scholarly journals A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Kathy Musa-Veloso ◽  
Lina Paulionis ◽  
Tetyana Pelipyagina ◽  
Mal Evans
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Protein Hydrolysate ◽  
Office Blood Pressure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
Significant Difference

In this randomized, double-blind, placebo-controlled, multicentre, parallel, 8-week study, the efficacy of a daily dose of 1200 mg of protein hydrolysate from Coldwater Shrimp (Pandalus borealis) on ambulatory and office blood pressure was investigated in 144 free-living adults with mild to moderate hypertension. The primary outcomes of the study were daytime ambulatory systolic blood pressure and office blood pressure. During the 8-week intervention period and in the intention-to-treat analysis (n=144), there were significant reductions in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group in daytime ambulatory systolic blood pressure at 4 weeks (p=0.014) and at 8 weeks (p=0.002), and in office systolic blood pressure at 2 weeks (p=0.031) and 4 weeks (p=0.010), with a trend toward significance at 8 weeks (p=0.087). By 8 weeks, significant and favourable improvements in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group were also observed for several secondary outcomes, including 24-hour ambulatory systolic and diastolic blood pressure, daytime ambulatory diastolic blood pressure, and daytime and 24-hour ambulatory mean arterial pressure. Also by Week 8, there was a statistically significant difference between groups in the distribution of subjects across National Institutes of Health-defined blood pressure categories (i.e., Normotensive, Prehypertensive, Stage 1 hypertension, and Stage 2 hypertension), with a more favourable distribution in the shrimp-derived protein hydrolysate group than in the placebo group (p=0.006). Based on exploratory analyses conducted only in participants in the shrimp-derived protein hydrolysate group, angiotensin II levels were significantly reduced relative to baseline. This study is registered at ClinicalTrials.gov NCT01974570.

scholarly journals Effects of the consumption of proanthocyanidins derived from acacia bark on blood pressure in healthy Japanese adults: A randomized, double-blind, placebo-controlled, parallel-group comparison study

2021 ◽  
Vol 11 (7) ◽  
pp. 310
Author(s):  
Asami Baba ◽  
Tomohiro Hoshino ◽  
Sosuke Ogawa ◽  
Tsuyoshi Takara
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Bark Extract ◽  
Comparison Study ◽  
Japanese Adult ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Japanese Adults

Objective: The aim of this study is to verify the effects of consuming proanthocyanidins derived from acacia bark on improving blood pressure and blood circulation in healthy Japanese adult subjects. Methods: This was a randomized, double-blind, placebo-controlled, parallel-comparison study involving 66 healthy Japanese adults. Subjects were allocated into either acacia or placebo group (n = 33 each) using a random number generator. Subjects consumed six tablets/day of either acacia bark extract tablets or placebo for 12 weeks. The primary outcome was the measured value of sitting systolic blood pressure at 12 weeks, whereas the secondary outcomes were sitting systolic and diastolic blood pressures, superoxide dismutase activity in blood, and blood flow.Results: The number of subjects analyzed as full analysis set was 33 (20 men and 13 women) in the Acacia group and 31 (23 men and 8 women) in the placebo group. Compared with the placebo group, the measured values and changes from baseline at 4, 8, and 12 weeks of the sitting systolic blood pressure were significantly lower in the Acacia group. Furthermore, “the ratio of the number of subjects whose sitting systolic blood pressure <130 mmHg and diastolic blood pressure ≤89 mmHg at 12 weeks” of the Acacia group was significantly higher than that of the placebo group. No adverse event was observed. Conclusions: Proanthocyanidins derived from acacia bark showed a hypotensive effect. Trial registration: UMIN-CTR: UMIN000039416. Foundation: Acacia-No-Ki Co., Ltd. Keywords: Acacia bark extract, Proanthocyanidins, Systolic blood pressure, Diastolic blood pressure

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 A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis

2019 ◽  
Vol 41 (4) ◽  
pp. 492-500
Author(s):  
Christine Zomer Zomer Dal Molin ◽  
Thiago Mamoru Sakae ◽  
Fabiana Schuelter-Trevisol ◽  
Daisson Jose Trevisol
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Major Complication ◽  
Number Needed To Treat ◽  
Intradialytic Hypotension ◽  
Double Blind ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Two Phases ◽  
Intradialytic Symptoms

Abstract Introduction: Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality. Objective: To study the effects of sertraline to prevent IDH in hemodialysis patients. Methods: This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension. Results: Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms. Conclusion: This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.

