A A M J Anveshana Ayurveda Medical Journal

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1 A A M J Anveshana Ayurveda Medical Journal ISSN: Research Article A Comparative Clinical study in the management of Pariṇāma Śūla by an Ayurvedic Classical formulation C. Thyagaraja 1 Mahesh D Desai 2 Srinivas K. Bannigol 3 Sunil Roy 4 A b s t r a c t Peptic Ulcer Disease is on the rise due to the faulty diet and habits. In India particularly south India is quite high, Recent studies suggests approximately 10% of adults at some times of their lives get affected by peptic ulcer. The disease Pariṇāma Śūla can be compared to peptic ulcer as explained in modern medical science. The cardinal feature of Pariṇāma Śūla is pain during digestion of food which torments the person at every meal time and is a source of constant discomfort. In the present study two formulations namely Yavakṣāra yukta Eranda dvādaśa kvātha and Khanda kūṣmānḍa avaleha are taken to find their efficacy in Pariṇāma śūla (Peptic ulcer) and to compare the efficacy of these formulations. The present clinical study comprises of 30 patients. They were divided into two groups as Group-A and Group-B each having 15 patients. The group-a patients were given Yavakṣāra Yukta Eranda Dvādaśa Kvātha and Group-B patients were given Khanda Kūṣmānḍa Avaleha. For both the groups duration of the treatment was 3 months. Both Group patients were advised to undergo upper GI endoscopy before and after treatment. Both Yavakṣāra Yukta Eranda Dvādaśa Kvātha and Khanda Kūṣmānḍa Avaleha shown Statistically Highly Significant result in parameters Śūla(Abdominal Pain) and Hrid Dāha(Heart Burn). Comparative analysis of these groups showed that both the trial drugs are equally effective in the management of Pariṇāma Śūla (Peptic ulcer). Key words: Peptic ulcer; Pariṇāma Śūla; Upper G.I Endoscopy; Yavakṣāra Yukta Eranda Dvādaśa Kvātha; Khanda Kūṣmānḍa Avaleha. 1 & 2 Associate Professor, 3 Professor & Head, 4 PG Scholar, Dept. of PG studies in Shalya Tantra, Ayurveda Mahavidyalaya, Hubli CORRESPONDING AUTHOR Dr. C. Thyagaraja Associate Professor Dept. of PG studies in Shalya Tantra, Ayurveda Mahavidyalaya, Hubli, Karnataka., (India). drctraja@gmail.com ue1/aamj_1165_1170.pdf AAMJ / Vol. 3 / Issue 1 / January February 2017

2 INTRODUCTION The Traya Upasthambha (Three pillars of life) i.e. Āhāra, Nidra and Brahmacharya [i]. These three are responsible for healthy and longevity of life. Amongst these three prime importance has been given to Āhāra. Various rules are mentioned under the heading Āhāra vidhi. Disorders related to the digestive system are on the rise due to the faulty diet and habits. One such condition is Peptic ulcer. It is also known as ulcus pepticum. Peptic ulcer disease is an ulcer (mucosal erosions) of an area of the gastrointestinal tract that is usually acidic and thus extremely painful. The available information supports the central role of H.pylori and a necessary role of acid and pepsin. As much as 80% of ulcers are associated with Helicobacter pylori, a spiral-shaped bacterium, that lives in the acidic environment of the stomach. Ulcers can also be caused or worsened by drugs such as aspirin, other NSAIDs and glucocorticoids. Since Stress forms the most important single feature in causing peptic ulcer and today s modern life is full of stress and strain, hence this condition is on the increase. Peptic ulcer is a worldwide problem and its prevalence in India is quite high, Recent studies suggests approximately 10% of adults at some times of their lives get affected by peptic ulcer [ii]. The disease Pariṇāma Śūla can be compared to peptic ulcer Disease as explained in modern medical science. Pariṇāma Śūla is also a disease of Annavaha srotas. Considering the gravity of the condition, increasing incidence of the disease and non-availability of ideal treatment the present study is under taken. In the present study two formulations namely Yavakṣāra