scholarly journals Dietary Supplementation with Biobran/MGN-3 Increases Innate Resistance and Reduces the Incidence of Influenza-like Illnesses in Elderly Subjects: A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 4133
Author(s):  
Ahmed F. Elsaid ◽  
Sudhanshu Agrawal ◽  
Anshu Agrawal ◽  
Mamdooh Ghoneum
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Natural Killer ◽  
Cell Activity ◽  
Incidence Density ◽  
Elderly Subjects ◽  
Epithelial Tissue ◽  
Nk Activity ◽  
Double Blind ◽  
Double Blind Placebo

Influenza-like illness (ILI) remains a major cause of severe mortality and morbidity in the elderly. Aging is associated with a decreased ability to sense pathogens and mount effective innate and adaptive immune responses, thus mandating the development of protective nutraceuticals. Biobran/MGN-3, an arabinoxylan from rice bran, has potent anti-aging and immunomodulatory effects, suggesting that it may be effective against ILI. The objective of the current study was to investigate the effect of Biobran/MGN-3 on ILI incidence, natural killer (NK) cell activity, and the expressions of RIG-1 (retinoic acid-inducible gene 1), MDA5 (melanoma differentiation-associated protein 5), and their downstream signaling genes ISG-15 (interferon-stimulated genes 15) and MX1 (myxovirus (influenza) resistance 1, interferon-inducible). A double-blind, placebo-controlled clinical trial included eighty healthy older adults over 55 years old, 40 males and 40 females, who received either a placebo or Biobran/MGN-3 (500 mg/day) for 3 months during known ILI seasonality (peak incidence) in Egypt. The incidence of ILI was confirmed clinically according to the WHO case definition criteria. Hematological, hepatic, and renal parameters were assessed in all subjects, while the activity of NK and NKT (natural killer T) cells was assessed in six randomly chosen subjects in each group by the degranulation assay. The effect of Biobran/MGN-3 on RIG-1 and MDA5, as well as downstream ISG15 and MX1, was assessed in BEAS-2B pulmonary epithelial cells using flow cytometry. The incidence rate and incidence density of ILI in the Biobran/MGN-3 group were 5.0% and 0.57 cases per 1000 person-days, respectively, compared to 22.5% and 2.95 cases per 1000 person-days in the placebo group. Furthermore, Biobran/MGN-3 ingestion significantly enhanced NK activity compared to the basal levels and to the placebo group. In addition, Biobran/MGN-3 significantly upregulated the expression levels of RIG-1, MDA5, ISG15, and MX1 in the human pulmonary epithelial BEAS-2B cell lines. No side effects were observed. Taken together, Biobran/MGN-3 supplementation enhanced the innate immune response of elderly subjects by upregulating the NK activity associated with reduction of ILI incidence. It also upregulated the intracellular RIG-1, MDA5, ISG15, and MX1 expression in pulmonary epithelial tissue cultures. Biobran/MGN-3 could be a novel agent with prophylactic effects against a wide spectrum of respiratory viral infections that warrants further investigation.

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 Daily intake of Lactobacillus casei Shirota increases natural killer cell activity in smokers

2011 ◽  
Vol 108 (2) ◽  
pp. 308-314 ◽  
Author(s):  
Marcella Reale ◽  
Paolo Boscolo ◽  
Veronica Bellante ◽  
Chiara Tarantelli ◽  
Marta Di Nicola ◽  
...  
Keyword(s):  
Cytotoxic Activity ◽  
Natural Killer ◽  
Lactobacillus Casei ◽  
Mononuclear Cells ◽  
Natural Killer Cell Activity ◽  
Killer Cell ◽  
Daily Intake ◽  
Cell Activity ◽  
Nk Activity ◽  
Double Blind