A comparison of CAT Doppler and oscillometric Memoprint machines for non-invasive blood pressure measurement in conscious cats

2005 ◽  
Vol 7 (3) ◽  
pp. 147-152 ◽  
Author(s):  
Rosanne E. Jepson ◽  
Vivien Hartley ◽  
Michael Mendl ◽  
Sarah ME Caney ◽  
David J Gould
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Blood Pressure Measurement ◽  
Systemic Hypertension ◽  
Pressure Measurements ◽  
Non Invasive ◽  
Measuring Devices ◽  
Oscillometric Device ◽  
Significant Difference

Indirect blood pressure measurements were compared in 28 conscious cats using Doppler and oscillometric blood pressure-measuring devices. Ten cats were used to compare Doppler measurements between two examiners and 18 cats were used to compare Doppler and oscillometric measurements. The Doppler machine obtained systolic and diastolic blood pressure readings in 100% and 51% of attempts, respectively. With the oscillometric machine, systolic and diastolic blood pressure readings were obtained in 52% of the attempts. With the Doppler, measures of mean systolic blood pressure between two examiners were positively correlated, but there was no correlation for diastolic blood pressure measures. When comparing the results obtained by Doppler and oscillometric machines there was no significant difference between mean systolic blood pressure readings, but the oscillometric machine produced significantly higher estimates of diastolic blood pressure. In both cases, the standard deviations for the oscillometric machine were considerably larger than those for the Doppler machine. The first reading of systolic blood pressure obtained with the Doppler machine was an excellent predictor of the mean of five readings, but this was not so for the oscillometric machine. It took less than 5 min to obtain five readings in 37.5% of cases with the Doppler machine but this was true for only 5% of cases with the oscillometric machine. Two cats with ophthalmological lesions consistent with systemic hypertension were identified. In these two patients, systolic blood pressure measurements were between 200 and 225 mmHg when measured by Doppler, and between 140 and 150 mmHg when measured by the oscillometric machine. This suggests that a lower reference range for normal systolic blood pressure values should be used for the oscillometric device.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Analisis Efektivitas Kontrol Penurunan Tekanan Darah pada Pasien Hipertensi yang Mendapat Terapi Obat Antihipertensi Golongan Angiotensin Receptor Blocker’s (Candersartan, Valsartan, Kalium Losartan)

2017 ◽  
Vol 2 (2) ◽  
pp. 9-14
Author(s):  
Ninik Mas Ulfa
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Therapy Group ◽  
Age Factors ◽  
Blood Pressure Reduction ◽  
Hypertensive Patients ◽  
Significant Difference ◽  
Group A ◽  
Group B

