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6. brief resume of intended work 1 Need for the study


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6. BRIEF RESUME OF INTENDED WORK
6. 1 Need for the study:

Diabetes is worldwide in distribution and the incidents of both type I and type II diabetes is rising. It is estimated that in year 2000, 171million people worldwide had diabetes, and this is expected to double by 20301 .It is calculated that approximately 50.8 million adults with diabetes in India. India will be the “diabetes capital” of the world, by the end of 20302. Diabetes mellitus can be classified as insulin dependent or type – I or IDDM, non-insulin dependent or type – II or NIDDM. NIDDM commonly has its onset in age group 45 – 65 yrs. Although it may affect relatively younger population in India & other developing countries3. NIDDM can be usually controlled with diet exercise & oral hypoglycemic agents (OHA) for a quite good number of years. Up to 50% patients of NIDDM initially treated with OHA ultimately need insulin 4.

Although a number of our preparations are currently available, it is clear that no drug is ideal for the treatment of majority of NIDDM patients. Thus development of new and noval therapeutic approaches remains highly desirable. Several herbs are described in Ayurvedic literature for the management of madhumeha one amoung them is “Kataka”. In present study an attempt will be made to evaluate the efficacy of “Kataka phala” (Strychnous potatorum Linn.) in the management of Madhumeha(NIDDM) w.s.r to Anti hyperglycemic activity , with a view to find out a therapeutically efficacious , safer , cost effective , easily available , & effective even on the long run .
6.2. Review of literature

Kataka” (Strychnos potatorum Linn.) belonging to family “Loganiaceae”, Distributed throughout widely in Konkon, N.Kanara, Central India, South India and Burma. It is moderate sized glabrous tree of family Loganiaceae growing up to 12 meters in height5.

It is having properties like madura tikta kashaya rasa, lughu visada guna, sita virya, madhura vipaka, vata-Kapha Samaka and Karma- Madhumehahara, yakrut vikaras, swethapradara. Amlapitta, atisaara, Akshi vikaras. 6

All the ancient treatises give detailed description of the disease ‘Prameha’ and Chikitsa also. “Madhumeha” is a variety of vatajaprameha, in which the patient micturates urine similar to panduvarna, madhura, kashaya rasa, and ruksha guna7.



In classics, lakshanas of madhumeha is confined only to mootra and mootrapravrutti like prabhuta, avila mootra. Vishesha lakshanas as, madhura, kashaya, ruksha, pandu but sushrutha also explained sarva daihika lakshanas of madhumeha in the context of sahaja and apathya nimittaja prameha. Sahaja prameha lakshanas are krusha, ruksha, alpaashi, paribhramana sheela and apathya nimittaja lakshanasa are sthula, snigdha, bahuashi, swapnasheelatha 8. All the bruhathrayees and laghuthrayees of Ayurveda have mentioned about madhumeha 9,10,11,12. All types of prameha if left untreated they ultimately lead to madhumeha. In which person passes urine which resembles honey13a, b. Madhumeha appears to have strong correlation and similarities to Diabetes mellitus.

Diabetes mellitus is a clinical syndrome characterized by hyperglycemia due to absolute or relative deficiency of insulin. This high blood sugar produces the classical symptoms of polyuria (frequent micturation), polydipsia (increased thirst) and polyphagia (increased hunger). 14

6.3. Aims and objectives of the study:

  • To evaluate the Pharmacognostic and phytochemical study of Kataka phala.

  • To evaluate the clinical efficacy of kataka phala in the management of Madhumeha w.s.r Anti hyperglycemic activity.

6.4. Previous work done:

  • Effect of Kataka (Strychnos potatorum Linn.) on urinary disorders. Narasimha.V, IMS, Faculty of ayurveda, BHU, Varanasi (UP) 2004 15a.

  • Role of kataka(Strychnos potatorum Linn.) In the management of dry eye wsr to Pothaki (trachoma). Srivastava A.K, IMS, Faculty of ayurveda, BHU, Varanasi (UP). 200115b.

  • Effect of Kataka beeja on water borne infections organised in vitro study, Prasad Navaneet ,RGUHS, Banglore.198915c

  • Antidiabetic effect of seeds of Strychnos potatorum Linn. In STZ model of diabetes. Asish biswas 16




  • Evaluation of anti-diabetic activity of Strychonous potatorum in alloxan induced diabetic rats. Dhasarathan P and Theriappan P Department of Biotechnology, Prathyusha Institute of Technology and Management, Thiruvallur16.

7. Materials and methods:

7.1. SOURCE OF DATA:

  • Literary source: The literary aspect will be reviewed and data will be collected from classical Ayurvedic literatures, modern texts updated with recent medical journals, internet and other available sources.

  • Source of drug: Genuine, botanically identified Kataka phala will be collected from its natural habitat.

  • Sample source: Freshly diagnosed patients will be randomly selected from OPD and IPD of JSS Ayurveda Medical College and Hospital, Medical camps and referrals.




    1. METHOD OF COLLECTION OF DATA

a) Pharmacognostical and Phytochemical study

The drug will be identified botanically and collected authentically from the natural sources and will be taken for pharmcognostic and phytochemical studies.



b) For clinical study:

1. Study design:

  • Prospective comparative single blind clinical trial.

2. Sample size:

A minimum of sample 60 patients will be selected. Divided into two groups 30 patients will be treated in each group. Group A will receive kataka phala churna. Group B will receive standard drug Glybenclamide. Similar diet and exercise will be advised to both groups.



Method of administration:

6 gms of kataka phala churna will be given twice daily with jala as anupana.