yukta Eranda dvādaśa kvātha [iii] and Khanda kūṣmānḍa avaleha [iv] are taken to find their efficacy in Pariṇāma Śūla (Peptic ulcer) and an attempt also has been made to compare the efficacy of these formulations. The patients suffering from Pariṇāma Śūla(Peptic ulcer) who fulfills the criteria of selection of the present study were selected. The patients were subjected for detail clinical examination and investigations as per the specially designed proforma. The present clinical study comprises of 30 patients. They were divided into two groups as Group-A and Group-B each having 15 patients. The group-a patients were given Yavakṣāra Yukta Eranda Dvādaśa Kvātha and Group-B patients were given Khanda Kūṣmānḍa Avaleha. Both Group patients were advised to undergo upper GI endoscopy before and after treatment. MATERIALS & METHODS The present study aims at analyzing the therapeutic efficacy of Yavakṣāra yukta Eranda dvādaśa kvātha and Khanda kūṣmānḍa avaleha in the management of Pariṇāma Śūla. Materials: 1. Yavakṣāra yukta Eranda dvādaśa kvātha - Eranda Phala, Eranda mula, Gokshura, Shaliparni, Prushni Parni, Brahati, Kantakari, SringaLavana, Sahadevi, Mashaparni, Mudgaparni and Iksuraka are the Ingredients. The Eranda dvādaśa kvātha was prepared as per the textual guidelines of kvātha kalpana. To this Yava kṣāra 125 mg has to be mixed and consumed. 2. Khanda kūṣmānḍa avaleha: Kūṣmānḍa 100 pala, Godugha 100 pala, Āmalaki 8 pala, Sita 8 pala, Ghurta 2 pala are the Ingredients. Eranda dvādaśa kvātha, Yava Kṣāra and Khanda kūṣmānḍa avaleha was prepared in Dept. of Rasa Shastra and Bhaisajya kalpana, Ayurveda Mahavidyalaya, Hubli. Source of Data: Patients attending the OPD and IPD of Ayurveda Mahavidyalaya Hospital, Hubli. Method of Collection of Data: Patients attending the Shalya Tantra OPD and IPD of Ayurveda Mahavidyalaya, Hubli, diagnosed as Pariṇāma śūla (peptic ulcer) and fulfilling the inclusion criteria were selected. Patients were registered and recorded as per the specially designed clinical proforma. Inclusion Criteria: Patients with clinical features of Pariṇāma śūla (Peptic ulcer). Presence of ulcer diagnosed by upper gastrointestinal endoscopy were selected. Patients of both sexes between 20 to 60 year aged were included in the study. Exclusion Criteria: Patients with features of malignant ulcer were excluded. Patients with acute features and with complication were excluded. Patients associated with uncontrolled systemic diseases were excluded. AAMJ / Vol. 3 / Issue 1 / January February

3 Parameters of study: Following subjective and objective parameters were considered for the study. Subjective: 1. Udara Śūla (Abdominal Pain) 2. Hṛllāsa (Nausea) 3. Chardi (vomiting) 4. Rakta chardi (Haematemesis) 5. Hrid dāha(heart burn). All the patients were examined once in 15 days during the treatment. The Improvement provided by the therapy was assessed on the basis of relief in the above mentioned signs and symptoms of the disease Pariṇāma Śūla. Objective: Objective parameters include 1. Malena 2. Endoscopic evidence of ulcer Investigations: Upper G.I Endoscopy Blood Blood group and Rh type Hb % RBS Stool Occult blood Study design: study. Present study is a comparative clinical Sample size: Minimum of 30 patients were selected randomly and categorized into two Groups as Group- A & Group B. RESULTS Effect of therapies on Udara Śūla (Epigastric Pain): Effect of therapies on Udara Śūla (Epigastric Pain) in Group A and Group B: The mean before treatment was 1.8 which reduced to 0.4 after the treatment. The total effect of therapy provided statistically highly significant (p<0.001) result with t value of in Group A. The mean before treatment was 1.67 which reduced to 0.6 after the treatment. The total effect of therapy provided statistically highly significant (p<0.001) result with t value of in Group B. Effect of therapies on Hṛllāsa (Nausea): Effect of therapies on Hṛllāsa(Nausea) in Group A and Group B : In