Dietary probiotics supplementation exerts beneficial health effects. Since cigarette smoking reduces natural killer (NK) activity, we evaluated the effect of Lactobacillus casei Shirota (LcS) intake on NK cytotoxic activity in male smokers. The double-blind, placebo-controlled, randomised study was conducted on seventy-two healthy Italian blue-collar male smokers randomly divided for daily intake of LcS powder or placebo. Before and after 3 weeks of intake, peripheral blood mononuclear cells were isolated and NK activity and CD16+ cells' number were assessed. Daily LcS intake for 3 weeks significantly increased NK activity (P < 0·001). The increase in NK activity was paralleled by an increase in CD16+ cells (P < 0·001). Before intake, NK cytotoxic activity inversely correlated with the number of cigarettes smoked (R − 0·064). LcS intake prevented the smoke-dependent expected NK activity reduction. The analysis of the distribution of changes in smoke-adjusted NK activity demonstrated that the positive variations were significantly associated with LcS intake, while the negative variations were associated with placebo intake (median value of distributions of differences, 20·98 lytic unit (LU)/107 cells for LcS v. − 4·38 LU/107 cells for placebo, P = 0·039). In conclusion, 3 weeks of daily LcS intake in Italian male smokers was associated with a higher increase in cytotoxic activity and CD16+ cells' number in comparison to the placebo intake group.

scholarly journals Efficacy of Matricaria chamomilla L. in Infantile Colic: A Double Blind, Placebo Controlled Randomized Trial

2020 ◽  
pp. 1-11
Author(s):  
Fatemeh Mohamadi Sorme ◽  
Malihe Tabarra ◽  
Hosein Alimadady ◽  
Roja Rahimi ◽  
Mahdi Sepidarkish ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Infantile Colic ◽  
Matricaria Chamomilla ◽  
Double Blind ◽  
Serious Adverse Event ◽  
Double Blind Placebo ◽  
Common Problems ◽  
To Receive ◽  
Delivery Type

Objective: Infantile colic is one of the most common problems in neonatal and early infancy, the prevalence of which has been reported as 10-20%. The present clinical trial was conducted to investigate whether topical use of chamomile oil reduces crying and fussing in breastfed colicky infants. Methods: A total of 102 breastfed colicky infants were divided into two groups to receive topical chamomile or placebo oil 6 times a day for 7 days. Both groups also received 5 mg of Simethicone syrup 4 times a day. Parents reported on crying and fussing duration, exertion times and side effects using a questionnaire. Results: 90 babies could complete the trial including 47 patients in chamomile group and 43 patients in the placebo group. Babies in both groups were the same in terms of gestational age, birth weight, birth order, gender, delivery type, crying and fussing on the day before the treatment. At the end of the study, crying and fussing was found to be lower in chamomile group than the placebo group (p <0.001). Also, 39 and 27 patients responded to the treatment in chamomile and placebo groups respectively. The effect of chamomile oil on crying (p<0.01) and fussing (p< 0.001) was significant. No serious adverse event was reported. Conclusion: Results revealed that chamomile oil reduced symptoms in breastfed colicky infants compared to the infants in the placebo group. This suggests that topical use of chamomile oil may be effective in the treatment of colic.

scholarly journals Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients—a double-blind, placebo-controlled, clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anurag Srivastava ◽  
Manickavasagam Rengaraju ◽  
Saurabh Srivastava ◽  
Vimal Narayanan ◽  
Vivek Gupta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Viral Load ◽  
Adverse Events ◽  
Hospital Stay ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Function Test ◽  
Stay Time ◽  
The Mean

