Impact factor: 0.3397/ICV: 4.10 1 Pharma Science Monitor 6(3), Jul-Sep 2015 PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES Journal home page: http://www.pharmasm.com A CLINICAL STUDY TO EVALUATE THE EFFECT OF CHITRAKA VATI ON PITTAJA AGNIDUSHTI (PACHAKA PITTA) Bharat L. Bhadiyadra 1 *, R. R. Dwivedi 2, A. S. Baghel 3 1 Final year M.D. Scholar dept of Basic principles, IPGT & RA, GAU, Jamnagar 2 Prof. & Head, Department of Basic Principles, IPGT & RA, GAU, Jamnagar 3 Associate Prof., Department of Basic Principles, IPGT & RA, GAU, Jamnagar ABSTRACT In Ayurvedic treatment, more importance is given to Agni. Normal functioning of Agni depends on Pitta Dosha (Pachaka Pitta). Vitiated Pachaka Pitta is the important cause of Pittaja Agnidushti. Which have symptoms like decreased Abhyavaharana and Jaranasakti, Udaragaurava, Udarashula, Amlodgara, Aruchi, Praseka, Chhardi, Malavarodha etc. inter relation between Agni and Vayu Mahabhuta is well explained in classics. Aim of our study was to evaluate the effect of Chitraka vati as for the treatment of Pittaja Agnidushti (Pachaka Pittadushti) Patients having signs and symptoms of Pittaja Agnidushti attending O.P.D of Basic Principles department, IPGT&RA hospital, Jamnagar having the age between 20 55 years. Observations obtained during the study reveal, that main causative factors of Pittaja Agnidushti are responsible for augmentation of Drava and Ushna (hot) properties of Agni. In patients treated with Chitraka vati and highly significant results were seen all the cardinal symptoms of Pittaja Agnidushti, Udaragaurava (78.79 %), Jaranasakti (70.96 % ), Abhyavaharana shakti (70 %).As per assumption, Chitraka vati gave better efficacy on Pittaja Agnidushti as well as in pacification of vitiated Pachaka Pitta while Placebo showed comparatively less efficacy. KEYWORDS: Agni, Chitrak, placebo, Pachaka Pitta, Ruksha. INTRODUCTION Ayurvedic classics believe that Agnidushti (impaired digestion) is the root cause of all the diseases [1]. Pitta Dosha especially Pachaka Pitta is one of the important factor which is responsible for normal functioning of the Jatharagni [2]. When vitiated Pachaka Pitta influences Jatharagni, it hampers the normal process of digestion and condition thus produced called as Pittaja Agnidushti (impaired digestion due to vitiated Pachaka Pitta ). Pittaja Agnidushti have sign and symptoms like decreased Abhyavaharana shakti, decreased Jaranasakti, Udaragaurava, Udarashula, Amlodgara, Aruchi, Praseka, Chhardi, Malavarodha etc. [3], Causative factors like snigdha, drava, and guru Guna Yukta Ahara Sevana, Divaswapa, Vishamashana etc [4, 5].
Impact factor: 0.3397/ICV: 4.10 2 According to the conceptual part of the research work entitled Study on Panchabhautika Conjugation and Configuration of Panchadha Pitta, it is postulated with evidence that Pachaka Pitta has predominance of Ruksha Guna (among the other Pitta Gunas) due to predominance of Vayu Mahabhuta in its configuration (after Teja and Jala Mahabhuta). Predominant, Vayu Mahabhuta potentiates specifically Ruksha Guna. Hence clinical study is based on hypothesis, Do Pachaka Pitta possess predominance of Agni and Vayu Mahabhta in it? For this the disease condition of Pittaja Agnidushti was selected which is produced by vitiation of Pachaka Pitta with Drava and sheeta Guna. The condition of Pittaja Agnidushti should be relieved more effectively by drug having predominance of opposite Ruksha, Ushna Guna. Hence clinical study is conducted by giving Chitraka vati in group A and Placebo tab in group B for assessment through the Upashaya-Anupashaya. Aim & objective: To evaluate the efficacy of Chitraka vati as Deepana, Pachana and to normalise the function of Pachaka Pitta and have Agni and Vayu Mahabhuta dominancy. Ethical Clearance: Study was approved by Institutional Ethics Committee, wide letter no. PGT/7-A2013-2014/1767 Dated: 28/04/2014 CTRI Registration: This Clinical trial is registered in Clinical Trial Registry of India (CTRI), CTRI REF/2014/05/006917 [Registered on: 05/05/2014] - Trial Registered Retrospectively MATERIALS AND METHODS Patients having the clinical signs and symptoms of Pittaja Agnidushti attaining the O.P.D. and I.P.D. of I.P.G.T. & R.A. were selected without any bar of cast, religion, occupation and sex. Research Design: It was an open comparative clinical trial. Special Research proforma was prepared. Criteria for selection: Patients suffering from the signs and symptoms of Pittaja Agnidushti. Patients having the age between 25 60 years. Criteria for exclusion: Patients having age less than 20 yrs. and more than 55 yrs. Patients suffering from any other systemic disease. Patients having any established pathology of Mahasrotas.
