scholarly journals Effects of 12-Week Supplementation of a Polyherbal Formulation in Old Adults with Prehypertension/Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Tian Shen ◽  
Guoqiang Xing ◽  
Jingfen Zhu ◽  
Yong Cai ◽  
Shuxian Zhang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Placebo Group ◽  
Controlled Trial ◽  
Adult Population ◽  
Chest Tightness ◽  
Double Blind ◽  
Old Adults ◽  
Severity Scores ◽  
Rapid Heart Rate

Background. Uncontrolled blood pressure is the leading cause of mortality and disability due to associated cerebral and cardiovascular diseases and kidney failure. More than one-third of the old adult population have hypertension or prehypertension and many of their blood pressure are poorly controlled. Objective. We hypothesized that plant extracts-based antioxidants may benefit those with prehypertension/hypertension. Method. One hundred age- and gender-matched healthy older adults were randomly assigned to receive HyperBalance capsules (n=50) or placebo (n=50) at Tang-Qiao Community Health Service Center, Shanghai. Blood pressure and severity scores of hypertension treatment-related symptoms (dizziness, headache, ringing/buzzing in ears, rapid heart rate, and chest tightness) were evaluated before and after the 12-week intervention. Results. Ninety-eight people completed the study, with 2 dropouts in the placebo group before the end of the study. Forty-one subjects (82%) of the HyperBalance group and 40 subjects (83.3%) of the placebo group had prehypertension (systolic blood pressures (SBP) between 130-139 and diastolic blood pressure (DBP) between 85-89mmHg), and 9 subjects (18%) in the HyperBalance group and 8 subjects (16.7%) in the placebo group had hypertension (≥140/90mmHg) before the intervention. HyperBalance significantly (P<0.01) reduced SBP from 136.18±4.38 to 124.14±3.96 mmHg and reduced DBP from 82.45±2.91 to 80.24±2.41mmHg, respectively, and reversed all 9 hypertension people to normotension or prehypertension state, whereas the placebo moderately reduced SBP from 135.79±4.22 to 132.35±4.656mmHg and reduced DBP from 82.90±3.07 to 82.27±3.01mmHg. All symptom severity scores became significantly lower in the HyperBalance group than in the placebo group after HyperBalance intervention: dizziness (0.82±0.44; vs 2.02±0.64, P<0.01); headache (0.46±0.50; vs 1.81±0.61, P<0.01); ringing/buzzing in ears (0.44±0.50; vs 1.04±0.29, P<0.01); and rapid heart rate and chest tightness (0.30±0.46; vs 0.92±0.28, P<0.01). Conclusion. Polyherbal supplementation such as HyperBalance could benefit old adults with prehypertension/hypertension and improve treatment-related symptoms. Further studies are needed to validate the current findings.

The effect of nadolol on heart rate in hyperthyroidism. A controlled trial

1987 ◽  
Vol 114 (1) ◽  
pp. 102-106
Author(s):  
J. H. Lazarus ◽  
J. C. Kingswood ◽  
R. John
Keyword(s):  
Heart Rate ◽  
Placebo Group ◽  
Controlled Trial ◽  
Circadian Variation ◽  
Maximum Heart Rate ◽  
Double Blind ◽  
Early Management ◽  
The Mean ◽  
To Receive ◽  
Hyperthyroid Patients

Abstract. Twenty hyperthyroid patients were randomly assigned in a double-blind fashion to receive either nadolol 80 mg/day or placebo for 2 weeks; all patients then took carbimazole as well from 2–6 weeks. Twenty-four hour Holter ECG recordings at 0, 2 and 6 weeks showed that nadolol reduced the mean maximum heart rate by 19.9% (P < 0.0005) at 2 weeks and by 30.3% (P < 0.0005) at 6 weeks compared to 5.2% (ns) and 18.3% (P < 0.0005) in patients taking placebo. There was no alteration of the normal circadian variation of heart rate by nadolol. The minimum heart rate before therapy was significantly correlated with FT4 (r = 0.52) and with FT3 (r = 0.44). The percentage of time per hour during which the heart rate was greater than 100 was reduced by 79% at week 2 by nadolol compared to 22% in the placebo group. At the 6 week point the placebo group still had a tachycardia (mean maximum heart rate 101.6 beats/min ± 15.2 sd) compared to the nadolol group (80.4 ± 7.7). Nadolol did not cause excessive bradycardia. It is effective in the early management of hyperthyroidism and should be given for at least the first 4–6 weeks.

