Correspondence Address:
Pankaj B Shah
Department of Community Medicine, SRMC and RI, SRU, Chennai, Tamil Nadu
India

Full Text

Sir,

At the outset, I would like to congratulate Indian Journal of Dental Research and Prashant Gupta et al. [1] for a wonderful paper. The paper assesses therapeutic effect of levamisole in recurrent aphthous ulcers in a randomized control study. It should be randomized controlled trial (RCT) study rather. In the methodological section, it is described as the case-control study. There is no RCT as case-control study. Case-control study is an observational study while RCT is an interventional study or experimental study. The institutional ethics committee (IEC) approval is indicated only with group III and not with other groups. Does it mean that other groups were enrolled without IEC? If it is so, it is totally unethical. [2] As per Drug Controller General of India, it is mandatory that all clinical trials are registered with Clinical Trial Registry India (CTRI). [3] There is no mention of the same in the article. If it is not done, then investigators and IEC both have failed to follow one of the important Indian guidelines. Furthermore, it is decided by International Journal of Medical Editors that no clinical trial should be published without CTRI registration. [4] Article does not clearly indicate if informed consent is taken before starting the drug as it indicates that consent was taken before clinical examination and procedures. RCTs are analyzed as intention-to-treat analysis which is totally lacking in the article. Hence, it is must that enough care should be taken while planning the RCT.

References