Rajiv Gandhi University of Health Sciences s43

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

“PHARMACOGNOSTICAL AND THERAPEUTICAL EVALUATION OF SWIETENIA MAHAGONI JACQ. SEEDS AND JAMBU-SYZYGIUM CUMINI (LINN) SKEELS. SEEDS IN MADHUMEHA W.S.R. TO DIABETES MELLITUS- A COMPARATIVE STUDY”

DR. DIVYA KHARE B.A.M.S

POST GRADUATE DEPARTMENT OF DRAVYA GUNA

A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE

AND P.G. CENTRE, KOPPA – 577126

GUIDE :

DR. H. R. PRADEEPM.D.(Ay.)

PROFFESSOR, PG DEPARTMENT OF DRAVYAGUNA

A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE

AND P.G. CENTRE, KOPPA, KARNATAKA – 577126

2009 - 2010

A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE

AND P.G. CENTRE, KOPPA, KARNATAKA – 577126

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR REGISTRATION

1. Name of the candidate and address : DR. DIVYA KHARE

D/O LATE SRI. R.S.KHARE

”KALARAVA” , MIG-6 (TYPE-I),

KHB COLONY , GANDHI NAGAR,

SAGAR – 577401 , SHIVAMOGGA DIST.

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

MEDICAL COLLEGE AND P.G.CENTRE,

KOPPA – 577126 , CHIKMAGALUR DIST.

3. Course of study and subject : Ayurveda Vachaspathi / M.D.(Ayurveda)

In Dravya Guna

4. Date of admission to the course : 23th November 2009

5. Title of the Topic : “PHARMACOGNOSTICAL AND

THERAPEUTICAL EVALUATION OF

SWIETENIA MAHAGONI JACQ. SEEDS

AND JAMBU [SYZYGIUM CUMINI

(LINN) SKEELS.] SEEDS IN MADHUMEHA

W.S.R. TO DIABETES MELLITUS -

A COMPARATIVE STUDY”

6. Brief resume of the intended work

6.1 Need for the study

As truly said in our classics,

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The trend of urbanization and modern lifestyle, most importantly a high calorie diet and sedentary habits have increased the risk of Madhumeha2 vis a vis Diabetes mellitus. The disease cannot be cured completely2 i.e. the patients have to bear with it throughout their life. So, the treatment modality in this case aims at preventing or delaying the complications and maintaining the health3 by means of dietary changes, exercise and medication.

Diabetes is a burning problem of the day, afflicting people from various walks of life. As per the present statistics, India ranks second in Diabetic population, next only to China4. At present approximately 40.9 million people suffer from Diabetes and this number is likely to increase to 69.9 million by the year 2025, and it is being predicted that India will become the Capital of Diabetes by 2025. Type 2 Diabetes is more common form constituting 95% of the Diabetic population5.Globally and Nationally Diabetes mellitus has become the most important contemporary and challenging health problem.

Our classics have described the uses of plants based on their therapeutic actions. In Charaka Samhita, in the context of Panchashanmahakashaya varga, we find the mentioning of Mutrasangrahaniya and Mutravirajaniya karma6, which are particularly useful in the disease madhumeha.

Nowadays medicinal plants are being looked up once again for the treatment of Diabetes. This is mostly because of their supposedly less frequent side effects.

Swietenia mahagoni Jacq. is a tropical American plant introduced to India as an avenue tree, now being recognized by the folk for its medicinal properties. The powdered seeds in empty stomach are successfully employed for the treatment of Diabetes in east Midnapore (West Bengal), Southern parts of Karnataka and many parts of Kerala7. Most of the herbal drugs indicated for Madhumeha in our classics are having tikta rasa. The tikta rasa has kleda and medo vishoshana property8, which is needed in Madhumeha. The seed of Swietenia mahagoni Jacq. is predominantly having bitter taste.

On the other hand Jambu [Syzygium cumini (Linn) Skeels.] seed is mentioned as madhumehahara9 in our classics. It has kashaya rasa predominantly, which is known for its kleda, meda shoshana action10. Kernel of Syzygium cumini (Linn) Skeels. is used as household remedy for diabetes. This also forms a major constituent of many herbal formulations for diabetes and is proved for its hypoglycemic activity. So, with this background, an attempt is being made to investigate and compare the antidiabetic activity of Swietenia mahagoni Jacq. seeds and Syzygium cumini (Linn) Skeels. seeds, clinically.

6.2 Review of literature

In order to prove the above hypothesis, proper screening of classical literature, contemporary texts, previous works, research articles, internet, journals and periodicals will be done so as to get sufficient background information to carry out the study.

Review of literature will be dealt under two headings.

