6. brief resume of intended work 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.

• 
  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.
  

• 
  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). 2001^15b.
  
• 
  Effect of Kataka beeja on water borne infections organised in vitro study, Prasad Navaneet ,RGUHS, Banglore.1989^15c
  
• 
  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.
  

• 
  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.
  

2. 
   METHOD OF COLLECTION OF DATA
   

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

• 
  Prospective comparative single blind clinical trial.
  

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.

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

• 
  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
  

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.
   

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
  

• 
  Blood for fasting Blood sugar
  
• 
  Blood for post prandial blood sugar
  
• 
  Urine for sugar
  
• 
  Body weight
  

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?
   

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, 22^nd April 2013.
   
3. 
   Sainani.G.S, API text book of medicine, Vol 1, Chapter 9^th, Munjal YP editor.6^th edition. Mumbai: Jaypee Brothers Medical publishers; 1999.P.988.
   
4. 
   Tripathi.K.D, Essentials of medical Pharmacology, Chapter 19^th. 4^th 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. 2^nd edition. Dehra -Dun: International book distributors; 2008. P.1647.
   
6. 
   Kaiyadeva, Kaiyadeva Nighantu, Oushadhi varga, Chapter 1, P.V.Sharma editor, 2^nd edition, Varanasi, Chaukhambha Orientalia, 2006. P 211.
   
7. 
   Agnivesha, Charaka Samhita, Nidana Sthana, Chapter 4, Shloka 37^th, Jayadeva Vidyalankar Editor, 9^th Edition, Varanasi, Motilal Banarasdas, Reprint 1994.
   
8. 
   Sushruta, Sushruta Samhita, Nidana Sthana, Chapter 6^th ,Shloka 6^th , Jadavji Trikamji Acharya Editor, Varanasi, Chaukambha Sanskrit Samsthan, Reprint 2010,P 291,451.
   
9. 
   Vagbhata, Astanga Hrudaya, Vol 2 Nidana Sthana, Chapter 10^th, Shloka 16, 2^nd 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, 9^th Edition, Varanasi, Motilal Banarasdas, Reprint 1994.
    
12. 
    Sushruta, Sushruta Samhita, Chikitsa Sthana, Chapter 11^th, 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, 2^nd Edition, Varanasi, Krishnadas Academy, 1995, P95.
    
14. 
    Davison”s, Davidson Principles & Practice of Medicine, Chapter 20^th, 21^st Edition, Brain R Walker & Stuart Ralston Editor, Edinburg, Elsevier, 2006, P808.
    
15. 
    Bhagel M S, Researches in Ayurveda, 2^nd 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