A Study on Patients Drop-Out in Unani Pharmacopeial Validation of An Anti-obesity Drug

Abstract

Background: In the clinical research human subject is never in control of researcher, so the rate of dropout in clinical studies is always a major concern. In herbal clinical research the high rate of dropout is always foremost distress for researcher, prolongs the study duration and adds extra financial burden to the project.

Objective of the study: The objective of this study is to find out the possible reasons of dropout in a validation programme.

Materials and methods: All human subjects were informed in advance about the test drug, dosage form, time of administration, number of follow-up and laboratory investigations. The statements/ reasons of leaving of enrolled subjects in validation study on anti-obesity drug Jawarish Bisbasa were recorded in the case record form. At the end of the study all statements were analyzed.

Results: Total 49 patients were dropouts from the study due to various reasons e.g. indiscipline, social injustice, not effective and bad taste of drug, conception, domestic work etc.

Conclusion: Collectively, dropout rates are higher among middle-income group followed by lower middle-income group. The minimum dropout was observed among the socio-economical weak section. As per the occupation house makers are more dropout in comparison to other groups and on other hand, taste, palatability and slow action of formulation are also among them. It is an attempt to understand and explain the direction for future trial design.