ABSTRAKHipertensi adalah peningkatan tekanan darah sistolik lebih dari 140 mmHg dan tekanan darah diastolik lebih dari 90 mmHg pada dua kali pengukuran dengan selang waktu lima menit dalam keadaan cukup istirahat. Faktor penyebab hipertensi adalah faktor gaya hidup, faktor genetika dan faktor usia. Hipertensi termasuk dalam penyakit degeneratif dimana terjadi penurunan organ tubuh. Tujuan dari penelitian ini adalah untuk mengetahui efektifitas kontrol penurunan teakanan darah dari terapi obat Candersartan, Valsartan dan Kalium Losartan. Pada penelitian ini dilakukan di RS X wilayah Surabaya Selatan dan RS Y wilayah Surabaya Timur. Penelitian ini bersifat retrospektif dengan pengamatan observasioanl. Penelitian ini terbagi dalam 3 kelompok terapi dengan jumlah total populasi adalah 57 pasien. Data tekanan darah sistolik-diastolik diamati selama 5 bulan terapi darimasing-masing kelompok terapi A (Candersartan n = 19), kelompok terapi B (Valsartan n= 19), dan kelompok terapi C (Kalium Losartan n= 19).Hasil penelitian menunjukkan bahwa terjadi penurunan tekanan darah sistolik pada kelompok A sebesar 21,18%, kelompok B = 24,20%, dan kelompok C = 22,51%. Penurunan tekanan darah diastolic pada kelompok A sebesar 12,14%, kelompok B = 14,04% dan kelompok C = 10,98%. Berdasarkan hasil analisa statistik diperoleh hasil p = 0,967 > α = 0,05 yang berarti tidak ada perbedaan yang bermakna dari ketiga kelompok terapi tersebut dalam penurunan tekanan darah sistolik maupun diastolik pada pasien hipertensi. Hal ini berarti bahwa efektifitas ketiga obat tersebut dalam kontrol penurunan tekanan darah pada pasien Hipertensi mempunyai efektifitas yangKata Kunci: Candersartan, Valsartan, Kalium Losartan, HipertensiABSTRACTHypertension is an increase in systolic blood pressure of more than 140 mmHg and diastolic blood pressure of more than 90 mmHg in two measurements with an interval of five minutes in a resting state. Factors causing hypertension are lifestyle factors, genetic factors and age factors. Hypertension is included in degenerative diseases where there is a decrease in body organs. The purpose of this study was to determine the effectiveness of blood pressure control of Candersartan, Valsartan and Potassium Losartan. This research was conducted in RS X of South Surabaya and RS Y of East Surabaya. This study is retrospective with observational. The study was divided into 3 therapeutic groups with a total population of 57 patients. Data on systolic-diastolic blood pressurewere observed for 5 months of therapy from each of the therapy groups A (Candersartan n = 19), therapy group B (Valsartan n = 19), and therapy group C (Potassium Losartan n = 19). That there was a decrease in systolic blood pressure in group A of 21,18%, group B = 24,20%, and group C = 22,51%. Diastolic blood pressure decrease in group A was 12,14%, group B = 14,04% and group C = 10,98%. Based on the results of statistical analysis obtained results p = 0.967> α = 0.05 which means there is no significant difference of the three groups of therapy in the reduction of systolic blood pressure and diastolic in hypertensive patients. This means that the effectiveness of the three drugs in the control of blood pressure reduction in hypertensive patients has the same effectiveness.Key Words: Candersartan, Valsartan, Potasium Losartan, Hypertesion

scholarly journals Cardiovascular Changes in Smoker and Nonsmoker Male Stroke Patients

2010 ◽  
Vol 14 (Number 1) ◽  
pp. 32-35
Author(s):  
N Habib ◽  
Md. R Amin ◽  
US N Begum ◽  
N Akhter ◽  
D Akther ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Descriptive Study ◽  
Stroke Patients ◽  
Medical College ◽  
Significant Difference ◽  
Group A ◽  
Altered Physiology ◽  
Group B

This descriptive study was done in the Deponment of Physiology. Dhaka Medical College, Dhaka. during the period of January 2008 to December 2008. The objective of the study was to measure pulse and blood pressure in smokers and nonsmoker adult male stroke patients and to find out changes in pulse and blood pressure among the smoker and non-smoker stroke patients. To accomplish this purpose 105 patient of over 20 years of age were selected. They were divided into two groups: Group A consisting of thirty n on-smoker and group B consisting of seven,' five smoker stroke patients. The finding showed that smoking caused no statistical significant difference 1p>0.05) in pulse and systolic blood pressure among she groups. Diastolic blood pressure was significantly higher (p<0.05) fill smokers than non-smokers. The study therefore provides the scope to understand the altered physiology of smoker stroke pollen's.