Phase I Safety Assessment of Intrathecal Injection of an American Formulation of Adenosine in Humans

2002 ◽  
Vol 96 (1) ◽  
pp. 24-28 ◽  
Author(s):  
James C. Eisenach ◽  
David D. Hood ◽  
Regina Curry
Keyword(s):  
Carbon Dioxide ◽  
Blood Pressure ◽  
Heart Rate ◽  
Phase I ◽  
Controlled Trial ◽  
Intrathecal Injection ◽  
Open Label ◽  
Double Blind ◽  
End Tidal Carbon Dioxide ◽  
End Tidal

Background Preclinical studies of intrathecal adenosine suggest it may be effective in the treatment of acute and chronic pain in humans. A phase I safety trial of the intrathecal injection of a mannitol-containing formulation of adenosine in Sweden showed a considerable incidence of backache. We performed a phase I safety trial of intrathecal injection of the American formulation of adenosine, which lacks mannitol. Methods Following US Food and Drug Administration and institutional review board approval and written informed consent, 65 volunteers were studied in two trials: an open-label, dose-escalating trial with intrathecal adenosine doses of 0.25-2.0 mg (25 subjects) and a double-blind, placebo-controlled trial of adenosine, 2 mg (40 subjects). Blood pressure, heart rate, end-tidal carbon dioxide, and sensory, motor, and reflex neurologic functions were systematically examined for 24 h after injection, and volunteers were contacted by telephone at times up to 6 months after injection. Results Intrathecal adenosine did not affect blood pressure, heart rate, end-tidal carbon dioxide, or neurologic function. Headache was reported by 10 and back pain was reported by 8 of 30 subjects exposed to adenosine in the second double-blind trial, whereas none of these symptoms was reported by the 10 saline-treated subjects. Conclusion These data support further investigation of intrathecal adenosine for analgesia in humans and suggest that this agent does not produce a high incidence of severe side effects.

Efficacy of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertension: a randomized, double-blind, placebo-controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mansoor Ahmad Siddiqui ◽  
Malik Itrat ◽  
Abdul Mobeen ◽  
Md Imran Khan
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Diastolic Blood Pressure ◽  
Controlled Trial ◽  
Test Group ◽  
Controlled Clinical Trial ◽  
Tribulus Terrestris ◽  
Blood Pressure Lowering Effect ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background Prehypertension is a state of above-normal blood pressure that does not meet the criteria for the diagnosis of hypertension and its prevalence estimated in population-based samples ranges from 22 to 52%. It conveys potentially many deleterious consequences such as high risk of progression to hypertension and cardiovascular disease later in life. Objectives The present study was conducted to evaluate the blood pressure-lowering effect of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertensive individuals. Methods This randomized, double-blind, placebo-controlled, clinical trial was conducted at the National Institute of Unani Medicine, Hospital, Bengaluru, after approval by the Institutional Ethics Committee. Prehypertensive individuals over 18 years of age were enrolled after obtaining their written informed consent and were randomly allocated to the test or placebo group. The test and placebo groups were administered powdered dried fruits of Khār-i-khasak (6g) and matched placebo (6g) in three divided doses for two months respectively. The efficacy assessment was determined by changes in systolic and diastolic blood pressures. Results Both systolic and diastolic blood pressure showed a significant decline in the test group (p<0.001) as compared to the placebo group. The average decline in systolic/diastolic blood pressure was −7.7/5.5 mmHg in the test group and −1.9/0.2 mmHg in the placebo group. During the post-therapy follow-up period, no prehypertensive developed full-blown hypertension in either group. Safety parameters were found to be within normal limits. Conclusions The test drug Khār-i-khasak (T. terrestris Linn.) was found to be effective and safe in lowering blood pressure compared to placebo in prehypertensive individuals.

