Clinical evaluation of the effect of oral administration of Vātarākṣaca kulikai along with external ēraṇṭa tailam therapy in the management of “Cirakkampavātam”

“Sirakkamba vatham” – which is one among the vatham mentioned by the great Siddhar “Yugimuni”. The great siddhar mentions it one among the vatha disease that occur in the adults. But the symptoms that are mentioned for the Sirakkamba Vatham which is most commonly seen in the children age group, the symptoms which arises when they are in the child period. This dissertation has dealt with the Clinical evaluation of the Drug “Vatharakshasan Mathirai” and the External medicine “Eranda Thailam” for the management of the “Sirakkamba Vatham” in the child age group from 1 – 12 yrs. It has also explained about the preclinical aspects of the drugs and also the revies of the drug, and its qualitative and quantitative analysis. The clinical features of Sirakkamb Vatham can be correlated with Cerbral Palsy which shows the prevalence of 2 – 2.5 births/ 1000 live births. There are many research and development which is running in the modern aspects for to show improvements in the management and treatment aspects. The intension of this dissertation is to know the efficacy of the Drug “Vatharakshasan Mathirai” a herbomineral drug which is mainly used only during the chronic conditions of the patients. As Sirakkamba Vatham is one of the battling in treatment and management for the health professionals, the initiatives that are taken by the traditional medicine health professinals for the management can give some of the mild improvements to the child, which may be found better for their day to day activities. Based on the Literature – The classical literature in Siddha Medicine written by the Siddhar “Yugimuni” – “Yugivaidhya Chintamani” which totally tells us about 80 types of Vatha disease and one of which is the Sirakkamba Vatham. The clinical features mentioned in the literature which may be correlated with the Cerebral Palsy that seen in the Children age group. Based on the Drug – The Internal Drug Vatharakshasan Mathirai which is indicated for all types of Vatham and in Delirium conditions a herbomineral drug which is mentioned in Classical Siddha Literature “Agathiyar Vaidhya Rathina Churukkam” is chosen for the clinical trial in management for “Sirakkamba Vatham”. The External medicine “Eranda thailam” which is mentioned in the Siddha literatue “Sarbenthira Vaidhya Muraigal (vatha roga sikitchai)” is selected as an external therapy for the patients suffering from “Sirakkamba Vatham”. After the selection of the drugs they were reviewed properly, qualitative and quantitative analysis, pre – clinical experiments were done in the Wistars rat to study about its properties, toxicity and pharmacological activity. By the experiments done on the internal medicine it was known that the drug has a good pharmacological activity, there is mild toxicity seen in the animal experiments in all the dosage groups predicted only histopathologically. The hematological parameters does not show any alterations. The biochemical analysis of the drug tells the presence of Calcuim, Sulphate, Chloride, Ferrous iron, and Amino acid. The Qualitative analysis of the external drug – “Eranda thailam” shows the presence of Sulphate, Chloride, Ferrous iron, Starch, Tannic acid, unsaturated compound and Amino acid. The pharmacological activity performed was the Muscle relaxant activity in Wistar Rats showed a good results. The anti Microbial activity of the internal drug showed a moderate sensitive towards E. coli bacteria. Based on the Clinical Evaluation: Clinical evaluation was carried out only after the prior appearance in the IEC (Institutional Ethical Commitee). Subjects who were selected was purely based on the inclusion and exclusion criteria. 21 subjects were treated in this study. The laboratory investigations like CT, MRI, and routine blood test were only if the subject cooperated well and the no of days treated was more than 90 days and only some where unable to follow the treatment for more than 90 days. The prognostic criteria choosen for the treatment are as follows: AGE CRITERIA: Out of 21 patients, 9 were from the age group between 2 – 6 years and 12 were between the age group 7 – 12 years. SEX CRITERIA: Out of 21 patients, 10 were males and 11 were female children Socio Economic Status: Out of 21 pateints, 6 were from poor socio economic status, 14 were from middle socio economic status and 1 was from higher socio economic