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1. COMBINED EFFECT OF MULETHI CHURN AND KAMDUDHA RAS IN THE MANAGEMENT OF AMLAPITTA(HYPERACIDITY) Prepared by; Dr. Vinod Rawat Final Year PG Scholar PG Studies in Dept. of Kayachikitsa Patanjali Ayurvedic College Haridwar, Uttrakhand-249405

2. रागादिरोगान् सततानुषक्तानशेषकायप्रसृतानशेषान्॥१॥ औत्सुक्यमोहारतिदान् जघान योऽपूर्ववैद्याय नमोस्तुतस्मैः Supervised By: Dr. C.B. Dhanraj Professor M.D., M.P.H(England) CPHEC(USA), Ph.D. Co-Supervised By: Dr. Avinash Kumar Srivastava Assistant Professor M.D.

3. INDEX INTRODUCTION EPIDEMIOLOGY NEED OF STUDY AIMS AND OBJECTIVE AYURVEDIC LITERATURE REVIEW DRUG REVIEW MATERIALS AND METHOD OBSERVATION RESULTS DISCUSSION CONCLUSION RECOMMENDATION

4. INTRODUCTION Amlapitta is not considered as a separate disease in Bruhata trai , is mentioned as a symptom in numerous places by Acharya Charaka . Acharya Kashyapa was the first to provide a detailed description of the disease and analyze it on the basis of Doshas . W hile Acharya Madhavakara described the disease in detail and classified it based on Gati , namely Urdhvaga Amlapitta and Adhoga Amlapitta . Due to various factors like environmental changes, erroneous food habits, incompatible food habits, change in methods of cooking. These factors result in imbalance in pitta. This condition leads to Amlapitta .

5. EPIDEMIOLOGY The prevalence of Hyperacidity in India ranges from 7.6% to 30%. The dietary factors associated with Hyperacidity include use of spices and non-vegetarian food. The prevalence of GERD varies greatly over the world, ranging from 2.5 to 7.8% in East Asia, 8.7-33.1% in the Middle East, 8.8-25.9% in Europe, 18.1-27.8% in North America, 23.0% in South America, and 11.6% in Australia. However, the true prevalence of this disorder could be higher because more individuals have access to over-the-counter acid, reducing medications.

6. NEED OF STUDY Modernization is believed to be the most common cause of Amlapitta , which is considered as one of the major emerging life style disorder. Due to hurry, worry, & with faulty dietary habits greatly affect our life style and so as our Jatharagni . In modern science, drug therapy involved in Hyperacidity are drugs which reduces gastric acid secretion (like H2 receptors antagonists, PPI), mucosal protective agents, antacids, ulcer healing drugs, antibiotics for H. pylori eradication. But these drugs have their own side-effects, the antacids are among the one of the most widely used medicine all over the world. Food and drug Administration (FDA) warned that there is increase risk of fractures with the use of Proton Pump Inhibitor.

7. NEED OF STUDY All above the reasons we need an Ayurvedic herbal drugs which is safe, easily available in market, easy to take and cost-effective in present time for research on this topic; therefore, it was chosen for research study. Therefore, In this study I have selected Mulethi churn and Kamdudha Ras in the management of Amlapitta (Hyperacidity).

8. AIMS AND OBJECTIVE To evaluate the efficacy of combined effect of Mulethi Churn and Kamdudha Ras in Amlapitta . To gain Conceptual and Clinical studies about Amlapitta . To know the side effects of Mulethi Churn and Kamdudha Ras.

9. Ayurvedic literature review VEDIC KALA There is no evidence found in vedic literature. SUSHRUTA SAMHITA Acharya Sushruta states in Sutra sthana (Su.su.42/9) that excessive consumption of lavana rasa leads to the manifestation of symptoms similar to Amlika , which resembles Amlapitta . However, the term Amlapitta is not explicitly mentioned in the Samhita. CHARAK SAMHITA Amlapitta is not mentioned as separate disease by Acharya Charak .

