wjpmr, 2017,3(3), 153-159 SJIF Impact Factor: 4.103 Rahulkumar et al. Research Article WORLD JOURNAL OF PHARMACEUTICAL AND MEDICAL RESEARCH ISSN 2455-3301 WJPMR THE CLINICAL EVALUATION OF YASHTIMADHU CHURNA WITH MADHU FOR CORRECTION OF PANDUROGA W.S.R. TO IRON DEFICIENCY ANAEMIA AND MEGALOBLASTIC ANAEMIA. 1* Vd. Rahulkumar V. Naika and 2 Dr. V. H. Wankhade 1 PG Scholar, Kayachikitsa Dept, VAM, Amaravati. 2 HOD, Kayachikitsa Dept, VAM, Amaravati. *Corresponding Author: Vd. Rahulkumar V. Naika PG Scholar, Kayachikitsa Dept, VAM, Amaravati. Article Received on 20/01/2017 Article Revised on 09/02/2017 Article Accepted on 01/03/2017 ABSTRACT The main aim of this Ayurvedic medical science is to protect the human beings from various diseases following by rules and regulations of swasthavritta and to have disease free human being to form healthy society. Disease is nothing but, life under altered conditions. These altered conditions in fact manifest themselves through agency of Doshas, Dhatus and Malas in the body. The priority is given to these factors. If they are balanced, the body remains in balanced condition or swastha. If the Doshas are vitiated, then they create any unhealthy condition in the body. The concept of Panduroga is not new for Ayurveda. It is clearly stated that Pittapradhan Vatadi Doshas are the main causes to produce Panduroga. According to similarities in the symptoms we can compare Panduroga with anaemia as described by modern science. Though there has been immense research for cure of this disease in various systems of medicine, this disease still remains a challenge to the medical world. The third national family health survey (NFHS-3) estimates suggest that 56% of women and 70% of children in India have anaemia. In modern medicinal science, there is also good treatment for anaemia with considerable result but that is only for acute deficiency Anaemia s. No significant therapy is there for chronic anaemia which occurs due to metabolic defects. In modern medicine, various form of iron viz, ferrous sulphate, ferrous fumarate, i.v. iron sucrose etc. are commonly used, but these therapies have their noted adverse effects e.g. nausea, vomiting, abdominal pain, diarrhoea or constipation etc. Ayurveda can provide better management for this. So, I have planned to study the efficacy of Yashtimadhu churna with Madhu in Panduroga (anaemia). Yashtimadhu Churna with Madhu will be given orally to the patient. Other details will be described in full paper. KEYWORDS: swathavritta, Panduroga, dosha, anaemia, INTRODUCTION Ayurveda is an ancient medical science reminded by lord bhrama. The main aim of this Ayurvedic medical science is to protect the human beings from various diseases following by rules and regulations of swasthavritta and to have disease free human being to form healthy society. Disease is nothing but, life under altered conditions. These altered conditions in fact manifest themselves through activity of Doshas, Dhatus and Malas in the body. The priority is given to these factors. As said in classical texts rogah sarveapi mandeagnou If Doshas are balanced, the body remains in balanced condition or swastha. If the Doshas are vitiated, then they create any unhealthy condition or roga in the body. Panduroga is described in all available classical texts. It is clearly stated that Pittapradhan Vatadi Doshas are the main causes to produce Panduroga. According to similarities in the symptoms we can compare Panduroga with anaemia as described by modern science. Though there has been immense research for cure of this disease in various systems of medicine, this disease still remains a challenge to the medical world. The drugs which are used by modern medicine gives relief but chances of recurrence are more. Though iron is the third most abundant element yet its deficiency is the commonest nutritional deficiency and a major health problem that is estimated to afflict over two billion people globally. More than half of patients with anaemia are supposed to have iron deficiency. Between 30% and 70% population in the developing world is iron deficient. The third national family health survey (NFHS-3) estimates suggest that 56% of women and 70% of children in India have anaemia. Over half of all cases of anaemia are secondary to iron deficiency. IDA is associated with cognitive impairment, reduced work output and is a significant contributor to increased 153