The Effect of Vitamin D Supplement Consumption on Premenstrual Syndrome in Vitamin D-Deficient Young Girls: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2019 ◽  
Vol 26 (5) ◽  
pp. 336-342 ◽  
Author(s):  
Reihaneh Abdollahi ◽  
Behnaz Abiri ◽  
Parvin Sarbakhsh ◽  
Maryam Kashanian ◽  
Mohammadreza Vafa
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Premenstrual Syndrome ◽  
Physical Symptoms ◽  
Activity Level ◽  
Double Blind ◽  
Premenstrual Symptoms ◽  
Double Blind Placebo ◽  
Young Girls ◽  
Significant Difference

Background: Premenstrual syndrome (PMS) alludes to a cyclic advent of somatic and psychiatric symptoms that affect some women of reproductive age. Some studies demonstrated that vitamin D was associated with premenstrual symptoms. Objective: The aim of this study was to evaluate the effect of vitamin D supplementation in the treatment of PMS in vitamin D-deficient young girls. Methods: In this randomized double-blind placebo-controlled trial, 130 vitamin D-deficient girls aged 18–30 years, with PMS, were randomly divided into 2 groups and received a 2,000 IU vitamin D tablet (n = 64) or a placebo (n = 66) every other day for 12 weeks. At the beginning and at the end of week 12, serum 25(OH)-D, premenstrual symptoms, anthropometric indices, dietary intake, physical activity level, and sun exposure were evaluated. Statistical analysis was performed using SPSS version 20. p < 0.05 was considered statistically significant. Results: Serum 25(OH)-D levels were significantly elevated in the vitamin D group in comparison to the placebo group after 12 weeks (p < 0.001). There was no significant difference between the 2 groups with regard to 14 symptoms of PMS after 12 weeks of intervention, even after adjustment for the baseline values of anxiety, weeping, and hypersomnia (for all symptoms, p > 0.05). However, in the vitamin D group, scores of nervousness (p < 0.001), job activity reduction (p = 0.01), social activity reduction (p = 0.01), fatigue (p < 0.001), and physical symptoms (p = 0.00) were reduced at the end of the intervention, and these changes were statistically significant compared to baseline. However, these alterations did not reach significance compared with the placebo group (p > 0.05). Conclusion: It seems that 2,000 IU vitamin D consumption in the vitamin D-deficient young girls with PMS every other day for 12 weeks had no significant impact on other PMS symptoms.

scholarly journals Antihypertensive effect of casein hydrolysate in a placebo-controlled study in subjects with high-normal blood pressure and mild hypertension

2005 ◽  
Vol 94 (1) ◽  
pp. 84-91 ◽  
Author(s):  
Seiichi Mizuno ◽  
Keiichi Matsuura ◽  
Takanobu Gotou ◽  
Shingo Nishimura ◽  
Osami Kajimoto ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Antihypertensive Effect ◽  
Mild Hypertension ◽  
Casein Hydrolysate ◽  
Normal Blood ◽  
Controlled Study ◽  
Normal Blood Pressure

We describe a clinical trial to study the efficacy of a casein hydrolysate, prepared using an Aspergillus oryzae protease, containing the major angiotensin-I-converting enzyme inhibitory peptides Val-Pro-Pro (VPP) and Ile-Pro-Pro (IPP) in a single-blind, placebo-controlled study. A total of 131 volunteers with high-normal blood pressure and mild hypertension were randomly divided into four groups (n 32 or 33 in each group). Each volunteer was given two tablets containing four different dosages of VPP and IPP (VPP+IPP: 0, 1·8, 2·5 and 3·6 mg), daily for 6 weeks. A significant decrease in systolic blood pressure was observed at 6 weeks in the active group receiving 1·8 mg (P<0·01) VPP and IPP; in the active groups receiving either 2·5 mg or 3·6 mg, systolic blood pressure was decreased at both 3 weeks (P<0·05 and P<0·05) and 6 weeks (P<0·001 and P<0·0001) compared with systolic blood pressure measured before treatment. Changes in the systolic blood pressure after 6 weeks of treatment in the four groups were −1·7, −6·3, −6·7 and −10·1 mmHg, and these effects were dose dependent. In addition, a significant difference in systolic blood pressure between the placebo group and the VPP and IPP group receiving 3·6 mg was observed (P<0·001) by two-way ANOVA. The antihypertensive effect was greater in mildly hypertensive subjects (n 20 or 21 in each group) than in any of the other subjects. No significant change of diastolic blood pressure was observed for all the test groups, and no differences in diastolic blood pressure in the test sample groups compared with the placebo group were observed during the test period.

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