Home » Trials » SLCTR/2018/041 » Progress Reports
Date Modified
2020-02-01
Period
12/months
Report Summary
Clinical trial is conducting smoothly according to the approved protocol since beginning up to now. Protocol was not changed after final approval and there were no any protocol violations or deviations. All the investigators are participating equally with the research work under the supervision of supervisor. No changes occurred with regard to funding. Security of the records are maintaining properly according with no access to any other personnel rather than investigators. Code has been given to each record sheet in which the identity of the patient cannot be traced. Up to now, total of 22 patients have been randomized in to the trial out of which 12 are cases and 10 are controls. There were no any dropouts up to now. Out of 12 cases 11 have completed the 10 week period of music therapy and 1 is still participating the therapy. Out of total 10 controls 8 have completed the observation of 10 week period and 1 is still being followed up. All the patients are participating the trial with much enthusiasm and there are no any adverse events reported up to now. Although the trial was planned to complete within one year duration, the required total cases and controls (30) are not yet completed due to lack of admissions and delayed patient turn over in the hospital. Six month and 1 year progress reports have been already submitted to Ethical Review Committee and hence the required sample size of 30 could not be completed within one year duration, request was made for the extension of Ethical Committee Approval following which the ethics approval for the study was extended for further one year period from 16.10.2019. Approval letter is attached here with. 3 more cases and 5 more controls are needed to complete the trial and we hope that we will cover the required number within next 6 months to complete the trial and proceed for data analysis.