A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of  Emblica officinalis  extract in patients with dyslipidemia

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Abstract

Background

Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla ( Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia.

Methods

A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500 mg) or a matching placebo capsule was administered twice daily for 12 weeks to the respective group of patients. The patients were followed up for 12 weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH).

Results

In 12 weeks, the major lipids such as total cholesterol (TC) ( p = 0.0003), triglyceride (TG) ( p = 0.0003), low density lipoprotein cholesterol (LDL-C) ( p = 0.0064) and very low density lipoprotein cholesterol (VLDL-C) ( p = 0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) ( p = 0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more ( p = 0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla ( p = 0.2942) or placebo groups ( p = 0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS > 100 mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study.

Conclusions

The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins.

Trial registration

Registered with Clinical Trials Registry- India at www.ctri.nic.in (Registration number: CTRI/2015/04/005682) on 8 April 2015 (retrospectively registered).

Electronic supplementary material

The online version of this article (10.1186/s12906-019-2430-y) contains supplementary material, which is available to authorized users.

Related collections

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Author and article information

Contributors

Haridas Upadya: dr.upadya123@gmail.com

S. Prabhu: svpm33@yahoo.com

Aravinda Prasad: draravindaprasad.sv@gmail.com

Deepa Subramanian: deepa@syncretic.in

Swati Gupta: +91-854-7746404 , swatigupta@aims.amrita.edu

Ajay Goel: 214-820-2603 , Ajay.Goel@BSWHealth.org

Journal

Journal ID (nlm-ta): BMC Complement Altern Med

Journal ID (iso-abbrev): BMC Complement Altern Med

Title: BMC Complementary and Alternative Medicine

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-6882

Publication date (Electronic): 22 January 2019

Publication date PMC-release: 22 January 2019

Publication date Collection: 2019

Volume: 19

Electronic Location Identifier: 27

Affiliations

[1 ]Aadhitya Adhikari Hospital, Contour Road, Gokulam, Mysore, 570002 India

[2 ]LifeCare Hospital, No.99, OM Complex, 20th Main, Gangothri Circle, BTM 1st Stage, Bangalore, 560029 India

[3 ]Sri Venkateshwara Hospital, No.86, Hosur Main Road, Madiwala, Bangalore, 560068 India

[4 ]Syncretic Clinical Research Services, No. 4, 5th cross, 11th Main Road, Vasanthnagar, Bangalore, 560052 India

[5 ]ISNI 0000 0000 9081 2061, GRID grid.411370.0, Amrita School of Pharmacy, Amrita Institute of Medical Sciences and Research Centre, , Amrita Vishwa Vidyapeetham, ; Kochi, 682041 India

[6 ]ISNI 0000 0001 2167 9807, GRID grid.411588.1, Center for Gastrointestinal Research, Center for Translational Genomics and Oncology, Baylor Scott & White Research Institute and Sammons Cancer Center, , Baylor University Medical Center, ; Dallas, Texas, 3410 Worth Street, Suite 610, Dallas, TX 75246 USA

Article

Publisher ID: 2430

DOI: 10.1186/s12906-019-2430-y

PMC ID: 6341673

PubMed ID: 30670010

SO-VID: 0c74a10d-2e7a-44dd-ab75-9905db4e98aa

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.