Study design This study was a randomised parallel group clinical trial to study the effect of Anu Tail Nasya on healthy volunteers with the help of normal nasal bacterial micro-flora. There were two groups one intervention group i.e., Group A receiving Anu Tail Nasya therapy for seven days and second group i.e., Group B without any intervention. Hypothesis The study was conducted to observe the effect of Anu tail Nasya on nasal bacterial flora whether Anu tail Nasya will help to maintain commensal bacterial flora and also it will reduce pathogenic bacteria flora. Sampling Technique The volunteers were selected irrespective of their sex, religion, and occupation etc., The Simple random sampling method(lottery method) was adopted for grouping. Design Parallel-Group Randomized clinical trial The study had received prior approval from the Institutional ethics committee. (Ref. No. MAM/SS Ayu/711 Date 29/12/2010) Sample size After screening, 100 volunteers filter through following criteria Methods:- 1. Screening of volunteer: -Volunteers were screened with the help of screening form. The screening proforma consist of inclusion and exclusion criteria. The Health status of the volunteer was decided with the help of Health status form. It includes the Charakokta and Kashyapokta Swastha Lakshana. Those fulfilled the above criteria was investigated for complete blood count. The screened volunteers having complete Blood count within normal range were enrolled for further study after signing informed consent. 2. Ethical consideration and informed Consent:- The eligible volunteers were fully informed about the study in their own first language. The researcher freely obtained written informed consent of the volunteer for their participation in the study. The consent form was fully explained to the Volunteer. The Volunteer was given ample opportunity to ask questions and be assured that non-participation in the study would not compromise any right and, once enrolled the volunteer could withdraw consent or to be discontinued from the study at any point. § Enrollment day was considered as ’ day 0’ and baseline information were collected. After the enrollment, each volunteer was given a separate ID form to hide their identity. 3. Enrolled volunteers were randomly allocated into two groups i.e.Group A and Group B with the help of lottery method. 4. Grouping of Volunteers Group A- Intervention group § Number of volunteers- 50 § Anu Tail Nasya therapy for seven days § Route of Dravya Administration-Nasa § Dose of Nasya- 8 drops in each nostril followed by Gandusha § Nasal swab was obtained on day 0 (baseline), 10th day and 20th day from the day of enrollment. Group B-Control group § Number of volunteers- 50 § No intervention § Nasal swab was obtained on day 0 (baseline), 10th day and 20th day from the day of enrolment. Scheduled follow-up § 0 day – Enrolment day § 10th Day - 1st follow up § 20th Day - 2nd follow up Culture Technique:- The culture technique was performed according to technique mentioned in Mackie (1). Culture Report Result The result of microbial study was compiled under three groups i.e. I) Major component of normal nasal flora, II) Common sinus pathogens and III) other bacteria. The group of major component of normal flora includes α-hemolytic streptococci, Coagulase-negative staphylococci, Coagulase positive staphylococci. II) Common sinus pathogen is β- hemolytic streptococci. III) Other bacteria include Bacillus subtilis, Enterobacteriaceae species (It includes E. coli, K. pneumoniae and P. mirabilis), Pseudomonas and Nonhemolytic streptococci. Unscheduled follow-up Volunteers who came at study centre other than their actual scheduled follow-up for any complaints considered as unscheduled follow- up. Serious adverse events (SAE) If any Serious Adverse Events happened then, it will be recorded and immediately reported to the Ethics Committee. Drop out criteria:- 1. Voluntary withdrawal of consent (VW) – Volunteer not willing to continue his participation in the study and expressed their desire to withdraw consent at any time in the study period. 2. Moved out of study area (MO) – If the Volunteer expressed his desire to discontinue the study and was not willing to follow up because he shifted from his current residing place and moved out of the study area beyond 50kms from the study site. 3. Lost to follow-up (LTF) - Any Volunteer who did not turn up at the study centre on schedule visit and could not be traced on home visit/cell phone contact was considered as lost to follow-up. 4. If any serious adverse events (SAE) |