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Article History

Received: 26 April 2018

Accepted: 9 October 2018

First Online: 22 October 2018

Ethics approval and consent to participate

: The preclinical study protocol was approved by the Institutional Animal Ethics Committee. The ethics approval for the clinical trial was obtained from the ethical committee of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), Eluru, India, a not for profit organization. All participants signed the Institutional Review Board approved informed consent before the commencement of the study.

: Not applicable.

: The research team of the sponsor designed the clinical study protocol. The entire study operation and the data analyses were carried out independently by the Suraksha Health Village (SHV), Vijayawada, India and B10 Analytics Pvt. Ltd. Thiruvananthapuram, India, respectively. SHV is an independent health science center, who independently operated the clinical trial. MRK is an Ayurvedic practitioner and is an employee of SHV. He has no financial interest in conducting the study. KVA, PKJ, TG, and KS are employees of Laila Nutraceuticals R & D Center, India. Laila Nutraceuticals has filed a patent application on GMCT composition (PCT/IN/2014/000004).

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