Impact factor: 0.3397/ICV: 4.10 3 Grouping and sampling: Patients were randomly divided in two groups. Patients of Group A were administered with Chitraka vati in dose of 500mg 2 tab twice a day at Samana Kala (just before the meal) with luke warm water Anupana for the duration of 15 days. Patients of group B received Placebo Tab with dose 500mg 2 tab twice a day with luke warm water at Samana Kala for the duration of 15 days. Investigations: Routine pathological tests as blood, urine, stool etc. were carried out to assess the actual status of patient and to rule out any other pathology. Assessment criteria: The assessment was done on the basis of relief found in the cardinal signs and symptoms of the disease before and after treatment. Percentage improvement in the sign and symptoms has been assessed by scoring and grading pattern. The following criteria were made to assess total the effect of therapy. Total effect of therapy: Complete Remission: 100 % relief Marked Improvement: 76-99 % relief Moderate Improvement: 51-75% relief Mild improvement: 26-50% relief Unchanged: 0-25% relief (no relief) OBSERTABONS & RESULTS Total 30 patients were registered in this and all the 30 patients completed the treatment. Among 30 patients, maximum patients belonged to 20-35 age group (76.66 %) and males (60 %). The maximum patients in this study were having Guru Guna(70 %), Sheeta Guna (50%) and drava Guna (47%) dominant Ahara. Diet amount was Hina Matra (40%), no fixed time for consuming the food (47%), Vishamashana (100%), Adhyashana (86.67%), taking water before food (67%), Divaswapa (56.67%), Kshudha and Purisha Vegavidharana (63%). Maximum patients had unsatisfactory evacuation of their bowl (77%), irregular bowel habit (73%). Avara Jaranashakti (100%), Avara Abhyavaharana Shakti (100 %). In maximum patients there was sudden onset (67%), course was occasional (70 %). The symptoms of Pittaja Agnidushti observed among the patients of both groups were decreased Abhyavaharana Shakti (100%), decreased Jaranasakti (100%), Udaragaurava (100%) and associated symptoms like Udarashula (93.33%), Amlodgara (90%), Malabaddhata (100%), Aruchi (76.66%) (Table no.1).
Impact factor: 0.3397/ICV: 4.10 4 Effect of Chitraka tab: In patients of Group A, highly significant results were seen in decreased Abhyavaharana Shakti (70%), decreased Jaranasakti (70.96%), Udaragaurava (78.79%), Udarashula(94.45%), Aruchi(55.56%), Amlodgara(65.63%) and Malabaddhata (65.52%). (Table 2) Effect of Placebo tab: In Group B, significant results were seen in decreased Abhyavaharana Shakti (37.5%), Udaragaurava (48%), Malabaddhata (40.75%), Udarashula(64.29%) and significant results were seen in decreased Jaranasakti (22.59%), Aruchi(20%) and Amlodgara(31.04%).(Table 3,4) On comparison between two groups, Chitraka tab (group A) showed highly significant results in decreased Abhyavaharana Shakti, Udaragaurava, Malabaddhata, Udarashula as compared to Placebo tab (group B). Chitraka tab showed significant results in Aruchi, Amlodgara and Malabaddhata as compared to Placebo tab. (Table 5) In overall effect in Chitraka vati (group A), 46.66% patient got moderate improvement while 6.66 % patients got complete remission and 40% patients got marked improvement and no unchanged. In Placebo tab (group B), 26.67% patients remain unchanged, 53.33% patients got mild improvement, 6.66% patients got moderate improvement and no complete remission. (Table 6) DISCUSSION: In this study, maximum patients belonged to 25-35 years of age group (76.66%), People of these groups are very less and all the middle age between only where selected have there is no relation of age with disease. In this age group they might be not following the proper dietary regulations