Clinical studies / Clinical justification:
The herb Arjuna is well supported with research papers published all over the
world in renowned medical research journals of recent times. Summary of some of
the research papers is given below to support its inclusion in NEEROGA
Capsules.
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1) Int J Cardiol. 1995 May;49(3):191-9.
Salutary effect of Terminalia Arjuna in patients with severe refractory heart
failure.
Bharani A, Ganguly A, Bhargava KD.
Department of Medicine, M.G.M. Medical College, Indore, India.
Twelve patients with refractory chronic congestive heart failure
(Class IV NYHA), related to idiopathic dilated cardiomyopathy (10 patients);
previous myocardial infarction (one patient) and peripartum cardiomyopathy (one
patient), received Terminalia Arjuna, an Indian medicinal plant, as bark
extract (500 mg 8-hourly) or matching placebo for 2 weeks each, separated by 2
weeks washout period, in a double blind cross over design as an adjuvent to
maximally tolerable conventional therapy (Phase I). The clinical, laboratory
and echocardiographic evaluation was carried out at baseline and at the end of
Terminalia Arjuna and placebo therapy and results were compared. Terminalia
Arjuna, compared to placebo, was associated with improvement in symptoms and
signs of heart failure, improvement in NYHA Class (Class III vs. Class IV),
decrease in echo-left ventricular enddiastolic (125.28 +/- 27.91 vs. 134.56 +/-
29.71 ml/m2; P < 0.005) and endsystolic volume (81.06 +/- 24.60 vs. 94.10
+/- 26.42 ml/m2; P < 0.005) indices, increase in left ventricular stroke
volume index (44.21 +/- 11.92 vs. 40.45 +/- 11.56 ml/m2; P < 0.05) and
increase in left ventricular ejection fractions (35.33 +/- 7.85 vs. 30.24 +/-
7.13%; P < 0.005). On long term evaluation in an open design (Phase II),
wherein Phase I participants continued Terminalia Arjuna in fixed dosage (500
mg 8-hourly) in addition to flexible diuretic, vasodilator and digitalis dosage
for 20-28 months (mean 24 months) on outpatient basis, patients showed
continued improvement in symptoms, signs, effort tolerance and NYHA Class, with
improvement in quality of life
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2) Indian Heart J. 1997 Sep-Oct; 49(5):507-10.
Beneficial effects of Terminalia arjuna in coronary artery disease.
Dwivedi S, Jauhari R.
Department of Medicine, University College of Medical Sciences, Delhi.
Effect of Terminalia arjuna on angina pectoris, congestive heart
failure and left ventricular mass was studied in patients of myocardial
infarction with angina and/or ischaemic cardiomyopathy. Bark stem powder of T.
arjuna, 500 mg 8 hourly was administered to 10 patients of postmyocardial
infarction angina and two patients of ischaemic cardiomyopathy, in a dose of
500 mg 8 hourly postoperatively, for a period of three months (Group A). These
patients were also on conventional treatment comprising of nitrates, aspirin
and/or calcium channel blockers. Twelve age-, sex-, body mass index- and
ECG-matched patients of postmyocardial infarction angina receiving only
conventional treatment served as controls (Group B). Significant reduction in
anginal frequency was noted in both groups (3.5 +/- 1.98 to 1.08 + 1.08 per day
vs 3.10 + 0.72 to 1.17 + 0.84 per day). However, only Group A patients showed
significant improvement in left ventricular ejection fraction (42.25 + 9.96 to
52.67 + 12.32% vs 51.83 + 5.99 to 49.83 + 2.52%) and reduction in left
ventricular mass (159.18 + 51.11 to 127.47 + 52.40 gm/m2 vs 159.11 + 38.92 to
160.78 + 54.23 gm/m2) on echocardiography following three months of therapy.
Both patients with ischaemic cardiomyopathy showed significant symptomatic
relief in coronary heart failure from NYHA class III to NYHA class I. Prolonged
administration of T. arjuna did not show any adverse effects on renal, hepatic
and haematological parameters. The potential of T. arjuna to improve left
ventricular ejection fraction and reduce left ventricular mass in coronary
artery disease needs to be harnessed.
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3) J Assoc Physicians India. 2001 Feb;49:231-5.
Antioxidant and hypocholesterolaemic effects of Terminalia arjuna tree-bark
powder: a randomised placebo-controlled trial.
Gupta R, Singhal S, Goyle A, Sharma VN.
Department of Medicine, Monilek Hospital and Research Centre, Jaipur.
OBJECTIVE: To evaluate the antioxidant and hypocholesterolaemic
effects of Terminalia arjuna tree bark (a popular cardiotonic substance in
Indian pharmacopoeia) and to compare it with a known antioxidant, vitamin E, we
performed a randomized controlled trial.
METHODS: One hundred and five successive patients with coronary
heart disease (CHD) presenting to our centre were recruited and using a
Latin-square design divided into 3 groups of 35 each. The groups were matched
for age, lifestyle and dietary variables, clinical diagnosis and drug treatment
status. None of the patients was on lipid-lowering drugs. Supplemental vitamins
were stopped for one month before study began and American Heart Association
Step II dietary advice was given to all. At baseline, total cholesterol,
triglycerides, HDL and LDL cholesterol and lipid peroxide estimated as
thiobarbituric acid reactive substances (TBARS) were determined. Group I
received placebo capsules; Group II vitamin E capsules 400 units/day; and Group
III received finely pulverized T. arjuna tree bark-powder (500 mg) in capsules
daily. Lipids and lipid peroxide levels were determined at 30 days follow-up.
