A clinical evaluation of Pacchai Karpoora Mathirai for Kabasuram (Acute Bronchitis) in children

The Study on Kabasuram is done to explore the identity of the illness for the children & to review the Siddha Literature. The Literature evidence of both Siddha & modern were reviewed & recent studies on the individual drugs of the trial drug were collected. The drug which are mentioned in siddha literature for the management of Kabasuram were selected and the study is conducted after the proposal was screened by the screening committee of National Institute of Siddha. The clinical study has been approved by IEC of NIS, approved no: NIS/IEC/9/2014-15/22-26.08.2015. The trial registred in clinical trial registry of India with reg no: CTRI/2017/05/008457 The Authentication of ingredients of the trial drug was obtained from medicinal Botanist NIS Chennai and CRRI, Arumbakkam, Chennai. Purification of raw drugs and preparation of trail drug was done at Gunapadam Laboratory, Department of Gunapadam, NIS, Chennai. Bio Chemical Analysis of trial drug was done in Biochemistry Laboratory, Department of Biochemistry, NIS Chennai. Physio chemical analysis was done in CRRI, Arumbakkam, Chennai. Patients attending the Kuzhandhai maruthuvam OPD, AyothidossPandithar hospital of NIS having the compliance of Kabasuram, diagnosed clinically and the patients were observed. Clinical symptoms of kabasuram emphasis with the symptoms of acute bronchitis like Fever, Cough with or without expectoration, constipation, poor appetite and myalgia. Clinical diagnosis of kabasuram was done on the basis of clinical features described in Balavagadam text. Diagnosis had been made out based on the specially prepared proforma, including all clinical signs and symptoms of the disease, in which detailed history had been taken. According to the Literature evidence the Symptoms of Kabasuram may be correlated with acute bronchitis. The medicine chosen for this clinical trial is Pacchai Karpoora Mathirai internally once a day. All the patients were kept under diet control during the treatment. The clinical efficacy of the drug was analyzed statistically on all the symptoms based on the assessment criteria. Kabasuram explained in siddha paediatric text balavagadam having the symptoms of fever, dry or productive cough, breathing difficulty, constipation, Running nose, Malaise which are in the close familiarity with the clinical manifestation of acute bronchitis. Among 40 cases, 40(100%) cases had fever, 37(92.5%) cases had cough, 25(62.5%) cases had running nose, 15(37.5%) cases had constipation, 39(97.5%) cases had malaise, 19(47.5%) cases had breathing difficulty. At the end of the treatment amongst 40 cases 100% of cases got relief from fever,amongst 37 cases, 54% of cases got relief from cough, amongst 19 cases,68.4% of case got relief from breathing difficulty,amongst 15 cases, 93.3% of cases got relief from constipation, amongst 25 cases 64% of cases got relief from running nose, amongst 39 cases, 35, 8% of cases got relief from malaise. From the above results it is evident that signs and symptoms explained in siddha and modern literatures are mostly reflected and in coherence with in the paediatric population. The Kabasuram score of Pacchai Karpoora Mathirai, before and after treatment were 4.2750 ± 2.1362 and 0.9750 ± 1.3865 respectively which is statistically significant.(t – value 9.253, p < 0.00). The reduction of Kabasuram score from the start of treatment is 55 % at the end of the treatment. About 55% gives good result,37.5% of children gives moderate result & 7.5% cases were poor result. The observation made during the clinical study showed that the trail drug, Pacchai Karpoora Mathirai was clinically effective on Kabasuram (Acute bronchitis). CONCLUSION: The present study indicates the purity and stability of the test drug Pacchai Karpoora Mathirai. The test drug in-vitro Anti-Inflammatory Activity, from the result of the study it was concluded that the test drug Pacchai Karpoora Mathirai possess promising anti-inflammatory property in protein denaturation assay. In the present study the trail drug Pacchai Karpoora Mathirai is treated to the children of age group 8-12 yrs. All the forty patients of Kabasuram were treated with Pacchai Karpoora Mathirai (65mg) internally once a day. The ingredients of Pacchai Karpoora Mathirai are easily available and very much affordable to all people. The trial medicine has many properties to control the signs and symptoms of Kabasuram. During the course of treatment, no adverse interactions were observed. Clinical results were found to be significantly good improvement in 55% of cases, moderately in 37.5 % of cases. Because of the encouraging results clinically, the study may be carried over to further researches, pharmacological study, toxicity, and it may motivate the upcoming generation to manage the disease Kabasuram through the Siddha medicine and also this study throw a new glitters to Siddha scientific community