Issues to be addressed for a randomized controlled trial

Pankaj B Shah

doi:10.4103/0970-9290.156829

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LETTER TO EDITOR

Year : 2015 | Volume : 26 | Issue : 1 | Page : 108-109

Issues to be addressed for a randomized controlled trial

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

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Date of Web Publication

11-May-2015

How to cite this article:
Shah PB. Issues to be addressed for a randomized controlled trial. Indian J Dent Res 2015;26:108-9

How to cite this URL:
Shah PB. Issues to be addressed for a randomized controlled trial. Indian J Dent Res [serial online] 2015 [cited 2023 Jun 9];26:108-9. Available from: https://www.ijdr.in/text.asp?2015/26/1/108/156829

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

1.	Gupta P, Ashok L, Naik SR. Assessment of serum interleukin-8 as a sensitive serological marker in monitoring the therapeutic effect of levamisole in recurrent aphthous ulcers: A randomized control study. Indian J Dent Res 2014;25:284-9. [PUBMED]
2.	ICMR.nic.in. New Delhi: Indian Council Medical Research. Available from: http://www.icmr.nic.in/ethical_guidelines.pdf. [Last updated on 2006 Oct 01; Last cited on 2014 Aug 07].
3.	CTRI.nic.in. New Delhi: Clinical Trial Registry-India, Indian Council Medical Research. Available from: http://www.ctri.nic.in/Clinicaltrials/login.php. [Last updated on 2011 Jul 15; Last cited on 2014 Aug o7].
4.	CTRI.nic.in. New Delhi: Clinical Trial Registry-India, Indian Council Medical Research. Available from: http://www.ctri.nic.in/Clinicaltrials/cont1.php. [Last updated on 2011 Jul 15; Last cited on cited 2014 Aug 07].