10. Ayurvedic literature review SHARANGADHARA SAMHITA Sharandhara did not provide a detailed description of Amlapitta . KASHYAPA SAMHITA The Kashyapa Samhita is the first available text that provides a comprehensive description of Amlapitta as a distinct medical condition and its corresponding treatment. BHELA SAMHITA There is no description of Amlapitta

11. SYMPOTMS KASHYAPA SAMHITA विड्भेदोगुरुकोष्ठत्वमम्लोत्क्लेशःशिरोरुजा । हृच्छूलमुदराध्मानमङ्गसादोऽन्त्रकूजनम् ॥ कण्ठोरसी विदह्येते रोमहर्षश्च जायते ।   सामान्यलक्षणं त्वेतद्विशेषश्चोपदेक्ष्यते ॥ ( K.S.Khi.16/14-15) MADHAVA NIDANA अविपाकक्लमोत्क्लेशतिक्ताम्लोद्गारगौरवैः।   हृत्कंठ दाहारूचिभिश्चाम्लपित्तं वदेद्भिषक् ॥ ( M.N.51/2 )

12. DRUG REVIEW of mulethi Acharya Charak mentioned Yashtimadhu in Shonit sthapan Mahakasaya मधुमधुकरुधिरमोचरसमृत्कपाललोध्रगैरिकप्रियङगुशर्करालाजा इतिदर्शमानिशोणितस्थापन भवन्ति (च.सू. 4/46 )

13. DRUG REVIEW of mulethi Acharya Sushruta mentioned Yashtimadhu in Sarivadi Gana सारिवामधुकचन्दनकुचन्दनपद्मककाश्मरीफलमधूकपुष्पाण्युशीरञ्चेति सारिवाऽऽदिः पिपासाघ्नो रक्तपित्तहरोगणः पित्तज्वरप्रश्मनों विशेषाद्दाहनाशनः( सु.सू 38/39-40 )

14. DRUG REVIEW of kamdudha ras Rasyoga Sagar मौक्तिकस्य प्रवालस्य मुक्ताशुत्तिभवस्य च वराटिकायाः शङ्खस्य भस्मानि गैरिकं तथा ।। गुडूचिकोद्भवं सत्त्वं समभागानि कारयेत्। ( र.यो.सा. )

15. DRUG REVIEW of kamdudha ras Rasyoga Sagar DRUG NAME BOTANICAL   NAME RASA GUNA VIRYA VIPAK 1. MotiPishti Pearl Madhura Sheeta Sheeta Madhura 2.PravalPishti Coral Madhura Laghu Sheeta Madhura 3.Mukta shukti   Pishti Oyster/Pearl Madhura Sheeta , laghu snigdha Sheeta Madhura 4.Varatika Bhasma Cowry/Marine shell Katu,Tikta Guru, Ushna Ushna Katu 5.Shankha Bhasma Conchshell CaCO3 Kashaya, Katu , kshara Grahi Sheeta Madhura 6.Swarnagairika Ochre / Haemetite Madhura, Kashaya Snigdha Sheeta Madhura 7.Giloy satva Tinosporia cordifolia Tikta , Kashaya Guru,   Snigdha Ushna Madhura

16. DRUG REVIEW DRUG NAME RAS GUNA VIRYA VIPAKA MULETHI MADHUR GURU,SNIGDH SHEETA MADHUR KARMA OF MULETHI-VATAPITTANASAKA,RAKTAPRASADANA,BALYA,VARNYA,VRISHYA.

17. MATERIALS AND METHODS Selection of Patients 1.A series of 40 patients on the basis of classical symptomatology of Amlapitta were selected 2.Randomly for this clinical study 3.Irrespective of sex, religion and occupation etc. from O.P.D and I.P.D. of P.G. Dept. of Kayachikitsa , Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar. Selection of Sample:- Random Sampling Type of Study:- Open clinical trial

18. MATERIALS AND METHODS INCLUSION EXCLUSION CRITERIA FOR WITHDRAWAL Patients having age between 20yrs. to 70yrs. Patients will be selected as per classical signs and symptoms of Amlapitta . Aggravation of Symptoms LAMA Inter Current Illness. Patient below 20yrs. and above 70 yrs Diagnosed cases of H. pylori infection. Patients having uncontrolled diabetes, cardiac problems, tuberculosis, malignancy etc.