scholarly journals The Effect of L-Theanine Incorporated in a Functional Food Product (Mango Sorbet) on Physiological Responses in Healthy Males: A Pilot Randomised Controlled Trial

Foods ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. 371 ◽  
Author(s):  
Jackson Williams ◽  
Andrew J. McKune ◽  
Ekavi N. Georgousopoulou ◽  
Jane Kellett ◽  
Nathan M. D’Cunha ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
High Frequency ◽  
Functional Food ◽  
Controlled Trial ◽  
Physiological Responses ◽  
Area Under The Curve ◽  
Food Product ◽  
Food Matrix ◽  
Double Blind

Consumption of L-Theanine (L-THE) has been associated with a sensation of relaxation, as well as a reduction of stress. However, these physiological responses have yet to be elucidated in humans where L-THE is compared alongside food or as a functional ingredient within the food matrix. The aim of this study was to determine the physiological responses of a single intake of a potential functional food product (mango sorbet) containing L-THE (ms-L-THE; 200 mgw/w) in comparison to a flavour and colour-matched placebo (ms). Eighteen healthy male participants were recruited in this randomised, double-blind, placebo-controlled trial. The participants were required to consume ms-L-THE or placebo and their blood pressure (BP) (systolic and diastolic), heart rate (HR), and heart rate variability (HRV) were monitored continuously over 90 minutes. Eleven males (age 27.7 ± 10.8 years) completed the study. Changes in area under the curve for systolic and diastolic blood pressure and HRV over the 90 minute observation period indicated no differences between the three conditions (all p > 0.05) or within individual groups (all p > 0.05). The values for heart rate were also not different in the placebo group (p = 0.996) and treatment group (p = 0.066), while there was a difference seen at the baseline (p = 0.003). Based on the findings of this study, L-THE incorporated in a food matrix (mango sorbet) demonstrated no reduction in BP or HR and showed no significant parasympathetic interaction as determined by HRV high-frequency band and low-frequency/high-frequency ratio. Further studies should be focussed towards the comparison of pure L-THE and incorporation within the food matrix to warrant recommendations of L-THE alongside food consumption.

Prophylactic use of intravenous tramadol vs intravenous nalbuphine for control of postspinal shivering after knee arthroscopy: a randomized double-blind placebo controlled trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
A M Fahmy ◽  
I M Esmat ◽  
T Shabana ◽  
M S M Etman
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Knee Arthroscopy ◽  
Controlled Trial ◽  
Saline Group ◽  
Plasma Catecholamine ◽  
University Hospitals ◽  
Double Blind ◽  
Significant Difference ◽  
Plasma Catecholamine Concentrations

Abstract Background Post-anesthetic shivering refers to spontaneous, involuntary, rhythmic, oscillating and tremor-like muscle hyperactivity that increases metabolic heat production up to 600% after general or regional anesthesia. Shivering is not only subjectively unpleasant but is physiologically stressful because it elevates blood pressure, heart rate, oxygen consumption, and plasma catecholamine concentrations. Moreover, shivering may aggravate pain and hinder wound closure by simply stretching surgical incisions. Objective The aim of this work is to compare the efficacy of intravenous tramadol VS nalbuphine for prevention of post spinal shivering during knee arthroscopy. Methods This prospective randomized double blinded study was carried in Ain Shams University hospitals on 90 patients scheduled for knee arthroscopy. Patients were randomized into three groups 30 patients each: Group C: patients received normal saline 0.9%) intravenously. Group T: Patients received Tramadol 0.5 mg/kg intravenously. Group N: Patients received nalbuphine 0.1mg/kg intravenously. All drugs were given immediately after intra thecal injection of the anaesthetic drugs and returning to the supine position. Results The study revealed that the incidence of shivering was less in the tramadol (23.3%) and nalbuphine (26.7%) groups compared to the saline group (56.7%) (P &lt; 0.05) with no significant difference between Nalbuphine and Tramadol groups (p &gt; 0.05). The mean grade of shivering was comparable between the three groups (P &gt; 0.05). Shivering onset was significantly earlier in the saline group (24.1±2.9 min) compared to Nalbuphine (32.3±4.9min) and Tramadol (36.4±4.3min) groups (P &lt; 0.05) with no significant difference between Nalbuphine and Tramadol groups (p &gt; 0.05). There were no significant differences among the three groups as regards hemodynamics (Heart rate and mean blood pressure), respiratory rate, oxygen saturations, body temperature, the incidence of nausea or vomiting (P &gt; 0.05). While sedation grade was significantly highest in Nalbuphine group followed by Tramadol group and least in Saline group (P &lt; 0.001). Conclusion The current study revealed that both tramadol 0.5mg/kg and balbuphine 0.1mg/kg was effective in prevention of post spinal shivering in patients undergoing knee arthroscopy.

