Registration
We registered the trial with clinical trial registry of India under the CTRI Number: CTRI/2017/05/008553 on 15/05/2017. The Institutional Ethics Committee of Datta Meghe Institute of Medical Sciences (Deemed to be University) approved the trial vide letter with Ref no: DMIMS (DU)/IEC/2017–18/6306 dated 27.03.2017.