Effects of folic acid on renal endothelial function in patients with diabetic nephropathy: results from a randomized trial

2014 ◽  
Vol 127 (7) ◽  
pp. 499-505 ◽  
Author(s):  
Markus P. Schneider ◽  
Andreas Schneider ◽  
Agnes Jumar ◽  
Iris Kistner ◽  
Christian Ott ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Nephropathy ◽  
Folic Acid ◽  
Human Subjects ◽  
Oxidant Stress ◽  
Treatment Options ◽  
High Dose ◽  
Double Blind ◽  
Novel Treatment ◽  
Incipient Diabetic Nephropathy

Despite encouraging pre-clinical data, this double-blind randomized clinical trial demonstrates that treatment with high-dose folic acid fails to reduce oxidant stress and albuminuria in human subjects with incipient diabetic nephropathy. Novel treatment options for this condition are urgently needed.

Ultrasound-Guided Injection of Dextrose Versus Corticosteroid in Chronic Plantar Fasciitis Management: A Randomized, Double-Blind Clinical Trial

2021 ◽  
pp. 193864002098092
Author(s):  
Gholamreza Raissi ◽  
Amin Arbabi ◽  
Maryam Rafiei ◽  
Bijan Forogh ◽  
Arash Babaei-Ghazani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Plantar Fasciitis ◽  
Rating Scale ◽  
Corticosteroid Injection ◽  
Treatment Options ◽  
Plantar Fascia ◽  
Numeric Rating Scale ◽  
Therapeutic Effects ◽  
Ultrasound Guided ◽  
Double Blind

Design Chronic plantar fasciitis (PF) is a common cause of chronic heel pain, with different conventional treatment options. In this randomized clinical trial, the effect of ultrasound-guided injection of dextrose versus corticosteroid in chronic PF was evaluated and compared. Methods A total of 44 patients suffering from chronic PF who visited the physical medicine and rehabilitation clinic were enrolled in the study. Two table-randomized groups were formed. They received an ultrasonography-guided, single injection of either 40 mg methylprednisolone or 20% dextrose. Numeric Rating Scale (NRS), Foot and Ankle Ability Measure questionnaire with 2 subscales, Activities of Daily Living (FAAM-A) and Sports (FAAM-S), along with ultrasonographic parameters were evaluated before and at 2 and 12 weeks after the injection. Results. A total of 40 participants completed the study. Both interventions significantly improved pain and function at 2 and 12 weeks postinjection. After 2 weeks, compared with the dextrose prolotherapy, the corticosteroid group had significantly lower daytime and morning NRS scores (2.55 vs 4.1, P = .012, and 2.75 vs 4.65, P = .004), higher FAAM-S (66.84 vs 54.19; P = .047), and lower plantar fascia thickness at insertion and 1 cm distal to the insertion zone (3.89 vs 4.29 mm, P = .004, and 3.13 vs 3.48 mm, P = .002), whereas FAAM-A was similar in both groups ( P = .219). After 12 weeks, all study variables were statistically similar between corticosteroid and dextrose prolotherapy groups. No injection-related side effects were recorded in either group. Conclusion Both methods are effective. Compared with dextrose prolotherapy, our results show that corticosteroid injection may have superior therapeutic effects early after injection, accompanied by a similar outcome at 12 weeks postinjection. Levels of Evidence: Level II

Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

2021 ◽  
pp. 088506662110388
Author(s):  
Divya Birudaraju ◽  
Sajad Hamal ◽  
John A. Tayek
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Adrenocorticotropic Hormone ◽  
Serum Cortisol ◽  
High Dose ◽  
Cortisol Response ◽  
Acth Stimulation ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

The effects of folic acid and pyridoxine supplementation on characteristics of migraine attacks in migraine patients with aura: A double-blind, randomized placebo-controlled, clinical trial

Nutrition ◽  
2017 ◽  
Vol 38 ◽  
pp. 74-79 ◽  
Author(s):  
Gholamreza Askari ◽  
Morteza Nasiri ◽  
Hassan Mozaffari-Khosravi ◽  
Masod Rezaie ◽  
Mahdieh Bagheri-Bidakhavidi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Folic Acid ◽  
Controlled Clinical Trial ◽  
Double Blind

scholarly journals Does High-Dose Metformin Cause Lactic Acidosis in Type 2 Diabetic Patients after CABG Surgery? A Double Blind Randomized Clinical Trial

2011 ◽  
Vol 6 (1) ◽  
pp. hi.2011.e8 ◽  
Author(s):  
Afshin Gholipour Baradari ◽  
Mohammad Reza Habibi ◽  
Hadi Darvishi Khezri ◽  
Mohsen Aarabi ◽  
Mohammad Khademloo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lactic Acidosis ◽  
Randomized Clinical Trial ◽  
Diabetic Patients ◽  
High Dose ◽  
Type 2 Diabetic Patients ◽  
Double Blind ◽  
Cabg Surgery ◽  
Type 2 Diabetic

Prevention of Incipient Diabetic Nephropathy by High-Dose Thiamine and Benfotiamine

Diabetes ◽  
2003 ◽  
Vol 52 (8) ◽  
pp. 2110-2120 ◽  
Author(s):  
R. Babaei-Jadidi ◽  
N. Karachalias ◽  
N. Ahmed ◽  
S. Battah ◽  
P. J. Thornalley
Keyword(s):  
Diabetic Nephropathy ◽  
High Dose ◽  
Incipient Diabetic Nephropathy

scholarly journals The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-11
Author(s):  
Xuemei Liu ◽  
Juanjuan Fu ◽  
Tao Fan ◽  
Wei Liu ◽  
Hongli Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Study Protocol ◽  
Common Cold ◽  
Dose Group ◽  
Deficiency Syndrome ◽  
Phase Ii Clinical Trial ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

Background. Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. Methods/Design. This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson’s scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson’s scale and TCM symptom scale. Ethics and Trial Registration. This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).

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