19. MATERIALS AND METHODS Plan of Study No. of patients for the drug trial 40 Group of studies Single Follow up period After 15 days No. of follow ups 2 Duration of Study 1 Month

20. Assesment Criteria S. No. Clinical Features Gradings Before Treatment After 15 Days After 30 Days 1. AVIPAKA No Avipaka-0 Digests normal usual diet in 09 hours-1 Digests normal usual diet in 12 hours-2 Digests normal usual diet in 24 hours or more-3 - - - 2. TIKTA and AMLA UDGARA No sour and bitter belching – 0 Sour and bitter belching after taking spicy food -1 Sour and bitter belching afterhaving any type of food -2 Sour and bitter belching having no relation with food- 3 - - - 3. GAURAV NO heaviness -0 Heaviness after taking more quantity of food -1 Heaviness even after taking light food -2 Heaviness even on emptystomach-3 - - - 4. ARUCHI No Aruchi-0 Eating food only two times without any snacks in between -1 Eat only once -2 Have no feeling of appetite-3 - - - 5. SHIRORUKA ABSENT-0 Occasionally-1 Almost daily-2 Throughout the day,need medication-3 - - -

21. ASSESSMENT OF OVERALL EFFECT OF THE THERAPY Percentage improvement of each patient was calculated by the following formula: Total BT-Total AT × 100 Total BT The result thus obtained from individual patient were categorized according to the following grades: No improvement < 25% improvement Mild improvement > 25% to <50% improvement   Moderate improvement > 50% to 75% improvement   Marked improvement>75% improvement Complete improvement – 100% improvement (cured)

22. Statistical Analysis Null Hypothesis Mulethi churna and Kamdudharasa ( Mauktika yukta ) is not effective in the management of Amlapitta ( Hyperacidity ). Alternative Hypothesis Mulethi churna and Kamdudharasa ( Mauktika yukta ) is effective in the management of Amlapitta . Wilcoxon Signed Rank test For evaluating subjective parameters in single group. The obtained data was subjected to various tests. All subjective parameters, showed that results are extremely significant as the p value is approximately less than 0.0001 % in all five parameters.

23. Statistical Analysis Significance was considered as mentioned below: P value Result P > 0.05 Not significant P = 0.01-0.05 Significant P=0.001-0.01 Very Significant P = 0.0001-0.001 Highly Significant P <0.0001 Extremely significant

24. Registered patient Total 40 Patients were selected in this study, among them 33 Patients had completed the treatment and 07 patients were discontinued, LAMA.

25. Age wise distribution

26. gender wise distribution Total 40 Patients were selected in this study, among them 22 Patients were Female and 18 Patients were Male.

27. APPETITE wise distribution Total 40 Patients were selected in this study, among them 18 Patients had Average appetite, 14 pt. had Good appetite and 8 pts. Had Less appetite.

28. DIET wise distribution Total 40 Patients were selected in this study, among them 21 Pts. Had Mixed diet and 19 pts. Had Vegetarian diet.

29. DIETARY HABITS wise distribution Total 40 Patients were selected in this study, among them 23 pts. Had Irregular diet and 17 had Regular diet.

30. ADDICTION wise distribution Total 40 Patients were selected in this study, among them 14 pts. Had NO addiction, 7 pts. Had Alcohol addiction, 5 had Smoking , 10 had Tea/coffee and 4 had Tobacco add iction .

31. NATURE OF WORK wise Total 40 Patients were selected in this study, among them 9 pts had Heavy ,8 had Moderate , 21 had Sitting , 2 pts. Had Standing nature of work.

32. NADI wise distribution

33. MALA wise distribution Total 40 Patients were selected in this study, among them 27 pts. Had Saam mala and 13 pts had Niraam mala.

34. PRAKRITI wise distribution

35. VAYA wise distribution Total 40 Patients were selected in this study, among them 33 pts. were Youvan and 7 pts. Were Vriddha .

