1. Welcome to you all
Siddha Medical Symposium , Jaffna, Sri Lanka

2. TITLE:  A Clinical research of Siddha drug “GLY CYN NEU (T)” Ointment for Azhal Vaatham (Neuropathy)
RESEARCHER:
Dr.S.R.Pholtan Rajeev. B.S.M.S (Sri Lanka)
SUPERVISORS :
Dr.U.D.S.Sewwandi. BAMS, Dip in Ayurveda,
M.phil (University of Colombo), BMARI
Siddha Medical Symposium , Jaffna, Sri Lanka

3. INTRODUCTION 1.1-BACKGROUND In commonly patients are suffering from peripheral neuropathy caused by Diabetes Mellitus. We would like to do research in efficacy of ARUGANKATTAI PASTE (GLY CYN NEU Ointment) and Control drug (placebo). Double blind Case control Clinical study measured to assess the effect of the treatment by significant relief of burning sensation within a month.   1.2 RESEARCH PROBLEM Diabetes Mellitus also control by poly herbal drugs even though not efficiency reducing the symptoms of Neuropathy. Therefore this research tries to correct that problem by poly herbal formula.
Siddha Medical Symposium , Jaffna, Sri Lanka

4. OBJECTIVES GENERAL OBJECTIVE:  To relief the Symptoms of Neuropathy in diabetic patients and give healthy life style. SPECIFIC OBJECTIVES: √ To introduce a new Siddha drug for Diabetic Neuropathy. √ To give a new look for herbal formula for Diabetic Neuropathy patient. √ To learn how to do the clinical trial type researches. √ To study about the research analysis with statistical way. √ To gain the knowledge of Research Report writing.
Siddha Medical Symposium , Jaffna, Sri Lanka

5. MATERIALS AND METHODS (METHODOLOGY) Type of Research: Double blind Case Control - Clinical Study. Research area: Bandaranaike Memorial Ayurvedic Research Institute (BMARI) Research period: 02 months Research Samples: 45 patients.   1) Identification of Diabetic Neuropathy patients according to clinically diagnosis. 2) Identify the treatment in Siddha Pharmacopoeia. 3) Literature review. 4) Making for drug sample and check the quality for phyto- chemicals and standardization. 5) Making the final product of the Siddha drug. 6) Clinical test for the drug from 45 patients in OPD and wards and data collecting from a suitable Proforma. 7) Assessment Criteria 8) Analysis of the data and making the thesis.
Siddha Medical Symposium , Jaffna, Sri Lanka

6. LITERATURE REVIEW Disease Review
LITERATURE REVIEW Disease Review Siddha view of Azhal Vatham (Neuropathy) Modern view of Neuropathy Drug Review Glycyrrhiza glabra Cynodon dactylon Coconut oil Bee’s Wax
Siddha Medical Symposium , Jaffna, Sri Lanka

7. Cynadon dactylon Linn. mWfk;Gy; Ethana
Siddha Medical Symposium , Jaffna, Sri Lanka

8. Glicyrhiza glabra Linn mjpkJuk; walmii
Siddha Medical Symposium , Jaffna, Sri Lanka

9. Cocos nucifera Linn. Njq;fha; vz;nza; polthel
Siddha Medical Symposium , Jaffna, Sri Lanka

10. Bee’s Wax Njd; nkOF mee-etti
Siddha Medical Symposium , Jaffna, Sri Lanka

11. DRUG PREPARATION We had prepared Research drug and control drug which as placebo. Conformed the ingredients by Botany section in BMARI. RESEARCH DRUG: Ingredients: Arugampul Cynodan dactylon 20kg Atimaduram Glycyrrhiza glabra 100g Coconut Oil Cocos nucifera 2.5 bottle Bee’s Wax required amount.   Method of preparation: Normal ointment procedures
Siddha Medical Symposium , Jaffna, Sri Lanka

12. CONTROL DRUG : Ingredients: Coconut Oil. Cocos nucifera. 2
CONTROL DRUG : Ingredients: Coconut Oil Cocos nucifera 2.5 bottle Bee’s Wax required amount.   Method of preparation: Same as research drug. Normal ointment procedures.
Siddha Medical Symposium , Jaffna, Sri Lanka

13. Label of Research drug and Control drug
Siddha Medical Symposium , Jaffna, Sri Lanka

14. Research drug, control drug & main ingredient
Similar drug (research drug and control drug) for research samples -patients
Research drug, control drug & main ingredient
Siddha Medical Symposium , Jaffna, Sri Lanka

15. Research drug & Control drug
Siddha Medical Symposium , Jaffna, Sri Lanka

16. Research drug & commonly effected areas (legs & hands)
Siddha Medical Symposium , Jaffna, Sri Lanka

17. Research & Quality Assurance Laboratory, BMARI.
Phyto-Chemical analysis Report of the Research Drug Organoleptic Characteristics: Colour – Green Odour – Coconut Oil smell. Taste – Sweet Physico-Chemical Specifications: Specific gravity – Loss on drying – % Acid Value – Saponification value –
Tested by:
Research & Quality Assurance Laboratory, BMARI.
Siddha Medical Symposium , Jaffna, Sri Lanka

18. CLINICAL STUDY 45 Samples in OPD (Out Patient Department)and wards
CLINICAL STUDY 45 Samples in OPD (Out Patient Department)and wards. and data collecting from a suitable Proforma.   Grouping the Samples: Three (03) groups but all are same symptomatically Diabetic neuropathy condition. Those three groups are given below, Group I : Diabetic neuropathy patients with Hospital internal treatment (DMT).(15 patients) Group II : Diabetic neuropathy patients with Hospital internal treatment (DMT) and Research Drug (GlyCynNeu Ointment) external treatment.(15 patients) Group III : Diabetic neuropathy patients with Hospital internal treatment (DMT) and Control drug treatment.(15 patients)  
Siddha Medical Symposium , Jaffna, Sri Lanka

