Research Article
A Randomized, Triple-Blind, Placebo-Controlled, Add-On
Clinical Trial to Evaluate the Efficacy of Emblica officinalis in
Uncontrolled Hypertension
Samad Ghaffari,
1
Maryam Navabzadeh,
2
Mojtaba Ziaee,
3
Ali Ghobadi,
2
Roshanak Ghods,
2
and Fataneh Hashem-Dabaghian
2
1
Tabriz University of Medical Sciences, Tabriz, Iran
2
Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences,
Tehran, Iran
3
Medicinal Plants Research Center, Maragheh University of Medical Sciences, Maragheh, Iran
Correspondence should be addressed to Fataneh Hashem-Dabaghian; dabaghian.f@iums.ac.ir
Received 17 March 2020; Revised 11 July 2020; Accepted 23 September 2020; Published 7 October 2020
Academic Editor: Pratibha V. Nerurkar
Copyright © 2020 Samad Ghaffari et al. is is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
properly cited.
Introduction. Emblica officinalis (EO) has some cardiovascular effects, and there are some animal studies that show its anti-
hypertensive effect. is study was conducted to determine the effect of combination of EO with standard therapy on the systolic
blood pressure (SBP) and diastolic blood pressure (DBP) in patients with uncontrolled hypertension. Materials and Methods. is
was a randomized, triple-blind, placebo-controlled, 8-week study. Ninety-two patients with uncontrolled hypertension despite
taking hypotensive drugs were randomly assigned into two groups to take EO (500 mg/TDS after meal) or placebo in combination
with standard antihypertensive drugs. After 2, 4, 6, and 8 weeks of intervention, SBP and DBP and heart rate (HR) were measured.
Data were analyzed by SPSS software using repeated measures ANOVA. Results. Eighty-one patients (41 in the drug group and 40
in the placebo group) completed the study for 8 weeks and were analyzed. e mean ± standard deviation of age was 53.64 ± 10.01
years. SBP decreased as 15.6 ± 8.23% in the EO group and 6.3 ± 7.49% in the placebo group (P < 0.001). DBP decreased as
12.3 ± 7.87% and 3.88 ± 7.98%, respectively (P < 0.001). Time effect was not significant, but the group effect was significant
(F � 13.875, P � 0.001 for systolic BP and F � 18.948, P < 0.001 for diastolic BP). No side effects were reported during the study.
Conclusion. Eight-week combination therapy of EO with standard antihypertensive drugs significantly reduced the SBP and DBP
more than placebo in patients with uncontrolled hypertension.
1. Introduction
Hypertension is one of the important public health and
economic problems “worldwide”. e prevalence of hy-
pertension is high both in developing and developed
countries [1, 2]. It has been estimated that 60% of adults will
have hypertension by the year 2025 [3]. Based on the results
of a systematic review until 2012, the overall prevalence of
hypertension in Iran was about 22% [4]. Another systematic
review in 2017 reported the prevalence of hypertension in
Iran as about 17% [5].
Hypertension is an important predictor of premature
death and disability and plays a key role in the mortality and
morbidity from cardiovascular diseases and cerebrovascular
accidents [6].
In2010,highbloodpressurewasoneofthe5or6leading
risk factors for Global Burden of Disease (GBD) worldwide,
as assessed by DALYs [7].
e goal of the World Health Organization (WHO) is to
reduce the prevalence of hypertension to 25% [8]. Hyper-
tension is the most prevalent risk factor for cardiovascular
diseases and death globally [9]. Despite the availability of
Hindawi
Evidence-Based Complementary and Alternative Medicine
Volume 2020, Article ID 8592869, 7 pages
https://doi.org/10.1155/2020/8592869