maternal and perinatal mortality. In modern medicinal science, there is also good treatment for anaemia with considerable result but that is only for acute deficiency Anaemia s. No significant therapy is there for chronic anaemia which occurs due to metabolic defects. In modern medicine, various form of iron viz, ferrous sulphate, ferrous fumarate, i.v. iron sucrose etc. are commonly used, but these therapies have their noted adverse effects e.g. nausea, vomiting, abdominal pain, diarrhoea or constipation etc. Ayurveda can provide better management for this. The main key of treatment of Panduroga is to improve Agnimandya, Shamana of vitiated Pitta dosha and Sthapana(to balance) of Rasaraktadhatu. Yashtimadhu together with Madhu is very effective due to its properties of Rasa, Virya, and Vipaka to subside the structural and functional deformity in Panduroga. So, I have planned to study the efficacy of Yashtimadhu churna with Madhu in Panduroga (anaemia). Yashtimadhu Churna with Madhu will be given orally to the patient. The drug selected under the study Yashtimadhu churna with Madhu is described in Shondhalkrut GADANIGRAHA under the title of PANDUROGAKAMALAKUMBHAKAMALAHALIMAK A CHIKITSA ADHIKAR In this research study total 60 patients with sign and symptoms of Panduroga fulfilling inclusion and exclusion criteria are selected. They are divided into two groups based on pathological variations. Group A is a group of iron deficiency anaemia and group B is a group of Megaloblastic anaemia. Each group has 30 patients of Panduroga. Both groups are intervened by same drug, i.e. Yashtimadhu churna with Madhu in avaleha form. MATERIALS AND METHODS Material used Yashtimadhu powder Honey (Madhu) METHOD OF PREPARATION OF TRIAL DRUG YASHTIMADHU CHURNA WITH MADHU- Preparation of trial drug is done in two stapes 1) Identification & Collection of raw Drugs Yashtimadhu powder: Yashtimadhu powder was identify by using its Gundharma (properties) in Classical text and collected from nearby authorized pharmacy. Madhu: Madhu also were identify by using its Gunadharma in Classical text and then collected, from local Market. 2) Preparation of trial drug 10gm of Yashtimadhu powder and 10gm of Madhu were taken and thoroughly mix with each other till mixture becomes homogenous. The mixture formed finally is in the form of avaleha. Patients were asked to prepare mixture of trial drug at the home for intervention. Clinical study 1. Research study centre Total 60 patients fulfilling the criteria and attending Kayachikitsa OPD or IPD of the concerned institutional hospital were selected for research study. 2. Language of Dissertation Language of dissertation is in English language. 3. Sample size For present study, two groups were selected. Considering zero dropped out 60 patients was selected fulfilling inclusion and exclusion criteria each group having 30 patients. 4. Inclusion criteria Age- 16 years to 60 years Sex Either sex irrespective of religion. Microcytic or Iron deficiency anaemia. Macrocytic or Megaloblastic anaemia. Chronicity less than 5 years. 5. Exclusion criteria Anaemia due to acute or chronic haemorrhage. Congenital or hereditary deformity like Sickle cell or Thalassemia. Hb gm% below 6 gm% Other diseases like Acute or chronic Renal failure, Chronic liver diseases, Endocrine failures like hyper or hypothyroidism, Pregnancy are excluded. Patient having history of worm infestation. Subject not fulfilling the inclusion criteria. 