status. DIET CRITERIA: Out of 21 paients, 20 were following Non vegetarian diet and only one child was consuming Vegan diet. SEASONAL VARIATION: Out of 21 patients, 3 were admitted during the Kārkālam, 9 were admitted during Kūtirkālam, 6 were admitted during Muṉpaṉikkālam, 3 were during the period of Iḷavēṉilkālam. VATHAM DERANGEMENT: Out of 21 patients, 3 patients had derangement in Pirāṇaṉ, 20 had derangement in both ApāṉAṉ and ViyāṉAṉ, 19 had derangement in UtāṉAṉ , all the patient had derangement in CamāṉAṉ , 15 were in Nākaṉ, 5 were from Kūrmaṉ , 4 were from Kirukaraṉ , only 1 had derangement in Tēvatattaṉ PITHAM DERANGEMENT: Out of 21 patients 3 had derangement in AṉArpittam, all of them had derangemernt in Irañcakam Pittam, 20 had derangement in Cātakap Pittam, and only one had derangement in Ālōcaka Pittam KAPHAM DERANGEMENT: Out of 21 patients all of them had derangement in Avalampakam and Cantikam, and 3 of them had derangement in Kilētakam. UDAL THATHUKKAL: Out of 21 patients, all of them had derangement in their udar thathukkal and no affect in Cukkilam/ curoṉitam. ENVAGAI THERVU: Out of 21 patients all of them were having derangement in Naadi, and 19 were having derangement in Mozhi, Malam and Moothiram, 4 of them had derangement in Vizhi. GMFCS SCALE: Out of 21 patients, showed a mild reults in some were seen after the treatment, in Gross Motor Function Classification System (GMFCS) CFCS SCALE: Out of 21 patients, there was mild improvement seen after the treatment according to Communication Fuction Classification System (CFCS) MACS SCALE: Out of 21 patients, there were mild improvements seen in the MACS scale after the treatment. EDACS SCALE: Out of 21 patients, all were under Level 4 in which Eating and Drinking with significant limitations to safety. MAS SCALE: Out of 21 patients, most of the patient showed improvement from level 4 to level 3 after the treatment. Thus shows there is a mild improvement according to the Modified Ashworth Scale (MAS). Results after treatment: As the condition in Sirakkamba Vatham is like mostly the subjects are almost paralysed and even finding very hard for their day to day activities. Almost most of the cases presented during the period of study was spastic type. The treatment was based on the patient’s history and the prognosis that can be seen in the subjects were if the subjects who got their treatment for more than 90 days period showed mild to moderate results in their spasticity and drooling of saliva were relieved and in case the patient was presented with constipation they were relived from the symptom. But still the study if studied further in large no of samples in future it may give us a better understanding towards the treatment strategy for Sirakkamba Vatham. Resuts that were shown in the external therapy was the patient was relived from the spasticity and also the pain. The flexibility in the muscles showed a mild improvement. Overall, from this study performed it shows a milder improvement for the patient who were treated during the course. CONCLUSION: The study “Clinical Evaluation of Internal medicine “Vatharakshasan Mathirai” and the External medicine “Eranda thailam” towards the management of “Sirakkamba Vatham” which was approved by the Institutional Ethical Committee conducted by Government Siddha Medical College, Palayamkottai for a period of 18 months which treated around 21 patients for about more than 90 days which is properly registered under the CTRI(Clinical Trial Registry of India) showed a milder improvements in their symptoms like neck holding, Spasticity, Constipation, Seizures, Drooling of Saliva, Squint eyes, also too some extent it also showed a milder improvement in Emotional and behavioral related disorder and hearing difficulties. During this 90 days there were no improvements made in their speech, vision. So, in future if the treatment period is increased we may show some improvements in their speech. This Herbomineral drug method of treatment should be further studied to get more about its paharmacokinetics and pharmacodynamical actions in our body. The initiatives taken in traditional medicine for this type of severe disability disease may gave a better understanding towards the herbomineral drug towards this long time disease conditions and this may also be useful in future to start with the Integrative way of approaching the disease. This kind of study can also give a better understanding in treating the children age group with herbomineral drug without fear