Group A, The mean before treatment was which reduced to after the treatment. The total effect of therapy provided statistically significant (p<0.01) result with t value of In Group B, The mean before treatment was which was reduced to after the treatment. The total effect of therapy provided statistically significant (p<0.01) result with t value of Effect of therapies on Vami (Vomitting): Effect of therapies on Vami (Vomitting) in Group A and Group B: In Group A, The mean before treatment was which were reduced to after the treatment. The total effect of therapy provided statistically not significant (p>0.05) result with t value of In Group B, the mean before treatment was which were reduced to after the treatment. The total effect of therapy provided statistically significant (p<0.01) result with t value of Effect of therapies on Hrit Dāha (Heart Burn): Effect of therapies on Hrit Dāha (Heart Burn) in Group A and Group B: In Group A, The mean before treatment was 1.4 which reduced to 0.6 after the treatment. The total effect of therapy provided statistically highly significant (p<0.001) result with t value of In Group B, The mean before treatment was 1.4 which reduced to 0.4 after the treatment. The total effect of therapy provided statistically highly significant (p<0.001) result with t value of Effect of therapies on Melena: Effect of therapies on Melena in Group A and Group B: In Group A, The mean before treatment was 0.33 which reduced to 0.2 after the treatment. The total effect of therapy provided non-significant (p>0.05) result with t value of In Group B, The mean before treatment was which reduced to after the treatment. The total effect of therapy provided statistically non-significant (p>0.05) result with t value of Comparative efficacy of the therapies in Group A and Group B: The mean of Udara Śūla in Group A was 1.4, SD is 0.83and SE is In Group B, the mean of Udara Śūla was 1.07, SD is 0.8 and SE is 0.2. The comparative AAMJ / Vol. 3 / Issue 1 / January February

4 efficacy of Group A with Group B showed statistically not significant (p>0.05) result with t value of The mean of Hṛllāsa in Group A was 0.4, SD is 0.50 and SE is In Group B, the mean of Hṛllāsa was 0.73, SD is 0.8 and SE is The comparative efficacy of Group A with Group B showed statistically not significant (p>0.05) result with t value of The mean of Vami in Group A was 0.2, SD is 0.41 and SE is In Group B, the mean of Vami was 0.33, SD is 0.48 and SE is The comparative efficacy of Group A with Group B showed statistically not significant (p>0.05) result with t value of The mean of Hrit Dāha in Group A was 0.8, SD is 0.67 and SE is In Group B, the mean of Hrit Dāha was 1, SD is 0.65 and SE is The comparative efficacy of Group A with Group B showed not statistically significant (p>0.01) result with t value of The mean of Melena in Group A was 0.13, SD is 0.35 and SE is In Group B, the mean of Melena was 0.2, SD is 0.41 and SE is The comparative efficacy of Group A with Group B showed statistically not significant (p>0.10) result with t value of Effect of Therapy on different parameter in Group A (In percentage): Effect of therapy on different parameters in group A: A maximum percentage i.e % relief was observed in Parameter Udara Śūla, % relief was observed in Hrit Dāha, % relief was observed in Hṛllāsa, 40 reliefs was observed in Melena and 37.5 % relief was observed in Vamita. Effect of Therapy on different parameters in Group B (In percentage): Effect of Therapy on different parameters in Group B: A maximum percentage i.e.75% relief was Observed in Parameter Melena, % relief was observed in Parameters Vami and Hrit Dāha, % relief was observed in Hṛllāsa, 64 % relief was observed in Udara Śūla. Overall effect of therapy: The overall effect of treatment in Group A was 59.43% and in Group B was 68.5%. In Group A, 6 subjects (40 %) the ulcers are healed after the treatment and in Group B 7 subjects (46.67 %) the ulcers