RESULTS: Response rate in various groups varied from 86% to 91%. No significant
changes in total, HDL, LDL cholesterol and triglycerides levels were seen in
Groups I and II (paired t-test p > 0.05). In Group III there was a
significant decrease in total cholesterol (-9.7 +/- 12.7%), and LDL cholesterol
(-15.8 +/- 25.6%) (paired t-test p < 0.01). Lipid peroxide levels decreased
significantly in both the treatment groups (p < 0.01). This decrease was
more in vitamin E group (-36.4 +/- 17.7%) as compared to the T. arjuna group
(-29.3 +/- 18.9%).
CONCLUSIONS: Terminalia arjuna tree bark powder has significant
antioxidant action that is comparable to vitamin E. In addition, it also has a
significant hypocholesterolaemic effect.
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4) Indian Heart J. 2002 Mar-Apr;54(2):170-5.
Efficacy of Terminalia arjuna in chronic stable angina: a double-blind,
placebo-controlled, crossover study comparing Terminalia arjuna with isosorbide
mononitrate.
Bharani A, Ganguli A, Mathur LK, Jamra Y, Raman PG.
Department of Medicine, MGM Medical College and MY Hospital, Indore, MP.
tanmaybharani@im.eth.net
BACKGROUND: Terminalia arjuna, an Indian medicinal plant, has
been reported to have beneficial effects in patients with ischemic heart
disease in a number of small, open studies. The need for a double-blind,
randomized, placebo-controlled study with adequate sample size has long been
felt. The bark extract (IPC-53) contains acids (arjunic acid, terminic acid),
glycosides (arjunetin arjunosides I-IV), strong antioxidants (flavones,
tannins, oligomeric proanthocyanidins), minerals. etc. and exhibits antifailure
and anti-ischemic properties.
METHODS AND RESULTS: Fifty-eight males with chronic stable
angina (NYHA class II-III) with evidence of provocable ischemia on treadmill
exercise test received Terminalia arjuna (500 mg 8 hourly), isosorbide
mononitrate (40 mg/daily) or a matching placebo for one week each, separated by
a wash-out period of at least three days in a randomized, double-blind,
crossover design. They underwent clinical, biochemical and treadmill exercise
evaluation at the end of each therapy which were compared during the three
therapy periods. Terminalia arjuna therapy was associated with significant
decrease in the frequency of angina and need for isosorbide dinitrate
(5.69+/-6.91 mg/week v. 18.22+/-9.29 mg/week during placebo therapy,
p<0.005). The treadmill exercise test parameters improved significantly
during therapy with Terminalia arjuna compared to those with placebo. The total
duration of exercise increased (6.14+/-2.51 min v. 4.76+/-2.38 min,
p<0.005), maximal ST depression during the longest equivalent stages of
submaximal exercise decreased (1.41+/-0.55 mm v. 2.21+/-0.56 mm, p<0.005),
time to recovery decreased (6.49+/-2.37 min v. 9.27+/-3.39 min, p<0.005) and
higher double products were achieved (25.75+/-4.81x10(3) v. 23.11+/-4.83x10(3),
p<0.005) during Terminalia arjuna therapy. Similar improvements in clinical
and treadmill exercise test parameters were observed with isosorbide
mononitrate compared to placebo therapy. No significant differences were
observed in clinical or treadmill exercise test parameters when Terminalia
arjuna and isosorbide mononitrate therapies were compared. No significant
untoward effects were reported during Terminalia arjuna therapy.
CONCLUSIONS: Terminalia arjuna bark extract, 500 mg 8 hourly,
given to patients with stable angina with provocable ischemia on treadmill
exercise, led to improvement in clinical and treadmill exercise parameters as
compared to placebo therapy. These benefits were similar to those observed with
isosorbide mononitrate (40 mg/day) therapy and the extract was well tolerated.
Limitations of this study include applicability of the results to only men with
chronic stable angina but not necessarily to women, as they were not studied.
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5) Altern Med Rev. 1998 Dec;3(6):422-31.
Botanical influences on cardiovascular disease.
Miller AL.
Several botanicals, including Crataegus oxycantha, Terminalia arjuna, Inula racemosa, and Astragalus membranaceus, have been found to have therapeutic benefit for the treatment of cardiovascular disease. Crataegus oxycantha has been used traditionally as a cardiac tonic and current uses include treatment for angina, hypertension, arrhythmias, and congestive heart failure. Animal studies have also indicated that Crataegus extracts may also have potential use as anti-ischemic and lipid-lowering agents. The bark of the Terminalia arjuna tree has a long history of use as a cardiac tonic as well, and has been indicated in the treatment of coronary artery disease, heart failure, hypercholesterolemia and for relief of anginal pain. Additionally, it has been found to have antibacterial and antimutagenic properties. Inula racemosa, also known as Pushkarmoola, is another traditional Ayurvedic botanical that has potential cardioprotective benefit. In human trials, a combination of Inula racemosa and Commiphora mukul was shown to be superior to nitroglycerin in reducing the chest pain and dyspnea associated with angina. Astragalus membranaceus, a Chinese herb, is often used as a "Qi tonifier" and has been studied for its therapeutic benefit in treatment of ischemic heart disease, myocardial infarction, heart failure, and relief of anginal pain. Clinical studies have indicated that its in vitro antioxidant activity is the mechanism by which it affords its cardioprotective benefit.