Marked improvement-relief from 75-100%

3. Moderate improvement- relief from 50-75%

4. Mild improvement –relief from 25-50%

5. No relief – below 25%

Intervention:

The selected patients will be administered.

Sl. no / Traits / Group A / Group B / Group C
1 / Sample size / 20 / 20 / 20
2 / Medicine / Chaturbeejachurna / Yavanibeejachurna / Kalajajibeejachurna
3 / Dose15 / 6gms BD / 6gms BD / 6gms BD
4 / Anupana / Lukewarm water / Lukewarm water / Lukewarm water
5 / Duration / 5days before expected date & continued for 10 days for 3 months / 5days before expected date &continued for 10 days for 3 months / 5days before expected date &continued for 10 days for 3 months
6 / Follow up / Next menstrual cycle / Nextmenstrual cycle / Nextmenstrual cycle

7.3 Does the study require any investigation or intervention to be conducted on the patients or other humans or animals? If so please describe briefly:

Yes, the study will be conducted on human subjects who match inclusion criteria.

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

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

8. References:

1.Acharya Agnivesha Caraka Samhitha shareera stana1 chapter with introduction by Sri Satya NarayanaSastri published by Chaukhambha Bharati Academy Varanasi Reprint 1998,page :823.

2. AcharyaAgnivesha Caraka Samhitha ChakrapaniKrutha Ayurveda DipikaVyakhyaChikitsa stana-30 edited by Dr.G.S. Pandey forward by Vaidya YadavjiTikamjiAcharya, published by Chaukhambha Sanskrit Sansthan Varanasi Reprint edition 2006.page:752,754.

3.Acharya Sushruta, Sushruta Samhitha edited with Ayurveda-tattvaSandipikaUttara tantra-38 by KavirajaAmbikaDuttaSastri,published by Chaukhambha Sanskrit Sansthan Reprint edition 2004.page:156.

4.Aharya Vagbhat Astanga Hrudayam, ArunDutta KrutaSarvangaSundariHemadri Kruta Ayurveda RasayanaVyakhyaUttara stana-33, published by Krishnadas Academy Varanasi Reprint.page:897.

5. Bhava PrakashaNighantu of Sri Bhava Mishra commentary by Dr.K.C.Chunekar edited by Dr.G.S.Pandey published Chaukhambha Bharati Academy Varanasi Reprint 1999.page:25,32,33,38,39.

6. Raja Nighantu by Dr.IndradevaTripathi published by ChaukhambhaKrishnadas Academy Varanasi 4thediton 2006.page:147,148,141.

7. Nighantu Adarsha by Bapalal.G.VaidyaPurvardha published by Chaukhambha Bharati Academy Varanasi Reprint year 2007.page:21,74,411,669,679.

8. DhanvantriNighantu edited by Prof PriyaVrat Sharma published by ChaukhambhaOrientalia Varanasi 4nd Edition 2005.page:80,82,86,167.

9. KaiyadevaNighantu edited by Prof PriyaVrat Sharma published by ChaukhambhaOrientalia Varanasi 2nd Edition 2006.page:222,219.

10.Shaligrama Nighantu, BhushanBruhatNighanturatnakarantargata 7-8th part published by ShriKrishnadasPrakashana Bombay 4.

11. AyurvediyaPrasutitantraEvamStriroga part -2 Striroga by Prof PremavatiTewari published by ChaukhambhaOrientalia Varanasi 2nd Edition 2000 page 150, 244.

12.Text Book of Gynaecology by Prof D.C.Dutta (ed) HiralalKonar published by New Central Book agency (p) Ltd Calcutta 4th edition 2003 page 168-174.

13. Dr.K.M.Nadakarni’s Indian MateriaMedicapublished by Popular Prakashan Bombay 1976 vol 1-page 280, 408, 736, 854 & 1240.

14. Krithikar.K.RBasu.B.D,Indian Medicinal Plants, published by International book distributors vol-1 page 174, 700-701,Vol 2:Page:1201,1204.

15. C.P.Khare, Indian Medicinal Plants, An Illustrated Dictionary copy write 2007 springer science ,second Indian reprint 2008, page no;489-440.

16. Warrier.P.K –Indian Medicinal Plants –A Compendium of 500 species V.P.K. Nambiar, Orient Longman (pvt) Ltd Chennai 1995 Reprint 2006 vol- 4 page 139, vol-3 page313

17. Ayurvedic pharmacology & Therapeutic Uses of Medicinal Plants(DravyaGunaVignyana) by Vaidhya Vishnu MahadevGogte published by Chaukhambha publications New Dehliediton Reprint 2009 page 353, 468, 551, 606, & 700.

18. P.V.Sharma ,Dravyagunavigyana ,vol 2,Chaukhambha BharatiAcademy Varanasi Reprint year 2003, page:368,494,498,596,823.

9. Signature of the candidate :

10. Remarks of the guide :

11. Names and Designation of

(In Block letters)

11.1. Guide : Prof.M. Vidyasagar, M.D (Ayu) (Pbi.u)

Professor and HOD,

P.G Department of Dravya guna,

A.L.N.Rao Memorial Ayurvedic MEDICAL

College, Koppa-577126,

Chikmagalur Dist, Karnataka.

11.2. Signature :

11.3. Co-guide : DR.SUSHRUTHA.C.K. M.D (Ayu)

LECTURER

P.G Department of Dravya guna,

A.L.N.Rao Memorial Ayurvedic MEDICAL

College, Koppa-577126, Chikmagalur Dist,

Karnataka

11.4. Signature:

11.5. Head of Department :Prof. M. Vidyasagar, M.D (Ayu) (Pbi.u)

Professor and HOD,

P.G Department of Dravyaguna,

A.L.N.Rao Memorial ayurvedic

mEDICAL College, Koppa-577126,

Chikmagalur Dist, Karnataka.

11.6. Signature :

12.1. Remarks of Principal :

12.2. Signature :