36. SATMYA wise distribution Total 40 Patients were selected in this study, among them 35% pts taken Lavana Ras, 28% pts- Katu Ras, 15% pts-Amla Ras, 15% pts- Madhur Ras, 5% pts- Kashay and 2%pts-Tikta Ras.

37. Difference b/w bt&AT mean

38. Statistical analysis of symptoms Symptoms  Mean Median SD Wilcoxon W P-Value % Effect Result BT AT BT AT BT AT AVIPAKA 2.03 0.48 2.00 0.00 0.95 0.67 -4.622 b 0.0000038 76.12 Sig TIKTA AMLA UDGAAR 2.21 0.58 2.00 0.00 0.96 0.66 -4.656 b 0.0000032 73.97 Sig GAURAV 1.67 0.39 2.00 0.00 1.08 0.50 -4.344 b 0.0000140 76.36 Sig ARUCHI 1.18 0.30 1.00 0.00 1.04 0.47 -3.954 b 0.0000770 74.36 Sig SHIRORUKA 1.15 0.27 1.00 0.00 1.20 0.45 -3.874 b 0.0001071 76.32 Sig

39. Percentage of effect Parameter % Effect AVIPAKA 76.12 TIKTA AMLA UDGAAR 73.97 GAURAV 76.36 ARUCHI 74.36 SHIRORUKA 76.32 Average % Effect 75.43

40. Overall effect OVERALL EFFECT Frequency Percentage Marked Improvement 15 45.45% Moderate Improvement 16 48.48% Mild Improvement 2 6.06% No Improvement 0.00% Total 33 100.00%

41. discussion

42. DISCUSSION on observation AGE Above AGE WISE table indicates that age groups mainly involves college going and office going people, which due to the modern life style and fast disturbed habits of food, sleep, mental status with increasing demands of social scenario which negatively affects the digestive system. These things causes development of struggle for life giving them more stress and anxiety leading towards Amlapitta . GENDER In our study, Male pts. Were 45% and Female pts. Were 55%. Females, whether they are housewives, office workers, or college students, have a tendency to neglect their health and engage in unhealthy habits such as irregular intake of nutritious food and experiencing stress and anxiety. This may be attributed to the belief that females are more emotionally vulnerable compared to males, owing to the hormonal changes that occur within their bodies. RAS 35% of the people in our study were taking Lavana Ras, so they were more likely to have Amlapitta . And only 2% people were consuming Tikta Ras, because Tikta Ras is opposed to the properties of Pitta, hence there is a possibility of them getting Amlapitta .

43. DISCUSSION on RESULT In subjective parameters, the above study shows that maximum relief was found in the symptom Gaurav i.e. 76 .36% and thus considered as extremely significant as p<0.0001. In the symptom Shiroruka the relief is 76.32% and thus found Highly significant as P=0.0001-0.001. In symptom Avipaka 76.12 % relief was observed and also found extremely significant as the p<0.0001. Aruchi the relief was 74.36 %, found extremely significant as the p<0.0001. In symptom of\ Tikta-amla udgaar the relief was 73.97% found extremely significant as the p<0.0001.

44. conclusion A critical literary review reveals that Amlapitta can be correlated with Hyperacidity on the basis of similarities of signs & symptoms. Disturb dietetic pattern, mental stress and strain are responsible for the development of gastric dyspeptic disorders and root cause of this is our digestion. The hurry worry curry should keep apart in order to lead a disease free life.

45. recomendation A large number of patient samples can be included in the study, comprising more than 60 patients. Two separate groups can be formed to investigate the comprehensive efficacy of a specific drug in various aspects. A thorough evaluation of the manovaha srotasa can be incorporated into the proforma. A comparative study can be conducted between two groups: one receiving lifestyle modifications and the other receiving an Amlapitta nashaka drug. An examination of the effectiveness of shodhana and shaman chikitsa (treatment) for Amlapitta can be carried out. A controlled study to compare the treatment outcomes of a modern treatment regimen with an Ayurvedic formulation can be undertaken .