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1.
Antihypertensive efficacy and safety of a standardized herbal medicinal product of Hibiscus sabdariffa and Olea europaea extracts (NW Roselle): A phase-II, randomized, double-blind, captopril-controlled clinical trial.
Elkafrawy, N, Younes, K, Naguib, A, Badr, H, Kamal Zewain, S, Kamel, M, Raoof, GFA, M El-Desoky, A, Mohamed, S
Phytotherapy research : PTR. 2020;(12):3379-3387
Abstract
Hypertension is a public health concern that needs immediate attention upon diagnosis. The demand for natural alternatives is on the rise; Hibiscus sabdariffa and Olea europaea are traditionally used for hypertension management in Egypt. In this study, we aimed to investigate the antihypertensive efficacy and safety of two doses of an herbal product of Hibiscus sabdariffa calyxes and Olea europaea leaves (NW Roselle) in Egyptian patients with grade 1 essential hypertension. We equally randomized 134 patients to receive captopril 25 mg, low-dose NW Roselle, or high-dose NW Roselle BID for 8 weeks. No significant decrease was found in systolic blood pressure or diastolic blood pressure when we compared low-dose NW Roselle and high-dose NW Roselle to captopril (p > .05). In all groups, mean reduction in BP at 8 weeks was significant; 16.4/9.9 mmHg (p < .0001), 15.4/9.6 mmHg (p < .0001), and 14.9/9.4 mmHg (p < .0001) with captopril, low-dose NW Roselle, and high-dose NW Roselle respectively. In addition, low-dose NW Roselle induced a significant reduction in the mean level of triglycerides (17.56 mg/dL; p = .038). In conclusion, NW Roselle had comparable antihypertensive efficacy and safety to captopril in Egyptian patients with grade 1 essential hypertension.
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2.
[Clinical observation of xuesaitong injection on the treatment of chronic respiratory failure].
Chen, N, Wang, Q, Huang, L, Li, D
Zhong yao cai = Zhongyaocai = Journal of Chinese medicinal materials. 2004;(9):704-6
Abstract
OBJECTIVE To observe the effect of Xuesaitong Injection on the treatment of chronic respiratory failure. METHODS 86 cases were classified into two groups randomly. The control group was given routine therapy with western medicine. Based on the regime, the test group received Xuesaitong injection, i.v., once a day. Therapeutic course was 14 days in every patient. RESULTS The overall effective rate (81.3%) of test group was higher than that of control group (P < 0.05). The indexes of the test group related to blood gas analysis and blood rheology were significantly improved in comparison with the control group. CONCLUSION Xuesaitong Injection has an apparent effect on chronic respiratory failure.
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3.
Hypocholesterolemic property of Yucca schidigera and Quillaja saponaria extracts in human body.
Kim, SW, Park, SK, Kang, SI, Kang, HC, Oh, HJ, Bae, CY, Bae, DH
Archives of pharmacal research. 2003;(12):1042-6
Abstract
This study was undertaken to observe the effects of the blend of partially purified Yucca schidigera and Quillaja saponaria extracts on cholesterol levels in the human's blood and gastrointestinal functions, and to determine if a new cholesterol-lowering drug can be developed by the further purification of the extracts. Ultrafiltration and sequential diafiltration increased the amounts of steroidal saponin in aqueous yucca extract and terpenoid saponin in aqueous quillaja extract from 9.3% and 21.4% to 17.2% and 61.8%, respectively. Taking 0.9 mg of the blend (6:4, v:v) of the resulting filtrates a day for 4 weeks resulted in the decreases in total and LDL cholesterol levels in blood plasma of hyper-cholesterolemic patients with enhancement in gastrointestinal symptoms of patients.
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4.
Efficacy and safety of a Butcher's broom preparation (Ruscus aculeatus L. extract) compared to placebo in patients suffering from chronic venous insufficiency.