scholarly journals Effects of prayer on the vital signs of patients with chronic kidney disease: randomized controlled trial

2017 ◽  
Vol 51 (0) ◽  
Author(s):  
Thaila Oliveira Zatiti Brasileiro ◽  
Andressa Anunciação de Oliveira Prado ◽  
Bianca Bacelar de Assis ◽  
Denismar Alves Nogueira ◽  
Rogério Silva Lima ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Chronic Kidney Disease ◽  
Heart Rate ◽  
Kidney Disease ◽  
Respiratory Rate ◽  
Controlled Trial ◽  
Group Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind

Abstract OBJECTIVE To assess the effect of prayer on blood pressure, heart rate and respiratory rate in patients with chronic kidney disease and learn their perception of the intervention. METHOD A randomized controlledtrial, double blind with a sample of volunteers, randomized into an intervention group (n=42) and a control group (n=37). Questionnaires addressing socio-demographic, clinical and spiritual characteristics and the Duke University Religious Index were applied. Blood pressure, heart rate and respiratory rate were measured. The prayer was conducted at three different moments on alternating weeks. The qualitative data were organized and analyzed through Thematic Analysis. RESULTS The sample consisted of 95 randomized volunteers. In the intra-group analysis, a statistically significant reduction (P<0001) of blood pressure, heart rate and respiratory rate was observed in all evaluations of the people who were prayed for. The qualitative analysis resulted in the themes Prayer in a "Place of Suffering" and Positive Evaluation and in the sub-themes Relief from Suffering, Hope for Improvement, and Coping with Hemodialysis. CONCLUSIONPrayer reduced blood pressure, heart rate and respiratory rate in patients who suffer from chronic kidney disease, and the volunteers’ evaluation of the intervention was positive.BrazilianClinicalTrials Registry: RBR-2zv39y.

scholarly journals Prevention of Tachycardia with Atenolol Pretreatment for Carotid Endarterectomy under Cervical Plexus Blockade

1992 ◽  
Vol 20 (2) ◽  
pp. 161-164 ◽  
Author(s):  
M. J. Davies ◽  
R. H. Dysart ◽  
B. S. Silbert ◽  
D. A. Scott ◽  
R. J. Cook
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Carotid Endarterectomy ◽  
Controlled Trial ◽  
Cervical Plexus ◽  
Double Blind ◽  
Cervical Plexus Block ◽  
Randomised Controlled ◽  
Plexus Block ◽  
Atenolol Group

A double-blind, randomised, controlled trial of forty patients was carried out to determine if oral atenolol pretreatment would reduce the incidence of tachycardia during carotid endarterectomy performed under cervical plexus block. Twenty patients received a placebo and twenty patients 50 mg of atenolol two hours prior to surgery. The superficial and deep cervical blocks were performed with 1.5% lignocaine containing 1:200,000 adrenaline. The patients were monitored with the V5 lead of the electrocardiogram and intraarterial blood pressure. These measurements were recorded on a correctly calibrated paper recorder. Tachycardia (heart rate > 90 beats per minute for more than three minutes) occurred in thirteen patients in the placebo group and two patients in the atenolol group (P<0.01). There was no difference in the occurrence of bradycardia, hypotension or hypertension between the two groups. It is concluded that atenolol pretreatment is an effective method of reducing the incidence of tachycardia during carotid endarterectomy performed under cervical plexus blockade.

scholarly journals An evaluation of efficacy of addition of dexmedetomidine /clonidine to fentanyl in attenuation of pressor response of laryngoscopy and intubation: A prospective double blind randomized controlled trial