6. Investigations CBC- Hb%, MCV, MCH and RBC count are taken as major objective criteria. Other routine investigations are done wherever necessary to rule out exclusion criteria of present study such as BSL, Thyroid profile, ECG etc. 7. Grouping After selection of patients of Panduroga on the basis of subjective criteria they were grouped under; Group A- iron deficiency anaemia and Group B- Megaloblastic anaemia, this grouping is done according to their CBC report. Their other routine investigations were also done if necessary.\ 8. Safety assessment The drugs used for clinical trial are in human use since thousands of years, hence they are considered as safe for human use. Other studies on trial drug were also been reported to be safe to use for human being. Following parameters were used for safety assessment, 154
Adverse event report Vital signs such as blood pressure, pulse rate, respiratory rate etc. Laboratory investigations if needed. 9. Consent Written and informed consent in understandable language of patient was taken before screening for trial. 10. Case record form- Case taking format is designed for study purpose in detail, in all aspects of disease in Ayurvedic and modern view. All records of patients were taken in that specially designed case record form. 11. Drugs and Posology Patients fulfilling the criteria were selected for study. These patients divided into two groups according to their CBC report. Group A: group of iron deficiency anaemia. Group B: group of Megaloblastic anaemia. Both groups were given same drug for intervention. Dose- 10 gm of Yashtimadhu powder with equal amount of Madhu is thoroughly mixed with each other. Final product formed is in avaleha form. Total 20 gm of avaleha is given orally to the patient. Timings- In the early morning and in evening empty stomach. Study duration- total duration of study is two months. Follow up on 10 th, 20 th, 30 th, 45 th day of study for physiological assessment and any adverse event if happened. 60 th day follow up for final data collection. Preparation of trial drug- patient were given a raw trial drug in packing form and they were asked to prepare a drug at home just before the intervention. Diet: all subjects were advised to take pathyaahar on time according to their agnibala. Avoid paryushitanna and guru ahar. 12. Assessment of Therapy: Total assessment of the therapy was done on the basis of relief in the signs and symptoms as well as an objective criteria value of RBC S, Hb%, MCV, MCH and MCHC like parameters. and after the treatment through statistical analysis and percentage of relief was taken out to assess the efficacy of this clinical trial. All symptoms were graded into two to five grade scales on the basis of severity by using symptom rating scale to assess the changes. Subjective criteria 1. Akshikutashotha- periorbital swelling. 2. Fatigue- Angamarda 3. General debility- Balakshaya 4. Dyspnea on exertion Shrama 5. loss of appetite- Aruchi 6. Pallor Twakpanduta 7. Breathlessness Shwaas 8. Palpitations- Hrutspandan 9. Vertigo- Bhrama 10. pain- Gatrashool objective criteria 1. Hb% 2. MCV 3. MCH 4. MCHC 5. RBC count RESULTS Effect of therapy on clinical parameters It has been explained in the criteria of assessment that the effect of therapy will be evaluated on clinical features by adopting grade system. Each of symptoms and parameters was assessed before of start of trial and after end of trial period. Within geoup analysis Test used for within group analysis, paired t test was applied on all subjective parameters. For all objective parameter Wilcoxon matched- pairs signed rank test was applied. Indications- NS- p> 0.05 not significant *- p < 0.05 significant **- p < 0.01 more significant ***- p < 0.001- Highly significant. The patients were examined on every follow up and suitable scoring pattern and objective parameters were recorded before and after completion of therapy. Subjective criteria. In Ayurveda, most of the symptoms and signs of Panduroga are subjective in nature. For clinical assessment and statistical analysis of therapy scoring for these symptoms is must. This score was obtained before 155