Abstract Background and aim Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medicines, especially polyherbal formulations like Nilavembu Kudineer (NVK) and Kaba Sura Kudineer (KSK) of the Siddha system of medicine, have been used as public health interventions for controlling viral epidemics like dengue and Chikungunya. These traditional therapies have been found safe, effective, and widely accepted. The current study evaluates the comparative efficacy of NVK and KSK as opposed to the placebo, in the management of mild to moderate COVID-19 disease. Methods The study was a double-blind, placebo-controlled comparative clinical trial, with the primary objective of determining the efficacy of KSK and NVK. Patients (n=125) diagnosed with mild to moderate COVID-19 symptoms were enrolled in the study over a period of 4 months (Aug 2020—Dec 2020). Participants were randomized into 3 arms; placebo-decaffeinated tea in Arm I, NVK in Arm II, and KSK in Arm III. Each arm received 60 ml of the respective treatment twice a day, post morning and evening meals, along with standard allopathy treatment for a maximum of 10 days. The main outcome measures of the study were the reduction in SARS-CoV-2 viral load, hospital stay, and time taken by the patients to become asymptomatic from symptomatic. Efficacy assessments included clinical symptoms (fever, cough, and breathlessness) each day and real-time reverse transcription-polymerase chain reaction (RT-PCR), liver function test (LFT), renal function test (RFT), and electrolytes and electrocardiogram (ECG) at baseline (day 0) and days 3, 6, and 10. Post-treatment, participants were followed up for 30 days via phone for adverse effects if any. Effects of drugs on inflammatory markers (IL6) at the end of treatment were also recorded. Adverse events (AE) were monitored throughout the study. Results The results revealed that when compared to patients in the placebo arm, those in NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and the time taken to become symptomatic from asymptomatic. Out of 125 COVID-19 patients recruited, 120 completed the study; two from the placebo group developed severe symptoms and were shifted to the intensive care unit (ICU) and three patients from Arms II and III withdrew from the study. The mean age of females (n=60) and males (n=60) enrolled was between 40.2 and 44.3 years, respectively. Results were more promising for all the patients in NVK and KSK arms as all enrolled participants (100%) under this group got discharged by day 6 as compared to only 42.5% (n=17) from the placebo group on that day. The hospital stay time for patients in Arm I was significantly longer (mean [SD]=8.4 [2.0] days) as compared to the Arms II and III (mean [SD]=4.7 [1.5] and 4.2 [1.5] days, respectively (Kruskal-Wallis test, P=0.0001). Patients in the three groups took a significantly different number of days to become asymptomatic. While Arm II and III patients took mean of 2.5 and 1.7 days, respectively, Arm I, patients took a mean of 4.2 days (Kruskal-Wallis test, P=0.0001). In all, two adverse events were recorded, one for vomiting and one for diarrhea lasting a day in Arm I and Arm II, respectively. The mean value of interleukin-6 (IL6) was significantly different in comparison to the placebo-decaffeinated tea arm (NVK=2.6 and KSK=2.2, placebo=4.0, P=0.02). The other blood biochemical parameters like C-reactive protein (CRP), lactate dehydrogenase (LDH), ferritin, and D-dimer that were analyzed at the baseline and at the time of discharge from the hospital, were not significantly different in the three arms. Conclusion NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and time taken for patients to become asymptomatic from symptomatic, when compared to the placebo (decaffeinated tea). The primary outcome measures of the KSK arm were significantly better than those in the NVK arm.

Evaluation of a nutritional supplement for the alleviation of pain associated with feline degenerative joint disease: a prospective, randomized, stratified, double-blind, placebo-controlled clinical trial

2021 ◽  
pp. 1098612X2110534
Author(s):  
Rachael Cunningham ◽  
Margaret E Gruen ◽  
Andrea Thomson ◽  
B Duncan X Lascelles
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Chondroitin Sulfate ◽  
Outcome Measures ◽  
Nutritional Supplement ◽  
Degenerative Joint Disease ◽  
Joint Disease ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

Objectives The purpose of this study was to evaluate the pain-alleviating and activity-enhancing effects of glucosamine/chondroitin sulfate (Dasuquin) in cats that had degenerative joint disease (DJD) and owner-noted mobility/activity impairment. We hypothesized that the nutritional supplement would produce pain-relieving and activity-enhancing effects in cats with painful DJD. Methods In this prospective, randomized, stratified, double-blind, placebo-controlled clinical trial, 59 cats with DJD pain were assigned to receive a placebo (n = 30) or supplement (n = 29) for 6 weeks after 2 weeks of placebo. Outcome measures (at-home accelerometry and client-specific outcome measures [feline (CSOMf); Feline Musculoskeletal Pain Index (FMPI); quality of life (QoL)]; and veterinarian examination) were collected at days 14, 28, 42 and 56. Results Twenty-seven cats in the treatment group and 30 in the placebo group completed the trial. Within the first 2 weeks (placebo administration to all cats), 78% of all cats had an improvement in CSOMf scores. Both groups showed significant improvement at most time points in CSOMf, FMPI, QoL and pain scores, with the placebo group showing greater improvement than the supplement group (significant for CSOMf [ P = 0.01]). Overall, no differences in activity were seen between the groups. Cumulative distribution function analysis indicated that for most levels of activity, the placebo-treated cats were more active; however, the least active cats were more active on the supplement ( P = 0.013). Conclusions and relevance This study showed a strong placebo effect. The glucosamine/chondroitin sulfate supplement did not show pain-relieving effects when compared with placebo.