2021 ◽  
Vol 8 (2) ◽  
pp. 283-287
Author(s):  
Yogendra Singhal ◽  
Rekha Meena ◽  
Lalit Kumar Raiger
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Placebo Group ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Pressor Response ◽  
Controlled Trial ◽  
Study Drug ◽  
Drug Infusion ◽  
Study Drug Infusion

Laryngoscopy and intubation have been associated with increased sympathetic responses such as hypertension, tachycardia, arrhythmias, and myocardial infarction. This response is usually transient and variable but might be life threatening in cardiovascular and cerebrovascular compromised patients. So controlling this response is utmost goal of anaesthesia. We evaluated the effectiveness of dexemedetomidine/clonidine to attenuate pressor response.Evaluation of efficacy of addition of Dexemedetomidine/ clonidine to fentanyl in attenuation of pressor response of laryngoscopy and intubation.96 patients were enrolled and randomly divided in three groups having 32 patients each. Group NS received 10 ml normal saline, Group CL received 2mcg/kg Inj. Clonidine and Group DE received 1mcg/kg Inj. Dexemedetomidine infusion over 10 min before laryngoscopy. Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure were studied immediately after premedication, 10 min after study drug infusion and then at 1, 2,3,4,5 and 10 min intervals. : There was significant fall in mean HR and mean MAP after 10 min of study drug infusion. Clonidine and dexemedetomidine groups had significantly less rise in heart rate and mean arterial pressure after intubation and then at 1,2,3,4,5 and 10 min time intervals compared to placebo group. No significant side effects were observed.: Use of dexemedetomidine 10 min before laryngoscopy was associated with significantly less rise in pressor response compared to placebo group. Dexemedetomidine better attenuates the pressor response compared to clonidine but the difference was statistically insignificant.

scholarly journals The Effect of Omega-3 Fatty Acids Supplementation on the Improvement of Metabolic Syndrome in Patients with Ischemic Heart Disease: A Double-blind, Randomised, Placebo-controlled Trial

2020 ◽  
Author(s):  
Asma Zamanian ◽  
Rasoul Zarrin ◽  
Samira Faraji ◽  
Parvin Ayramloy ◽  
Behzad Rahimi Darabad
Keyword(s):  
Blood Pressure ◽  
Metabolic Syndrome ◽  
Fatty Acids ◽  
Placebo Group ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Cardiac Ischemia ◽  
Omega 3 Fatty Acids ◽  
Omega 3 ◽  
Double Blind

Introduction: Metabolic syndrome is a set of metabolic abnormalities that increase the risk of cardiovascular disease. Omega-3 fatty acids may play a role in improving metabolic syndrome by affecting endothelial status. Aim: To study the effect of omega-3 fatty acids on metabolic syndrome in patients with cardiac ischemia. Materials and Methods: This was a 12-weeks, double-blind, randomised, placebo-controlled trial. Ninety patients with a history of cardiac ischemia and metabolic syndrome were randomly divided into intervention (n=45) and placebo (n=45) groups. In the end, 86 people completed the study. The intervention group consumed daily Omega-3 capsules containing 1000 mg fish oil, 180 mg EPA and 120 mg DHA. The placebo group took gelatin-containing capsules. Serum triglycerides, Fasting Blood Sugar (FBS), cholesterol, Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL) were measured at baseline and the end of the study and weight, waist circumference, Body Mass Index (BMI) were measured at baseline, middle and end of the study. Independent t-test was used for comparing the baseline and mean changes. The variables that measured in three times were compared using repeated measurement test between two groups. Paired t-test was performed to compare within group differences. Results: Serum triglyceride, FBS, weight and systolic blood pressure decreased and serum HDL increased compared to the placebo group. There were no significant changes in serum cholesterol, LDL, BMI, waist circumference and diastolic blood pressure after omega-3 administration. Conclusion: Omega-3 supplementation for 12 weeks improves some of the indicators of metabolic syndrome in individuals with ischemic heart disease. (IRCT Code: IRCT20190819044563N1).

Sign in / Sign up

Export Citation Format

Share Document