MEAN MEDIAN DEVIATION ERROR SUM P VALUE Twakpanduta Shwas Hrutspandan Bhrama Gatrashool GP BT AT BT AT BT AT BT AT BT AT A 2.333 0.8000 2.033 0.8333 2.267 1.167 2.400 1.167 4.833 2.467 B 1.867 0.4667 1.733 0.6000 2.033 0.9000 1.667 0.5667 4.333 1.833 A 2.000 1.000 2.000 1.000 2.000 1.000 2.000 1.000 5.000 2.000 B 2.000 0.000 2.000 1.000 2.000 1.000 2.000 1.000 4.000 2.000 A 0.4795 0.5509 0.4901 0.5921 0.4498 0.3790 0.4983 0.3790 1.416 1.525 B 0.6814 0.5074 0.4498 0.4983 0.5561 0.6074 0.4795 0.5040 1.184 1.262 A 0.0875 0.1006 0.0894 0.1081 0.0821 0.0692 0.0909 0.0692 0.2586 0.2785 B 0.1244 0.0926 0.0821 0.0909 0.1015 0.1109 0.0874 0.0920 0.2162 0.2304 A 70 24 61 25 68 35 75 35 145 74 B 56 14 52 18 61 27 50 17 130 55 A *** *** *** *** *** B *** *** *** *** *** Table no 1: showing within group analysis of subjective criteria. MEAN MEDIAN DEVIATION ERROR SUM P VALUE Periorbital swelling Angamarda Balakshaya Shrama Aruchi GP BT AT BT AT BT AT BT AT BT AT A 0.4467 0.000 6.500 2.867 2.667 1.233 2.533 2.167 2.167 1.067 B 0.4667 0.100 5.633 2.233 2.433 1.167 2.233 1.933 1.933 0.8333 A 0.000 0.000 6.000 3.000 3.000 2.000 3.000 1.000 2.000 1.000 B 0.000 0.000 6.000 2.000 2.000 2.000 2.000 1.000 2.000 1.000 A 0.5074 0.000 0.9738 0.8996 0.6065 0.7279 0.5074 0.4302 0.4611 0.4498 B 0.5074 0.3051 1.066 0.7739 0.5683 0.7466 0.6261 0.6477 0.3651 0.3790 A 0.0926 0.000 0.1778 0.1642 0.1107 0.1329 0.0926 0.0785 0.0841 0.0821 B 0.0926 0.0557 0.1947 0.1413 0.1038 0.1363 0.1143 0.1183 0.0667 0.0692 A 14 0 195 86 80 37 76 37 65 32 B 14 3 169 67 73 35 67 25 58 25 A *** *** *** *** *** B ** *** *** *** *** Paired t test was applied on all the subjective criteria like akshikuta shotha, Angamarda, Balakshaya, Shrama, Aruchi, twakpanduta, shwas, hrutspandan, Bhrama and Gatrashool. In both group: p value summary for all criteria was found < 0.0001 i.e. highly significant. But the mean values of both the group represents that Group A showed better relief on all subjective criteria than Group B. Table No. 2: Showing within group analysis of objective (laboratory) parameters. MEAN HB% MCV MCH MCHC RBC COUNT GP BT AT BT AT BT AT BT AT BT AT A 8.737 9.647 72.63 79.37 26.30 27.37 26.73 28.88 4.267 4.388 B 8.320 9.253 101.3 93.55 33.16 30.20 30.06 30.76 3.650 3.973 MEDIAN DEVIATION ERROR A 9.000 9.700 72.00 78.00 27.00 28.00 27.00 29.05 4.200 4.500 B 8.000 8.850 100.0 95.00 33.00 30.00 30.00 30.70 3.700 4.000 A 0.8499 0.8823 3.837 4.545 2.049 1.790 1.369 1.424 0.5091 0.3643 B 0.9707 1.133 3.349 3.322 2.453 1.540 1.246 0.9201 0.4718 0.3787 A 0.1552 0.1611 0.7005 0.8297 0.3741 0.3269 0.2499 0.2599 0.0929 0.0665 B 0.1772 0.2068 0.6115 0.6065 0.4479 0.2812 0.2274 0.1680 0.0861 0.0691 156
SUM P VALUE A 262.1 289.4 2179 2381 788.9 821 801.9 866.3 128.01 131.64 B 249.4 277.6 3037 2806.6 994.7 906 901.7 922.9 109.5 119.2 A *** *** *** *** NS B *** *** *** *** *** For laboratory investigation parameters, Wilcoxon matched pairs signed rank test was applied. In group A, p value summery for Hb%, MCV, MCH, MCHC was found < 0.0001 that means it is highly significant except for RBC count where it found non-significant.( p value 0.1877) In group B, p values for Hb%, MCV, MCH, MCHC and RBC count shows highly significant value. Total effect of therapy For the evaluation of total effect of therapy percentage of improvement of each parameter on both groups is calculated. For percentage of relief following formula is used. Average BT- Average AT X 100 Average BT Effect of therapy Group A Group B Complete relief 0 0 Marked improvement 0 0 Moderate improvement 25 subjects or 83.33% 15 subjects or 50% Mild improvement 5 subjects or 16.66% 15 subjects or 50% unchanged 0 0 Graph no 1: Showing total effect of therapy. DISCUSSION Discussion