scholarly journals A Clinical Trial to Investigate the Effect of Cynatine HNS on Hair and Nail Parameters

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Christina Beer ◽  
Simon Wood ◽  
Robert H. Veghte
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Amino Acid ◽  
Hair Loss ◽  
Hair Growth ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
End Points ◽  
Double Blind Placebo ◽  
New Novel

Objective. A new, novel product, Cynatine HNS, was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized, double-blind, placebo-controlled clinical trial.Methods. A total of 50 females were included and randomized into two groups. The active group (n=25) received 2 capsules containing Cynatine HNS, comprised of Cynatine brand keratin (500 mg) plus vitamins and minerals, per day, and the placebo group (n=25) received 2 identical capsules of maltodextrin per day for 90 days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured. End points were also measured for nail strength and the appearance of nails.Results. The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo.Conclusion. Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less. EudraCT number is 2014-002645-22.

scholarly journals Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Lei Shen ◽  
Si Ra Gwak ◽  
Jong Cheon Joo ◽  
Bong Keun Song ◽  
Seon Woo Cha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Panax Ginseng ◽  
Hepatic Dysfunction ◽  
Controlled Clinical Trial ◽  
Gamma Glutamyl Transferase ◽  
Double Blind ◽  
Ginseng Extract ◽  
Double Blind Placebo ◽  
Glutamyl Transferase

Background. The purpose of this study was to evaluate the efficacy and safety of Panax ginseng extract (GS-KG9) in the treatment of hepatic dysfunction. Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted from December 2017 to January 2019. The trial included 60 subjects between the ages of 19 and 70 who had higher alanine transaminase (ALT) levels than the normal upper limit. The subjects were randomly divided into two groups: GS-KG9 (n = 30) and placebo (n = 30). The former was administered three GS-KG9 capsules (3 g/day) and the latter three placebo capsules (3 g/day) twice each day orally after meals in the morning and evening for 12 weeks. The primary goal was to observe the changes in ALT and gamma-glutamyl transferase (GGT) levels. The safety of the treatment was assessed and adverse events (AEs) were recorded. Results. Out of 60 subjects, nine were excluded from the efficacy analysis because they met the exclusion criteria. Therefore, a total of 51 subjects were evaluated for the effectiveness of the treatment (26 in the GS-KG9 group and 25 in the placebo group). After 12 weeks of treatment, the ALT levels were significantly reduced in the GS-KG9 group compared to the placebo group (p=0.009). The GGT level of the GS-KG9 group was significantly lower than that of the placebo group (p=0.036). Mild AEs, such as diarrhea, occurred during the study. There were no significant differences between the two groups. Conclusion. The results of this trial suggest that GS-KG9 might be an effective and safe option for mild hepatic dysfunction. This trial is registered with KCT0004080.

scholarly journals Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Homoeopathic Arnica C30 for Pain and Infection after Total Abdominal Hysterectomy

1997 ◽  
Vol 90 (2) ◽  
pp. 73-78 ◽  
Author(s):  
Oliver Hart ◽  
Mark A Mullee ◽  
George Lewith ◽  
John Miller
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Total Abdominal Hysterectomy ◽  
Abdominal Hysterectomy ◽  
Postoperative Recovery ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Significant Difference