due to young age. Maximum patients were males (60%), it reveals that males are more prone to irregularities in diet, lifestyle due to responsibility of family. Maximum 66.67 % patients were taking Guru Guna Pradhana diet. 50%, 47 % and 43.77 % patients were taking, Sheeta, drava and Snigdha Guna Pradhana diet respectively. All these Guna responsible for vitiation of Pitta (Pachaka Pitta) and thus leads to disturbed function of Pachaka Pitta. Maximum i.e. 40 % patients had not specific diet amount, it signifies vitiation of Pitta Dosha. As in Pittaja Agnidushti, Jatharagni doesn t get proper stimulation by vitiated Pachaka Pitta hence diet amount of maximum patients was not fixed. Due to Vishamashana (100%), Agni become feeble and doesn t digest the food properly. In maximum patients, food intake time was not fixed (46.66%), due to their occupation or lack of health awareness. Maximum patients were taking cold water before food (30%), which directly leads to Agnidushti [6]. Maximum patients had history of Divaswap (56.66%) which is one of the causative factor for vitiation of Pitta. And
Impact factor: 0.3397/ICV: 4.10 5 vitiated Pitta gives irregular stimulation to Agni which leads to Pittaja Agnidushti. Kshudha Vegavidharana (63%) is also cause Pachaka Pitta vitiation and thereby Pittaja Agnidushti. Maximum patients had unsatisfactory evacuation of their bowl (77 %), irregular bowel habit (53%), this data indicates that Pittaja Agnidushti has very distinctive relation with the bowel and it affects the bowel quite often. Data showed that Avara Jaranashakti found in 100%, Avara Abhyavaharana Shakti in 100%, in Pittaja Agnidushti, person is not willing for the food and it results into reduction in Abhyavaharaṇa Shakti. Further due irregular and feeble state of Agni, the food consumed is not getting digested properly i.e. the Jaranashakti also gets hampered. In maximum patients there was more than gradual sudden(66.7%), course was occasionally (70 %), this data reveals that most of patients ignoring the Pittaja Agnidushti condition as minor health problem due to lack health awareness. The 100 % patients were suffering from symptoms like decreased Abhyavaharana shakti, decreased Jaranasakti, Udaragaurava. This indicates that these are the cardinal symptoms of Pittaja Agnidushti. In this study, the percentage relief observed was higher and statistically highly significant in patients treated with Chitraka tab (Group A). This data supports the hypothesis that Pittaja Agnidushti is the condition caused by vitiation of Pachaka Pitta with Vayu Mahabhuta predominance (along with Agni and Jala Mahabhuta ) in it and hence comparatively better effect was obtained by Chitraka tab having Agni and Vayu Mahabhuta (similar to Pachaka Pitta). In patients treated with Placebo Tab (Group B), the absence of Agni and Vayu Mahabhuta dominancy in Placebo tab makes it incapable to act on Pittaja Agnidushti effectively, hence percentage relief obtained in group B was less. Though the results in Group B are looking statistically highly significant in case of some symptoms but they are may be due to luke warm water which was given as Anupana and also might be due to the general instructions of Pathya-Apathya Nidanaparivarjana and also psychological effect, in both the groups. CONCLUSION From the present study it can be concluded that Chitraka Tab and Tab have Deepana, Pachana actions but Shuddha Ghrita is more effective than Placebo Tab in Pittaja Agnidushti by virtue of its Agni and Vayu Mahabhuta predominance in it. From this it is interpreted that in Pittaja Agnidushti, Pachaka Pitta is predominantly vitiated with its Drava, shita Guna and having predominance Vayu Mahabhuta along with Agni and Jala Mahabhuta.