Vanscheidt, W, Jost, V, Wolna, P, Lücker, PW, Müller, A, Theurer, C, Patz, B, Grützner, KI
Arzneimittel-Forschung. 2002;(4):243-50
Abstract
Extracts from Butcher's broom rhizome (Ruscus aculeatus) have been widely used in the oral treatment of lower leg edema in patients with chronic venous insufficiency. The aim of the present multi-center, double-blind, randomized, placebo-controlled trial was to confirm the efficacy and safety of a ruscus extract (Fagorutin Ruscus Kapseln) according to the latest scientific standards. 166 women suffering from chronic venous insufficiency (Widmer grade I and II, CEAP (Clinical signs, Etiological classification, Anatomic distribution, Pathophysiology) 3-4) were included. The data of 148 patients (30-89 years, 150-182 cm height, 49-97 kg body weight) with a mean disease duration of 14.6 years in the ruscus extract group and 15.1 years in the placebo group were eligible for the intent-to-treat-analysis. The primary parameter was the area under baseline of the leg volume changes over 12 weeks (AUB0-12). Secondary parameters were the changes in circumference of the lower leg and the ankle, changes in subjective symptoms and quality of life, the overall efficacy and tolerability and safety parameters. The study was carried out according to the guidelines for testing drugs for chronic venous insufficiency. There were significant differences between the treatment groups ruscus and placebo for the AUB0-12 (-827 ml x day), for the change of leg volume after 8 and 12 weeks of treatment (-16.5 ml and -20.5 ml), for changes in ankle and leg circumferences after 8 and 12 weeks of treatment, and for the changes in subjective symptoms, heavy tired legs and sensation of tension (week 12). For the changes in the symptoms heavy lower legs, sensation of tension, and tingling sensation a significant positive correlation with the changes in leg volume was shown. Overall assessment of efficacy was significantly better for ruscus extract compared to placebo. Overall tolerability for both treatments was assessed as good and very good. Of all 48 adverse events occurring in both treatment groups, 22 were reported in the ruscus group, one of them was considered to be related to the study medication (unlikely). Considering the study duration of three months it is concluded, that ruscus extract, in the recommended daily dosage according to the German monograph, is a safe and effective treatment for patients suffering from chronic venous insufficiency.
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5.
Efficacy and safety of freeze-dried cat's claw in osteoarthritis of the knee: mechanisms of action of the species Uncaria guianensis.
Piscoya, J, Rodriguez, Z, Bustamante, SA, Okuhama, NN, Miller, MJ, Sandoval, M
Inflammation research : official journal of the European Histamine Research Society ... [et al.]. 2001;(9):442-8
Abstract
AIM: The purpose of this investigation was to evaluate the ability of cat's claw, an Amazonian medicinal plant, to treat osteoarthritis of the knee, collect safety and tolerance information and compare the antioxidant, and anti-inflammatory actions of Uncaria guianensis and Uncaria tomentosa in vitro. MATERIALS AND METHODS Forty-five patients with osteoarthritis of the knee were recruited, 30 were treated with freeze-dried U guianensis, and 15 with placebo. Hematological parameters were assessed on entry and exit of the four-week trial. Pain, medical and subject assessment scores and adverse effects were collected at weeks 1, 2 and 4. The antioxidant and anti-inflammatory activity of the cat's claw species was determined by the alpha,alpha-diphenyl-beta-picrylhydrazyl (DPPH) free radical scavenging method. Inhibition of TNFalpha and prostaglandin E2 (PGE2) production was determined in RAW 264.7 cells by ELISA. RESULTS Cat's claw had no deleterious effects on blood or liver function or other significant side-effects compared to placebo. Pain associated with activity, medical and patient assessment scores were all significantly reduced, with benefits occurring within the first week of therapy. Knee pain at rest or at night, and knee circumference were not significantly reduced by cat's claw during this brief trial. In vitro tests indicated that U guianensis and U. tomentosa were equivalent at quenching DPPH radicals (EC50, 13.6-21.7 microg/ml) as well as inhibiting TNFalpha production. However, the latter action was registered at much lower concentrations (EC50, 10.2-10.9 ng/ml). Cat's claw (10 microg/ml) had no effect on basal PGE2 production, but reduced LPS-induced PGE2 release (P < 0.05), but at higher concentrations than that required for TNFalpha inhibition. CONCLUSION Cat's claw is an effective treatment for osteoarthritis. The species, U guianensis and U tomentosa are equiactive. They are effective antioxidants, but their anti-inflammatory properties may result from their ability to inhibit TNFalpha and to a lesser extent PGE2 production.
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6.
Antioxidant and hypocholesterolaemic effects of Terminalia arjuna tree-bark powder: a randomised placebo-controlled trial.
Gupta, R, Singhal, S, Goyle, A, Sharma, VN
The Journal of the Association of Physicians of India. 2001;:231-5
Abstract
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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7.
Treatment of acute tonsillitis with a fixed-combination herbal preparation.
Rau, E
Advances in therapy. 2000;(4):197-203
Abstract
In an observational study involving 10 non-hospital-affiliated physicians, 48 patients between 6 and 73 years of age with symptoms of acute tonsillitis were treated with either a liquid or tablet formulation of a herbal compound of Phytolacca, Guajacum, and Capsicum. More than half of the patients reported marked alleviation of the principal symptom, moderate or severe difficulty in swallowing, within the first 5 days of treatment. Comparable improvements occurred in other outcome measures, including earache, headache, and fatigue. No adverse side effects were reported.