on Drug As per Charakacharya some dravya acts through its Rasa, some acts through its vipaka, veerya, Guna and some through its prabhava. The probable mode of action produced by the drug is better understands with the correlation with its diseases sampraptibhanga, Dosha shamak and Dhatu vrudhhikara properties. Yashtimadhu have a madhura rasa, madhurvipaka and a sheetavirya with Guru snigdhaguna. Madhura Rasa and Vipaka Panduroga caused due to hetus(causes) like atikshar, atilavana, atiamlasevana. Ativyayam, atimaithuna are also major hetus for Panduroga. Due to this, Dhatu kshaya is the main complication of Panduroga. Madhura Rasa and Madhurvipaka acts like a shamak for above hetus. Yashtimadhu is all Dhatu satmya, Bruhana and useful in Dhatu kshaya by its Madhura Rasa. It is jivaniya, Sandhanakara and ojovrudhhikara by its Madhura Rasa and vipaka. SheetaVirya Vitiation of Pittadosha causes Panduroga. Main karma of raktadhatu i.e. Jivanam karma is hampered. Udbhavasthana of Panduroga i.e. Hrudaya is also get weak as there is already Rasarakta Dhatu Dushti and Khshaya.Dushti of Hrudayasthana is also happened by mansikbhava like atichinta, atikrodha as hrudaya is the sthana of mann(mind). Due to sheetavirya of Yashtimadhu, it gives feeling of well-being, increases Jivaniya Karma of Raktadhatu, 157
Rakta Dhatu prasadkara andprashamana of pittadosh. It also gives bala(strenth) to hrudaya as it is jivaniya and shonitasthapana. Guru snighdhaguna Snighdhaguna balances the rukshata in body while Guru guna increases Dharana karma of body. Overall effect of Yashtimadhu churna with honey in Panduroga Panduroga is caused by the hetus like pitta prakopakahara and vihara, ativyayam, atimaithuna or dhatukshayakara hetus. Also due to mansikbhava like atichinta. Atikrodha etc. Yashtimadhu by its Madhura rasa and Madhura vipaka acts as a Pittadoshashamaka and raktaprasadkara. Madhu acts as a sroto-avrodhagna by its property of sookshma and srotoshodhanakara. Dhatukshaya and dhaturokshya is balanced by the property of Madhura rasa and vipaka as well as Gurusnigdhaguna of Yashtimadhu. In combination with Madhu it increases Agnibala as both have property of agnidipana. In this way Yashtimadu with Madhu creates sampraptibhanga of Panduroga and patients of Pandurogi is get benefited. Effect of therapy on clinical parameter/ classical symptoms When paired t test was applied to the symptomatic data, Group A shows statistically highly significant results on all symptoms like Akshikuta shotha, Angamarda, Balakshaya, Shrama etc. Group B also shows statistically highly significant result on all symptoms. But the average percentage relief in group A is 45.57% while in group B is 38.75%. Difference between these two values indicates that the present trial drug shows better result in Group A than group B. Comparison was made between symptoms of both groups by applying an Unpaired t test, it was observed that test was non-significant in all symptoms except Akshikuta shotha where it shows significant value hence present trial drug has more effect in Group A than Group B in that symptom. On the basis of mean values of all other symptoms it is found that trial drug has more effect in Angamarda, Balakshaya, Twakpanduta and Shwas symptoms in group A, while Shrama, Hrutspandan and Gatrashoola like symptoms shows better relief in Group B. symptoms like Aruchi and Bhrama shows equal results in both groups. Effect of therapy on objective parameters/ laboratory values: Objective parameters like Hb%, MCV, MCH, MCHC and RBC count were statistically analyzed. Wilcoxon matched signed rank test was applied for within group data analysis. Within group analysis of data after applying test were shows significant result in both groups except RBC count in group A where it shows statistically nonsignificant result. Between group analysis was done by applying unpaired t test. All the objective parameters shows nonsignificant result