are healed after the treatment. DISCUSSION Discussion on Conceptual study: The fast paced stressful lifestyle coupled with inappropriate dietary habits have made man susceptible to a variety of disorders. Pariṇāma śūla, one such disorder, was selected for the present study. The nidāna for Pariṇāma śūla are not mentioned in any of the texts. Sāmānya śūla nidāna applies in the case of Pariṇāma śūla too. In addition to this, as Pariṇāma śūla is a sannipātaja vyādhi, the viśiṣṭa śūla nidāna pertaining to the tridoṣa were also included. This vyādhi being an Agnidustijanya vikāra and an Annavaha srotovyādhi, the Annavaha Sroto dusti nidāna also apply here. The Rūpa told in pariṇāma śūla Śaṣṭikaśālivrihinamodanena vivardhate can also be regarded as nidāna. This is evident from the fact that Duodenal ulcer is known to be more common in the rice-eating areas of India than in the wheat-eating areas. This difference is attributed to the increased mastication required by the unrefined wheat diet, which is associated with an increase in saliva, lower stomach acidity and reduced bile output. So it is not only what we eat but even more how we eat it that is relevant in peptic ulcer disease. In recent days the use of NSAID s, Aspirin, Steroid Drugs also becoming a major nidāna for Pariṇāma Śūla. Amlapitta is also a nidāna for Pariṇāma Śūla. Contemporary science also says Gastritis and Peptic ulcer are known to occur secondary to each other. Psychological stress has a major role to play in causing gastritis and ulcers. This acts by an intense vagal stimulation that initiates a cholinergic activity. It stimulates gastrin secretion, reduces parietal cell threshold level for response to gastrin, stimulates histamine secretion that in turn triggers acid secretion and also stimulates pepsin secretion. H-pylori infection is implicated with the causation of Peptic ulcers. H-pylori infection is present in virtually all patients with duodenal ulcers and about 70% of those with gastric ulcers. But only 10-20% of individuals worldwide infected with H.pylori actually develop peptic ulcers. Other events that may act alone or in connection with H.pylori to promote peptic ulceration include dietary factors, genetic factors, psychological factors etc. In Ayurveda also reference about the presence of krimi(antrada,udarada etc) in Āmāśaya is there. Although none of the ayurvedic classics have described the involvement of krimi in pariṇāma śūla. Discussion on Lakṣaṇa: All the patients gave a history of Udara śūla. The site of pain however varied with majority of subjects explained pain in stanāntara (epigastric area) and some felt pain AAMJ / Vol. 3 / Issue 1 / January February

5 in jaṭara pārśva (rt. hypochondrium). These sites also correlate with those site of pain mentioned for Gastric and Duodenal ulcer in modern medicine. Hṛllāsa was observed in 50% of subjects and Chardi in 36.67% which shows the involvement of utkleshita Kapha and pitta doṣa % subjects given history of Hrid Dāha which shows the major role of Pitta doṣa. Malena: 9 subjects (30%) had presence of occult blood. This proves the fact that 65% of Duodenal ulcer cases will have Malena and it is uncommon in Gastric ulcer. Endoscopic findings: Endoscopic findings revealed Duodenal Ulcer in 22 subjects (73.33%), 8 subjects (26.67%) had gastric ulcers. This shows Duodenal ulcer is more common than Gastric ulcer. Discussion on Results: Effect on Udara Śūla (Abdominal pain): % relief was found on this symptom in group A. While in group B it was 64 %. Both the drugs have provided highly significant effect on this symptom. In Group A where Yavakṣāra Yukta Eranda Dvādaśa Kvātha is used shown better results eventhough Statistically not significant when compared with Group B.This is due to the Śūlāhāra and Ama pachana property of drugs in Eranda Dvādaśa kvātha. Effect on Hṛllāsa (Nausea): % relief was found on this symptom in group A. While in group B it was %. Both the groups