I. Drug review

Seeds of medicinal plants are common ingredients of many folk and herbal medicines. Swietenia mahagoni Jacq. (Meliaceae) is a large evergreen tree of immense oriental value. It is not mentioned in any of our classics. The seeds have been used as a folk medicine for the treatment of Hypertension, Diabetes and Malaria11,12. Since the drug is not mentioned in classics, information regarding its properties , mode of action and the therapeutic values will be obtained from ethnobotanical books, journals, articles, others contemporary texts and internet.

Regarding the drug Jambu [Syzygium cumini (Linn) Skeels.], information will be collected from the classical texts, other contemporary books and ethnobotanical books.

II . Disease review

A thorough screening of the classical Ayurvedic texts like Brihatrayee, Laghutrayee etc. wherein references regarding the disease Madhumeha are available will be reviewed and recorded. Previous works, journals, articles etc. will also be referred for relevant information.

Some of the books are listed below,

1. Charaka samhita – nidana sthana 4th chapter and chikitsa sthana 6th chapter

2. Sushruta samhita – nidana sthana 6th chapter and chikitsa sthana 11th and 13th chapter

3. Ashtanga hridaya – nidana sthana 10th chapter and chikitsa sthana 12th chapter

4. Madhava Nidana – Chapter 33

5. Sharangadhara, Madhyama Khanda – Chapter 11

6. Yogaratnakara – uttarardha

7. Davidson’s Principles and Practice of Medicine

8. Harrison’s Principles of Internal Medicine

9. API Text book of Medicine

7.Objectives of the study

A. To evaluate and compare the hypoglycemic activity of Swietenia mahagoni seeds and Syzygium cumini (Linn) Skeels. seeds, clinically.

B. To carry out the pharmacognostical and phytochemical analysis of the trial drugs.

C. To introduce new valuable drug to the Ayurvedic Pharmacopoea based on the concept of anukta dravya.

8.Materials and methods

8.1 Source of data

The source of data can be literary source, clinical source and analytical source.

A. Literary source – Literary data can be obtained from the classical texts, internet and from the contemporary books.

B. Analytical source – Analytical data include phytochemical studies and pharmacognostical evaluation.

C. Clinical source – Patients of either sex diagnosed as having Madhumeha , from IPD and OPD at A.L.N.Rao Memorial Ayurvedic Medical College and Hospital , Koppa and other associated hospitals will be selected for the study. It is a non- randomized single blind study with a pretest and post test design wherein Swietenia mahagoni Jacq. seed and Syzygium cumini (Linn) Skeels. seed are the trial drugs.

8.2 Methods of collection of data ( Including Sampling Procedure )

Patients of either sex, of the age group of 30 to 70 years, diagnosed as having Madhumeha based on the classical signs and symptoms will be selected for study from the IPD and OPD at ALNRMAMC Hospital, Koppa and associated hospitals.

The general condition of the patient is assessed by systemic examinations and are selected for the study, if found fulfilling the inclusion criteria.

A.Subjective Parameters13

· Prabhuta mutrata

· Aavila mutrata

· Pipaasa

· Sada and Tandra

B.Objective Parameters

· Complete urine examination

· FBS

· PPBS

The subjective parameters will be assessed by means of interrogation and by ascertaining the signs and symptoms before and after treatment. The objective parameters will be assessed through the laboratory investigations before and after treatment.

The results of laboratory investigations such as FBS, PPBS and urine examination are documented properly along with other presenting complaints of the patients before the treatment is started. The improvement observed will be documented properly in a specially designed case proforma.

*Sample size – It is a clinical study with pretest and post test design, where in 40 patients of Madhumeha will be selected. They will be divided into two groups, each group consisting of 20 patients.

*Duration of treatment – The total duration of treatment is 60 days. The response of the patient to the medicine is assessed at regular intervals of 30 days, through interrogation and through improvements in subjective and objective parameters.

The results thus obtained will be tabulated and appropriate student ‘t’ test will be employed to assess the significance of the result.

PARAMETERS

A.Inclusion Criteria

1. Patients presenting with pratyatma lakshana of Madhumeha like prabhuta mutrata , aavila mutrata, pipaasa, saada and tandra.

2. Patients of either sex within the age group of 30 to 70 years.

3. Newly diagnosed patients of Type 2 Diabetes mellitus, having FBS ranging from >126 mg/dl to 180 mg/dl and PPBS ranging from >160 mg/dl to 250 mg/dl.

4. Established and treated cases of Type 2 Diabetes mellitus without any complications, who voluntarily adopted the Ayurvedic line of treatment.

B. Exclusion Criteria

1. Age below 30 years and above 70 years.

2. FBS level more than 180 mg/dl, PPBS level more than 250 mg/dl.

3. Sahaja or Jataja Madhumeha w.s.r.to Genetic Syndromes and Juvenile Diabetes.

4. Patients with any systemic illness, pregnancy, lactating mothers.

5. Patients with Diabetic gangrene, carbuncles and other complications of Diabetes.

8.3 Treatment Schedule

The total number of patients selected for the study is 40. They will be divided into two groups, with 20 patients in each group. One group will be administered powdered seeds of Swietenia mahagoni Jacq. and the other will be given powdered seeds of Syzygium cumini (Linn) Skeels. Along with that, suitable diet and exercises will be advised to the patient.