except MCH value where it shows significant result and signifies better result in group B than group A. on the basis of comparison of mean values of both groups it is observed that in Hb%, MCV, and RBC counts group B shows better effect than group A, while for MCHC objective parameter group A shows better effect. Overall effect of therapy In the present study, total assessment of the therapy was done based on relief in the signs and symptoms as well as objective criteria. In group A out of 30 patients; 25 patients (83.33%) show moderate relief while 5 patients (16.66%) show mild relief. In group B out of 30 patients; 15 patients (50%) show moderate relief and another 15 patients (50%) show mild relief. By comparing effect of present trial drug in both group it is observed that group A shows better result in improvement of clinical symptoms than group B. On the other hand, though statistically non-significant results were found in many objective criteria s between both groups, but by comparing mean values of both groups; group B shows better effect than group A. CONCLUSION The present study was conducted to assess the effect of Yashtimadhu churna with Madhu in Panduroga w.s.r to iron deficiency anaemia and Megaloblastic anaemia. After a clinical trial, following conclusions are drawn. 1. Anaemia is a major health problem in developing countries. Its prevalence is more in females than men. 2. Treatment of Panduroga is works best when given with planned considerations about pittashamak Rasa, Virya, Vipaka and Rasarakta Dhatu gamitva of the grug. 3. Yashtimadhu churna with Madhu showed better result on all types of Panduroga. 4. Yashtimadhu churna with Madhu showed better result on all the subjective and objective parameters of both types of anaemia i.e. microcytic and Megaloblastic anaemia. 5. Present trial drug increases Hb% in both types of anaemia. 6. There is a definite role of Pathyapathya in the management of Panduroga observed during this study. 7. Ayurvedic treatment gives befitting result in anaemia without any major side effects. 8. Results of this study are very encouraging and trial should be conducted on large sample size. 158
ACKNOWLEDGEMENTS It is beyond the reach of my language to inscribe the profound respect and devotion towards my Parents shri. Vijay k. Naika and Smt. Indu V. Naika for their blessings to me in each and every step. I owe a special debt of gratitude to my guide Dr. V.H. Wankhade, for her able guidance, inspiration during my work. I am thankful to Dr. Sanjay K. Chopkar, Principal, for his momentary support during my work. I love to share the kind memories of my colleagues Dr. Suresh Prajapati, Dr. Prerna Gugaliya, Dr. Sarika Alone, Dr. Sanjay Asutkar, and juniors Dr. Rinku Karda, Dr. Nita Madavi, Dr. Mangesh Malpe for their helping hand. I express my sincere thanks to our librarian Shri. Katkar sir for his kind co-operation. Last but not least, my humble thanks towards hospital staff and my patients without whose co-operation this work could not have been completed. Certain names that have not been mentioned unintentionally who have helped directly or indirectly in his work, thanks to all of them. REFERENCES 1. Charaka Samhita (Hindi.)1 & 2, Dr.Bhramananda Tripathi, choukhambha surbhartiprakashan, Varanasi. Reprint 2011, part 1 and 2. 2. Bhavaprakasha Samhita with vidyotini by Bhishagratna shri Bhramashanakar Mishra, choukhanba sanskrita Bhavan, Varanasi. 11 th ed. 2007 3. Database on Medicinal Plants used in Ayurveda CCRAS. 4. Indian MateriaMedica, Nadkarni, 3rd ed. 1954. 5. Gadanigraha with vidyotini by shriindradevtripathi, choukhamba Sanskrit sansthan, Varanasi. 3 rd ed. 1999. 6. API s text book of medicine, Y. P. Munjal, the association of physicians of India, 10 th ed. 2015. 7. Text book of pathology by Harsh Mohan, jaypee brothers, 6 th ed. 2010. 8. Essentials of medical physiology by K. sembulingam, jaypee brothers publications, 6 th ed. 2012 159