Homoeopathic potencies of arnica have been used for many years to aid postoperative recovery. The effects of arnica C30 on pain and postoperative recovery after total abdominal hysterectomy were evaluated in a double-blind, randomized, controlled study. Of 93 women entered into the study, 20 did not complete protocol treatment: nine were excluded because they failed to comply with the protocol, nine had their operations cancelled or changed within 24 h and two had to be withdrawn because of the recurrence of previously chronic painful conditions. Those who did not complete protocol treatment were equally divided between the arnica (nine patients) and placebo groups (11 patients). 73 patients completed the study, of whom 35 received placebo and 38 received arnica C30. The placebo group had a greater median age and the arnica group had slightly longer operations; nevertheless, no significant difference between the two groups could be demonstrated. We conclude that arnica in homoeopathic potency had no effect on postoperative recovery in the context of our study.

Double-Blind, Placebo-Controlled, Randomized Clinical Trial of the Effect of the Dietary Supplement S-Adenosyl-L-Methionine (AdoMet) on Plasma Homocysteine (Hcy) Levels in Healthy Human Subjects.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1481-1481
Author(s):  
Michael A. Thompson ◽  
Brent A. Bauer ◽  
Laura L. Loehrer ◽  
Stephen S. Cha ◽  
Jayawant N. Mandrekar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Randomized Clinical Trial ◽  
Primary Endpoint ◽  
Human Subjects ◽  
Nutritional Supplement ◽  
Healthy Human ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Human Subjects

Abstract BACKGROUND: S-adenosyl-L-methionine (AdoMet or SAM-e®) is a commonly used nutritional supplement available in the United States since 1999. AdoMet is metabolized to homocysteine (Hcy), a potential cardiovascular risk factor. A few open-label, single-arm studies have reported on the effect of exogenous AdoMet on the levels of Hcy in humans; however, this has not been tested in a double-blind, randomized clinical trial. As a nutritional supplement, AdoMet is subject only to limited regulation by the FDA, despite being used to treat clinical diseases such as depression and osteoarthritis. AdoMet is the methyl donor for small molecule, DNA, RNA, and protein methylation reactions; therefore, further understanding the biology of the AdoMet/Hcy system is important. We hypothesized that exogenous AdoMet would increase plasma Hcy levels. METHODS: In a double-blind, placebo-controlled, randomized clinical trial, 93 healthy human subjects were screened and 52 were treated with placebo (26) or 800 mg per day AdoMet (26) pills for 4 weeks. Pre- and post-treatment Hcy levels were measured. The primary endpoint was change in Hcy level. Secondary endpoints included an interim Hcy level, high sensitivity C-reactive protein (hsCRP) levels, lipid profile, and transaminases. Exclusion criteria included pregnancy and concurrent use of medications associated with changes in Hcy. RESULTS: Of 52 subjects enrolled, 45 were evaluable at the end of treatment. Subject characteristics and dropout rates were similar between placebo and control groups. Adverse events were minor and were not different between placebo and AdoMet. The primary endpoint, change in Hcy, was not significantly different between the groups (mean (umol/L), baseline: 7.43 (placebo), 8.25 (AdoMet), P=0.358; 4 week: 7.66 (placebo), 8.06 (AdoMet), P = 0.683; Baseline − 4 week: 0.23 (placebo), −0.19 (AdoMet), P = 0.427). No statistically significant difference in change in Hcy or hsCRP at 2 or 4 weeks was noted. This was true for both absolute differences as well as relative percent changes. A small decrease in ALT was observed at 2 weeks in the AdoMet group compared to the placebo group (P = 0.027). AdoMet is used in the treatment of liver diseases. There was a small, but statistically significant (P = 0.028) decrease in total cholesterol in the AdoMet group as compared to the placebo group. Interestingly, a subject with the highest baseline Hcy level had a decline in Hcy on AdoMet. Study limitations include no evaluation of AdoMet serum levels or measurement of the effect of AdoMet on DNA methylation patterns. CONCLUSIONS: AdoMet seems well tolerated and in a dose of 800 mg/day for 4 weeks does not appear to significantly affect Hcy levels in the blood. Future clinical trials of AdoMet should monitor Hcy levels with extended use of AdoMet to confirm its safety with long term use. Clinicaltrials.gov ID: NCT00284011.

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