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8.
Double-blind, placebo-controlled pilot and phase III study of activity of standardized Andrographis paniculata Herba Nees extract fixed combination (Kan jang) in the treatment of uncomplicated upper-respiratory tract infection.
Melchior, J, Spasov, AA, Ostrovskij, OV, Bulanov, AE, Wikman, G
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2000;(5):341-50
Abstract
Two randomized double-blind, placebo-controlled parallel group clinical trials were performed to investigate the effect of a standardized extract (SHA-10) of Andrographis paniculata fixed combination (Kan jang) in the treatment of uncomplicated upper-respiratory tract infections. 46 patients in the pilot study and 179 patients in the phase III study completed the study according to the protocol. Medication was taken three times daily for a minimum of 3 days and a maximum of 8 days for the pilot study, and for exactly three days in the phase III study. The primary outcome measures in the patients self-evaluation were: related to pain in the muscle, cough, throat symptoms, headache, nasal symptoms and eye symptoms and temperature. The physician's fixed score diagnosis was based mainly on sign/symptoms: ears, nose, oral cavity, lymph glands-tonsils and eyes. The total symptom score showed a tendency toward improvement in the pilot study (p = 0,08), while both the total symptom score and total diagnosis score showed highly significant improvement (p < or = 0.0006 resp. 0.003) in the verum group as compared with the placebo. In both studies throat symptoms/signs, were found to show the most significant improvement.
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9.
Antihypertensive and antihyperlipidemic effects of Achillea wilhelmsii.
Asgary, S, Naderi, GH, Sarrafzadegan, N, Mohammadifard, N, Mostafavi, S, Vakili, R
Drugs under experimental and clinical research. 2000;(3):89-93
Abstract
Achillea wilhelmsii C. Koch (Asteraceae) is widely found in different parts of Iran. This plant is full of flavonoids and sesquiterpene lactones, which have been shown to be effective in lowering blood lipids and hypertension. We conducted a double-blind placebo controlled clinical trial to study the antihyperlipidemic and antihypertensive effects of Achillea drops. We randomly selected 120 men and women, aged 40-60 years, and divided them in two distinct groups of moderate hyperlipidemic and primary hypertensive subjects. They were treated either with hydroalcoholic extract or with placebo in the form of 15-20 drops twice daily for more than 6 months. Blood pressure and serum lipids (total cholesterol, triglyceride, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol) were measured in the groups for 3 periods of 2 months each. The mean and standard deviation of alternations in these variables between the group taking placebo and that taking drugs was calculated by Student's t-test. The results showed a significant decrease in triglycerides after of 2 months while decreases in triglycerides, total cholesterol and LDL-cholesterol were significant after 4 months. Levels of HDL-cholesterol were significantly increased after 6 months' treatment. A significant decrease was observed in diastolic and systolic blood pressure after 2 and 6 months, respectively (p < 0.05).
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10.
A phase I trial of andrographolide in HIV positive patients and normal volunteers.
Calabrese, C, Berman, SH, Babish, JG, Ma, X, Shinto, L, Dorr, M, Wells, K, Wenner, CA, Standish, LJ
Phytotherapy research : PTR. 2000;(5):333-8
Abstract
A phase I dose-escalating clinical trial of andrographolide from Andrographis paniculata was conducted in 13 HIV positive patients and five HIV uninfected, healthy volunteers. The objectives were primarily to assess safety and tolerability and secondarily to assess effects on plasma virion HIV-1 RNA levels and CD4(+) lymphocyte levels. No subjects used antiretroviral medications during the trial. Those with liver or renal abnormalities were excluded. The planned regimen was 5 mg/kg bodyweight for 3 weeks, escalating to 10 mg/kg bodyweight for 3 weeks, and to 20 mg/kg bodyweight for a final 3 weeks. The trial was interrupted at 6 weeks due to adverse events including an anaphylactic reaction in one patient. All adverse events had resolved by the end of observation. A significant rise in the mean CD4(+) lymphocyte level of HIV subjects occurred after administration of 10 mg/kg andrographolide (from a baseline of 405 cells/mm(3) to 501 cells/mm(3); p = 0.002). There were no statistically significant changes in mean plasma HIV-1 RNA levels throughout the trial. Andrographolide may inhibit HIV-induced cell cycle dysregulation, leading to a rise in CD4(+) lymphocyte levels in HIV-1 infected individuals.