19. Proforma
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20. Distribution of symptoms of Sample
Siddha Medical Symposium , Jaffna, Sri Lanka

21. ASSESSMENT CRITERIA Symptom analysis analog score
ASSESSMENT CRITERIA Symptom analysis analog score numbered 0 – 10 schedule by pts. Verbal comments. Final Assessment Criteria: 1-High Marked. (but not cured) Marked improvement. 3-Moderate improvement. 4-Mild improvement. 5-Very mild. 6-Not improvement. 7-Aggressive.
Siddha Medical Symposium , Jaffna, Sri Lanka

22. Symptom analysis analog score
Siddha Medical Symposium , Jaffna, Sri Lanka

23. Siddha Medical Symposium - 2012, Jaffna, Sri Lanka

24. Final Assessment 1-High Marked. (but not cured)
2-Marked improvement. 3-Moderate improvement. 4-Mild improvement. 5-Very mild. 6-Not improvement.
Siddha Medical Symposium , Jaffna, Sri Lanka

25. RESULT AND DISCUSSION Final Assessment of hospital D
RESULT AND DISCUSSION Final Assessment of hospital D.M treatment on the clinical symptoms of Diabetic Neuropathy
Siddha Medical Symposium , Jaffna, Sri Lanka

26. Final Assessment of “GlyCynNeu” Ointment treatment on the clinical symptoms of Diabetic Neuropathy
Siddha Medical Symposium , Jaffna, Sri Lanka

27. Final Assessment of Drug Group-III treatment on the clinical symptoms of Diabetic Neuropathy
Siddha Medical Symposium , Jaffna, Sri Lanka

28. CHARTS IN DATA ANALYSISING Progress of the symptoms with treatment of sample group I, II& III
Siddha Medical Symposium , Jaffna, Sri Lanka

29. Siddha Medical Symposium - 2012, Jaffna, Sri Lanka

30. Siddha Medical Symposium - 2012, Jaffna, Sri Lanka

31. STATISTICAL ANALYSIS NEUROPATHIC SYMPTOMS Group-I & Group-II 4th Week (AFTER treatment) level of the samples. The test is significant at (adjusted for ties) Group-I & Group-III End of the research (4th Week level) of the samples. The test is significant at (adjusted for ties) Group-II& Group-III End of the research (4th Week level) of the samples. The test is significant at (adjusted for ties)
Siddha Medical Symposium , Jaffna, Sri Lanka

32. BURNING SENSATION Group-I & Group-II
BURNING SENSATION Group-I & Group-II End of the research (4th Week level) of the samples. The test is significant at (adjusted for ties)
Siddha Medical Symposium , Jaffna, Sri Lanka

33. DISCUSSION &CONCLUSION In final analysis, according to the neuropathic symptoms; burning sensation- very mild grade 46.15% in Group-I (D.M.T), Marked improvement grade 15.38% Moderate improvement grade 38.46% in Group-II (GlyCynNeu Ointment) and mild improvement 23.08%, very mild improvement 07.69% in Group-III than the Numbness, Numbness & Burning sensation.
Siddha Medical Symposium , Jaffna, Sri Lanka

34. In statistical result says, Comparing the control (Group-I), GlyCynNeu Ointment (Group-II)was shown Significant (p<0.05) reduction in symptoms of neuropathy. One month (4th Week) of treatment with GlyCynNeu Ointment significantly (p<0.05) change symptoms of neuropathy with the control group (group-I). Finally, we concluded effectiveness of our research drugs GLY CYN NEU Ointment most effective than Drug Group-III and Hospital Diabetic treatment (Group-I) for Diabetic Neuropathic symptoms. In neuropathic symptoms, BURNING SENSATION was highly notified changes like reducing within one a month than other symptoms
Siddha Medical Symposium , Jaffna, Sri Lanka

35. References Text references: 1) Ramanathan
References Text references: 1) Ramanathan.P, MD(s), ‘Siddha Pharmacopoeia’, All Sri Lankan Siddha Ayurveda Medical Officers’ Union, Sri Lanka, 1st Edition-2000, page No: ) Narayanaswami.V, HPIM, ‘Pharmacopoeia of Hospital of Indian Medicine – SIDDHA’, Tamil Nadu Siddha Medical Board, Madras , 2nd Edition-1995, Page No: 29. 3) Murugesamuthaliyar.K.S, “Gunapadam- Mooligaithokuppu” (1st Part), University of Indian Medicine, Madras , 3nd Edition- 1936, page no:09, 10, 36, 37,383, 384, 385, ) Thiyagarajan.R, L.I.M, “Gunapadam- ThadhuJeevaVakuppu” (2nd& 3rd Part), Indian Medicine, Department of Homeopathy, Madras , 2nd Edition, 2003, page no: ) Ponnaiyah.I,“Sekarasasekaravaiththiyam” Provincial Department of Indigenous Medicine, North-East Province, Sri Lanka, 2000, page no: 115, 116,   Electronic References: Internet: Statistical software: Minitab.
Siddha Medical Symposium , Jaffna, Sri Lanka

36. Thank You
Siddha Medical Symposium , Jaffna, Sri Lanka

37. Do RESEARCHES about SIDDHA & enjoy with that !!!!!!!!!
Siddha Medical Symposium , Jaffna, Sri Lanka