Dosage:

· Group A - Based on the folklore reference, 1 gm of powdered seeds of Swietenia mahagony Jacq. will be given per day in divided doses in the form of capsules.

· Group B – Powdered seeds of Syzygium cumini (Linn) Skeels., 2gm per day14 in divided doses.

Duration of treatment

· The total duration of treatment will be 60 days.

Group A / Group B
Number of samples / 20 / 20
Drug Intervention / Powdered seeds of Swietenia mahagoni Jacq. / Powdered fruits of Syzygium cumini (Linn) Skeels.
Dosage / 1 gm per day in divided doses for an average person weighing 60kg / 1 gm per day in divided doses for an average person weighing 60kg
Form of administration / 500 mg Capsules, 1 bid / 500 mg capsules, 1 bid
Time of administration / After food / After food
Anupanam / Water / Water
Duration / 60 days / 60 days

9. Final assessment

The results will be assessed based on the improvement in subjective and objective parameters.

a) Reduction in symptoms

b) Reduction in blood glucose and urine sugar

10. Does the study require any investigations or interventions to be conducted on patients or other human or animal? If so please describe briefly.

Yes, the study will be conducted on human subjects suffering from Madhumeha – Diabetes mellitus.
Investigations – The following investigations will be undertaken during the study.

Complete urine examination

Blood – FBS

PPBS

C. Intervention: –

11. Has ethical clearance been obtained from your institution in case of (10.)?

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

12.REFERENCES

Acharya Agnivesha, Charaka Samhita. Elaborated by Charaka and Drudhabala with Ayurveda Dipika commentary By Chakrapani Dutta. Edited by Yadavji Trikamji Acharya, Varanasi, Chaukhamba Sanskrit Samathana, 2002, Nidana Sthana – 4th Chapter – shloka number 50.
Acharya Agnivesha, Charaka Samhita. Elaborated by Charaka and Drudhabala with Ayurveda Dipika commentary By Chakrapani Dutta. Edited by Yadavji Trikamji Acharya, Varanasi, Chaukhamba Sanskrit Samathana, 2002, Nidana Sthana – 4th Chapter – shloka number 44.
Acharya Sushrutha, Sushrutha Samhita, Elaborated by Kaviraj Dr.Ambikatanayadatta Shastri with Ayurveda Tatvasandipika Hindi commentary, 1st volume, Chikitsa Sthana – 11th Chapter, Shloka no. 6
Times of India – 30/03/2010
Hindustan Times – Thursday, 1st April
Acharya Agnivesha, Charaka Samhita. Elaborated by Charaka and Drudhabala with Ayurveda Dipika commentary By Chakrapani Dutta. Edited by Dr. Bhagwan Dash, Varanasi, Chaukhamba Sanskrit Samathana, 2004, Sutra Sthana – 4th Chapter – shloka number 15, page no.96
http://www.greenpharmacy.info/text.asp?2008/2/4/224/44738
Acharya Vagbhata, Astanga Hridaya, with Arunadataa’s Sarvangasundara and Hemadri’s Ayurveda Rasayana commentary, Edited by Pt. Krishnashastry, Chaukhamba Sanskrit Pratishthana, Edition 2009,Sutrasthana, Chapter10, shloka no.14, page 176
Prof.P.V.Sharma, Dravyaguna Vijnana, 2nd Volume, Chaukhamba Bharathi Academy, Edition 2001, page 661
Acharya Vagbhata, Astanga Hridaya, with Arunadataa’s Sarvangasundara and Hemadri’s Ayurveda Rasayana commentary, Edited by Pt. Krishnashastry, Chaukhamba Sanskrit Pratishthana, Edition 2009,Sutrasthana, Chapter10, shloka no.20, page 176
http://www.eurojournals.com/ejsr.htm , In Vitro Cytotoxic Properties of Ethanolic Extracts of VariousParts of Swietenia Mahagoni, LiDD et al., 2005

12. www.mdpi.com/journal/molecules Nagalakshmi, M.A.H.; Thangadurai, D.; Muralidara, D.; Pullaiah, R.T. Phytochemical and antimicrobial study of Chukrasia tabularis leaves. Fitoterapia 2001, 72, 62–64.

Acharya Sushrutha, Sushrutha Samhita, Elaborated by Kaviraj Dr.Ambikatanayadatta Shastri with Ayurveda Tatvasandipika Hindi commentary, 1st volume, Nidana Sthana – 6th Chapter, Shloka number 5.
Acharya Bhavamishra, Bhavaprakasha Nighantu, by Dr. Krishnachandra Chunekar, Chaukhamba Publications, 2009, Amradi Phala Varga, page number 570.

13. Signature of the candidate :