AN OPEN CLINICAL TRIAL OF SIDDHA FORMULARY DRUG SWASAKASA NEI IN THE MANAGEMENT OF SWASAKASAM (BRONCHIAL ASTHMA)

In this clinical trial, patients reporting at OPD 1 Maruthuvam, Ayothidoss Pandithar Hospital, NIS with the clinical symptoms of difficulty in breathing, Rhinitis, cough with or without expectoration, sleeplessness, wheezing, chest tightness were examined clinically for enrolling in the study based on the inclusion and exclusion criteria. Patient Information Sheet and Informed Consent Form was issued to the patients. The patients enrolled in this study and informed about the objective of the study, Trial drug, possible outcomes in their own language and terms understandable to them. After ascertaining the patient’s willingness, informed consent were obtained in the consent form. All these patients were registered in A-HMIS and unique registration card was issued which contains information regarding patients’ Registration number, Address, Phone number and Doctors phone number etc. It can help to report easily if any adverse reactions arise. Complete clinical history, complaints and duration, examination findings all was recorded in the prescribed case report form (CRF). Screening Form- I was filled up; Form II was used for recording the patient’s history, clinical examination of signs and symptoms.  Form III was used for recording laboratory investigations respectively. Patients were advised to take the trial drug with an appropriate dietary advice given in form VIII

On day 1 patient were advised to take oil bath with Chukku thylam or Peenisa thylam (required quantity)On day 2 the patient was advised to take purgative medication Agasthiyar kuzhambu â€“ 1 kundri (130 mg) with kadukkai kudineer at early morning in empty stomach.On day 3 patient is advised to take rest (without medication).From day 4 onwards the trial drug SWASAKASA NEI( 1.5- 3 ml) was administrated orally after food twice a day.The trial drug “**SWASAKASA NEIâ€**50ml was issued to the patient. The patients were asked to visit the OPD once in 7 days for clinical assessment. At each visit clinical assessment was recorded in the case report form(CRF) and the drug was issued.

**CONCLUSION:**In this study, trial drug showed significant improvement in all 30 patients. Therefore, this clinical trial purely indicates the trial drug is clinically effective in Bronchial asthma.The mean score of WBC, in before treatment was 8433.6 with standard deviation of 2217.5 and after treatment was 7814.2 with standard deviation of 2087.2.It was statistically significant (p = 0.002*) result with “t†value 3.4.The mean score of Eosinophil count,  before treatment was 6.4 with standard deviation of 3.8 and after treatment was 4.4 with standard deviation of 1.9. It was statistically significant (p <0.001**) result with “t†value 3.8.The mean score of ESR within 1 hr , before treatment was 17.1 with standard deviation of 12.6 and after treatment was 13.6 with standard deviation of 10.4. It was statistically significant (p <0.001**) result with “t†value 4.The mean score of Absolute Eosinophil count (AEC), before treatment was 580.7 with standard deviation of 412.3 and after treatment was 352.7 with standard deviation of 265.4. It was statistically significant (p <0.001**) result with “t†value 5.6.The mean score of Serum IgE level, before treatment was 1089.7 with standard deviation of 1156.3 and after treatment was 687.3 with standard deviation of 784.2. It was statistically significant (p <0.001**) result with “t†value 4.7.The mean score of PEFR, before treatment was 286.3 with standard deviation of 60.4 and after treatment was 345.3 with standard deviation of 80.8. It was statistically significant (p <0.001**) result with “t†value 7.2.Statistical analysis reveals the drug has more potential to reduce the elevated allergic and inflammatory mediators in blood. And, the Quality of life with decreased Peak expiratory flow rate was also markedly improved after treatment. There was no adverse reactions were reported during the course of this trial.The trial drugs are simple preparation with low cost and easily available plant materials. So, â€œSWASAKASA NEI†can be used in Bronchial asthma especially in Allergic types and Eosinophilia like conditions.