given statistically significant result. Effect on vami (Vomiting): 37.5 % relief was found on this symptom in group A. In group B % relief was seen. In Group A statistically not significant result came this may be due to the non-palatable nature of the kashaya which is given in Group A. Effect on Hrid Dāha (Heart Burn): % relief was found on this symptom in group A. In group B % relief was seen. The better result in Group B is shows the Pittāhāra nature of Khanda kūṣmānḍa Avaleha when compared with Yavakṣāra Yukta Eranda Dvādaśa Kvātha. Effect of Malena: The relief on this symptom was 40% in group A and 75% in group B patients. Even though Group B got 75% relief it was statistically not significant due to reason that only 9 subjects had this complaint. Rakta srāva from vraṇa indicates severe morbidity of pitta and rakta. Khanda kūṣmānḍa owing to its madhura rasa has acted as pitta śāmaka and vraṇa ropaka. Discussion on overall assessment of therapy: In group A: In the present study on the subjects of Group A (Yavakṣāra Yukta Eranda Dvādaśa Kvātha) got mild relief at the end of duration of treatment. In parameters Udara śūla (77.78 %) marked relief was seen. In Hrid dāha (57.14%) moderate relief and in parameters Hṛllāsa(46.15 %), Vami (37.5%), Melena(40%) mild relief was seen. In group B: In the present study on the subjects of Group B (Khanda Kūṣmānḍa Avaleha) got moderate relief at the end of duration of treatment in all the parameters Udara śūla (64 %) Hṛllāsa (68.75 %), Vami(71.42%) Hrid dāha(71.42 %) Melena (75 %). The overall effect of treatment in Group A was 59.43% and in Group B was 68.5%. The comparative study between Group A and Group B was Statistically not Significant which shows that both the medicines are equally effective in management of Pariṇāma śūla. CONCLUSION After thorough discussion on various observations in the present Comparative clinical study following conclusions were drawn. From this study it can be concluded that noncompliance of code of healthy diet selection and eating plays a major role in causation of this disease. Vata Pradhāna Tridoṣas, Agnimāndhya, Sangam and Āvaraṇam plays role in pathogenesis. Pariṇāma Śūla is mentioned as Mahāgada due to the Chronic nature of the disease. Pariṇāma Śūla and Peptic ulcer disorder have Striking Similarity. Endoscopy plays a significant role in making precise Diagnosis of this condition. AAMJ / Vol. 3 / Issue 1 / January February

6 The incidence of Pariṇāma śūla (Peptic ulcer) is more in Persons having habits of Smoking, excessive tea/coffee intake and in persons with Mental stress. Both the trial drugs used in this study possessed Agnidipana, Āmapācana, Tridoṣaśamana, śūlapraśamana, Vraṇaropana and Rasāyana property which can effectively break the samprāpti of Pariṇāma Śūla. Both Yavakṣāra Yukta Eranda Dvādaśa Kvātha and Khanda Kūṣmānḍa Avaleha shown Statistically Highly Significant result in parameters Śūla and Hrid Dāha. Both Yavakṣāra Yukta Eranda Dvādaśa Kvātha and Khanda Kūṣmānḍa Avaleha are equally effective in the management of Pariṇāma Śūla. REFERENCES i. Agnivesha, Charaka Samhita, Chakrapani, 48 th edition reprint 2004, edited by Vaidya Yadavaji Trikamaji, Choukambha Publication. Ca. Su. 11/35 ii. Dr. Fauci's and Dr. Longo's, Harrison's Principles of Internal Medicine,17 th edition, The McGraw-Hill Companies, Chapter 287,2008. iii. Sushrutha, Sushrutha Samhitha, Dalhana commentary, edited by Vaidya Yadavaji Trikamji Acharya, Chaukhambha Sanskrit Sansthan. Su.U 42/ iv. Bhavamishra, Bhavaprakasha, Hindi commentary by Dr K.C.Chunekar, reprint edition, edited by Dr G.C Pandey, Chaukhambha Brahati Academy. Bha.Pra Madhyama 10/20,21 Source of Support: Nil. Conflict of Interest: None declared How to cite this article: Kamath Nagaraj: Thyagaraja et.al,. : A Comparative Clinical study in the management of Pariṇāma Śūla by an Ayurvedic Classical formulation. AAMJ 2017; 1: ΛΛΛΛ ΛΛΛΛ AAMJ / Vol. 3 / Issue 1 / January February