Impact factor: 0.3397/ICV: 4.10 6 Table 1: Effect of Chitraka vati on chief complaints (Group A) Chief N % Mean S. D. S. E. t P Complaints Relief B.T. A.T. Abhyavaharana shakti 15 70 2.67 0.87 0.75 0.20 9.72 < 0.001 Jaranasakti 15 70.96 2.07 0.60 0.64 0.17 8.87 < 0.001 Udaragaurava 15 78.79 2.2 0.47 0.80 0.21 8.88 < 0.001 Table 2: Effect of Chitraka vati on associated complaints (Group A) Associated N % Mean S. D. S. E. t P Complaints Relief B.T. A.T. Udarashula 14 94.45 1.29 0.08 0.43 0.12 10.67 <0.001 Aruchi 14 55.56 1.29 0.58 0.62 0.17 4.38 <0.001 Praseka 2 66.67 1.5 0.50 0 0 - - Malavarodha 15 65.52 1.94 0.67 0.71 0.19 6.98 <0.001 Chhardi 1 100 1.000 0 - - - - Amlodgara 14 65.63 2.29 0.79 0.95 0.26 5.97 <0.001 Ashudhda Udagara 4 100 1.25 0 0.50 0.25 5 <0.01 Table 3: Effect of Placebo Tab on chief complaints (Group B) Chief N % Mean S. D. S. E. t P Complaints Relief B.T. A.T. Abhyavaharana shakti 15 37.5 2.14 1.34 0.41 0.10 7.483 < 0.001 Jaranasakti 15 22.59 2.07 1.60 0.17 0.17 2.83 = 0.031 Udaragaurava 15 48 1.67 0.8 0.78 0.2 4 = 0.002 Table 4: Effect of Placebo Tab on associated complaints (Group B) Associated Complaints N % Relief Mean S. D. S. E. t P B.T. A.T. Udarashula 14 64.29 1.000 0. 36 0.50 0.14 4.84 <0.001 Aruchi 9 20 1.12 0.89 0.45 0.15 1.52 =0.500 Praseka 2 66.66 1.50 0.50 0 0 0 - Malavarodha 15 40.75 1.80 1.07 0.60 0.16 4.78 <0.001 Chhardi 1 100 1.000 0 - - - - Amlodgara 13 31.04 2.24 1.54 0.64 0.18 3.96 <0.01 Ashudhda Udagar 1 50 2 1 - - - -
Impact factor: 0.3397/ICV: 4.10 7 Table 5: Comparative effect of therapy on chief and associated complaints in both groups Symptoms Df Mean Diff. t P Gr. A Gr. B Abhyavaharana shakti 30 1.86 0.80 0.800 4.733 < 0.001 Jaranasakti 30 1.46 0.46 0.800 4.320 < 0.001 Udaragaurava 30 1.73 0.80 0.733 3.556 = 0.001 Udaragaurava 30 1.73 0.80 0.733 3.556 = 0.001 Udarashula 28 1.21 0.64 0.333 1.784 = 0.085 Aruchi 23 0.71 0.22 0.400 2.479 = 0.019 Praseka 4 0.50 1 0.371 1.876 = 0.074 Malavarodha 30 1.26 0.73 0.200 0.577 = 0.580 Chhardi 2 1 1 0.125 0.436 = 0.670 Amlodgara 27 1.50 0.69 0.000 0.000 = 1.000 Ashudhda Udagara 5 1.25 1 - - - Table 6: Total effect of therapy Category Group A Group B N % N % Unchanged 0 0 4 26.67 Mild improvement 1 6.66 8 53.33 Moderate improvement 7 46.66 1 6.66 Marked improvement 6 40 0 0 Complete Remission 1 6.66 0 0 REFERENCES 1. Vāgbhaṭa, Aṣṭānga Hṛdaya, Nidanasthana, Udaranidanam Adhyaya, 12/1, edited by Pt. Hari Sadashiva shastri Paradakara Bhiṣagacharya, reprint edition, Chaukhamba Surbharati Prakashana, Varanashi 2011; 513. 2. Ibidem (1), Aṣṭānga Hṛdaya, Sūtrasthāna, Doṣabhedīya Adhyāya, 12/10-12; 193. 3. Mādhavakara, mādhava nidānam Part number - 1, Agnimāndyājīrṇavisūcikālasakavilambikānidānam, 6/4, edited by prof. Yadunandana Upadhyaya, Reprinted edition, Chaukhambha Prakashana, Varanashi 2010; 220. 4. Ibidem (4) Caraka Saṃhitā, Cikitsasthāna, Atisāracikitsitam Adhyāya,19/5; 548. 5. Ibidem (1), Aṣṭānga Hṛdaya, Nidānasthāna, Vātaśoṇitanidānam Adhyāya, 16/25-26; 537. 6. Vṛddha Vāgbhaṭṭa, Aṣṭāṁgasaṁgraha, Sūtrasthāna, Dravadravyavijñānīya Adhyāya, 6/17, edited by Dr. Shivprasad Sharma, Second edition, Chaukhamba Sanskrit Series Office, Varanashi 2008; 38. For Correspondence Bharat L. Bhadiyadra Email: dr.bharatbhadiyadra@gmail.com