3. Inclusion criteria:

  • Patients having clinical symptomatology of Madhumeha (NIDDM) with Specific bio chemical investigation will be done on patients with Fasting Blood Sugar level between 120 to 180 mg/dl and Post Prandial Blood Sugar level up160 to 280 mg/dl selected for the study

  • Patients between the age group of 35 to 65 years

  • Both male and female patients

4. Exclusion criteria:

  1. Patients less than 35 years and above 65 years of age.

  2. Insulin dependent DM.

  3. Known case of systemic disorders.

  4. Patients with other endocrine disorders.

  5. Patients with diabetic complications.

  6. Non diabetic glycosuria.

5. Diagnostic Criteria: Based on subjective and objective parameters of Madhumeha

6. Study Duration: Study will be carried out for 30days, will be reviewed once in 7 days with follow up of 10 days

7. Interventions: Duration of treatment – 30days

Group

No. Patients

Drugs

Dose/Day

Anupana

A (Stand. Group)

30

Glibenclamide

2.5mg/BID

Jala (Water)

B (Trial Group)

30

Kataka phala

6gm/BID

Jala (Water)

8. Assessment of result

Subjective and objective parameters are taken for assessment of result

Results will be analyzed statistically by using paired “t” test.

9.1. Subjective parameters


  • Mukha_talu_kantha sosha

  • Karapaada supta daaha

  • Shareera bharahani

  • Prabhutha mutratha

  • Aavila mootrata

9.2. Objective parameters

  • Blood for fasting Blood sugar

  • Blood for post prandial blood sugar

  • Urine for sugar

  • Body weight

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

Yes, the study will be conducted clinically; no animal experimentation will be carried out.



    1. .Has Ethical clearance been obtained from your institution in case of 10?

Yes,obtained certificate enclosed
11. LIST of references:

  1. Davidson’s, Davidson Principles & Practice of Medicine, Chapter 21 Brian R Walker Stuart H Ralston editor, 20th Edition, Edinburgh: Elsevier; 2006. P.808.

  2. http//www.indian express.com/news/india-has-largest-number-of-diabetes patient, 22nd April 2013.

  3. Sainani.G.S, API text book of medicine, Vol 1, Chapter 9th, Munjal YP editor.6th edition. Mumbai: Jaypee Brothers Medical publishers; 1999.P.988.

  4. Tripathi.K.D, Essentials of medical Pharmacology, Chapter 19th. 4th edition. New Delhi: Jaypee Brothers Medical publishers; 1999. P.276.

  5. Kiritikar.K.R & Basu.B.D, Indian Medicinal Plants, Vol 3. E.Blatter, J.F.Caius & K.S.Mhaskar editor. 2nd edition. Dehra -Dun: International book distributors; 2008. P.1647.

  6. Kaiyadeva, Kaiyadeva Nighantu, Oushadhi varga, Chapter 1, P.V.Sharma editor, 2nd edition, Varanasi, Chaukhambha Orientalia, 2006. P 211.

  7. Agnivesha, Charaka Samhita, Nidana Sthana, Chapter 4, Shloka 37th, Jayadeva Vidyalankar Editor, 9th Edition, Varanasi, Motilal Banarasdas, Reprint 1994.

  8. Sushruta, Sushruta Samhita, Nidana Sthana, Chapter 6th ,Shloka 6th , Jadavji Trikamji Acharya Editor, Varanasi, Chaukambha Sanskrit Samsthan, Reprint 2010,P 291,451.

  9. Vagbhata, Astanga Hrudaya, Vol 2 Nidana Sthana, Chapter 10th, Shloka 16, 2nd Edition, Varanasi, Krishnadas Academy, 1995, P95.

  10. Vaidya Lakshmipathi Shashtri, Yogaratnakara, Uttarardha, Shloka 15, Bhramha Shankar Shashtri Editor, Varanasi, Chaukambha Prakashan, Reprint 2009, P78.

  11. Agnivesha, CharakaSamhita, Chikitsa Sthana, Chapter 6, Shloka 10, 11, Jayadeva Vidyalankar Editor, 9th Edition, Varanasi, Motilal Banarasdas, Reprint 1994.

  12. Sushruta, Sushruta Samhita, Chikitsa Sthana, Chapter 11th, Shloka 12, Jadavji Trikamji Acharya Editor, Varanasi, Chaukambha Sanskrit Samsthan, Reprint 2010, P451.

  13. Vagbhata, Astanga Hrudaya, Nidana Sthana, Chapter 10, a)Shloka 17, b)Shloka 21, 2nd Edition, Varanasi, Krishnadas Academy, 1995, P95.

  14. Davison”s, Davidson Principles & Practice of Medicine, Chapter 20th, 21st Edition, Brain R Walker & Stuart Ralston Editor, Edinburg, Elsevier, 2006, P808.

  15. Bhagel M S, Researches in Ayurveda, 2nd Edition, Jamnagar, Mridu Ayurvedic publications, 2005.

  16. Journal of Medicine and Medical Sciences Vol. 2(2) pp. 670-674 January 2011 Available online@ http://www.interesjournals.org/JMMS




11.

Signature of the Candidate






12.

Remarks of the Guide



The dissertation topic chosen for research will certainly help the society and can contribute good values for research.

13.

Name and Designation of
13.1 Guide

13.2 Signature
13.4 Head of the Department


13.5 Signature




Dr.Kuber Sankh, M.D. (ayu)

Reader


Department of Post Graduate Studies in DravyagunaVignana,

JSS Ayurveda Medical College, Mysore.




Dr.Nagamani. M.D. (Ayu)

Professor and HOD

Department of Post Graduate Studies in DravyagunaVignana,

J.S.S Ayurveda Medical College, Mysore.





14.

14.1 Remarks of the Chairman and Principal

14.2 Signature



The above synopsis is scrutinized by P.G Training cum research committee and submitted for registration of subject for the dissertation.




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