Flaxseed and Cardiovascular Risk Factors: Results from a Double Blind, Randomized, Controlled Clinical Trial

Abstract Objectives Cardiovascular diseases have a multifaceted, it causes modern epidemic; Recognizing in the risk factor stage, is crucial, given the risk of progression to cardiovascular disease. Ibn Sīnā, described CVDs as a resultant of gradual derangement of Quwwat ghādhiya (Nutritive faculty); in which management with ghidhā’ (diet), tadābīr (regimens), dawā’ (drug) has been received. To evaluate the effect of Arjun Chāl (Terminalia arjuna) in CVD risk factors. And to evaluate the drug safety. Methods This is a randomized controlled clinical trial. Total 120 patients were screened at OPD of NIUM hospital, Bangalore during 2018–19, only 48 patients fulfilled the inclusion criteria and signed written informed consent and their detailed medical history was recorded. Arjun Chāl powder (5 gm BD) for eight weeks administered in test group (n=24), Amlodipine (5 mg) and Atorvastatin (10 mg) once a day for same duration administered in control group (n=24). Efficacy of the drug assessed by the Lipid profile, BP and BMI; lipid profile were performed at baseline and at 8 weeks, while BP and BMI performed at baseline, 15, 30, 45, and 60th day intervals. Study was completed by 40 patients. The results of both the therapies were then compared and statistically analyzed. Results Totally, both groups reduces assessment parameters i.e. statistically highly significant (p<0.001). Test group showed greater reduction in terms of all assessment parmeters. But, the difference between both the groups was statistically non-significant p>0.05. Conclusions Both test and control drugs were effective, but Arjun Chāl had a slight edge over amlodipne and atorvastatin, and was found to be safe and well tolerated. It has a cardio protective potential and hence effective to delay/prevent CVD in patient with cardiovascular risk factor.Keywords: Unani System of Medicine; T. arjuna; Arjun Chāl; Efficacy; Safety; Cardiovascular risk factor.

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Contributions of Vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial

10.21203/rs.2.383/v1 ◽

2019 ◽

Author(s):

Catarina Magalhaes Porto ◽

Tatiana de Paula Santana da Silva ◽

Everton Botelho Sougey

Keyword(s):

Risk Factors ◽

Clinical Trial ◽

Vitamin D ◽

Depressive Symptoms ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Vitamin D Supplementation ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo

Abstract Background Depression, the leading cause of chronic disability worldwide, comprises an important cardiovascular risk factor, increasing the relative risk of coronary artery disease and cardiovascular morbidity and mortality. Concomitant with the higher prevalence of depression, there is also a reduction in exposure to sunlight, with increased urbanization and industrialization and the use of sunscreens leading to a decrease in serum levels of 25-hydroxyvitamin D. In this sense, this essay intends to evaluate the action supplementation with vitamin D in the management of depressive symptoms and cardiovascular risk factors, increasing the limited evidence on the potential effects of supplementation in situations related to mood regulation. Methods This is a randomized, double-blind, placebo-controlled clinical trial, built in accordance with SPIRIT, involving 224 adults aged 18-59 years with depression on antidepressants, no history of vitamin D supplementation, psychiatric comorbidities, chronic kidney disease, hypercalcemia, and neoplasms, attended at the psychiatric outpatient clinics of two universities in northeastern Brazil. Consent and eligible participants will be randomly assigned to the intervention groups (n = 112) who will receive vitamin D supplementation, 50,000 IU weekly for six months, and control (n = 112) who will use weekly placebo for six months. Measurements for the monitoring of depressive symptoms, clinical trials, and laboratory tests to assess cardiovascular risk factors and serum vitamin D levels will be performed at the beginning, during and after the intervention period. Discussion This is the first trial to test the efficacy of vitamin D supplementation in reducing cardiovascular risk and as adjuvant to antidepressant therapy over a long period (six months). The obtained results will support the understanding of the therapeutic effects of vitamin D supplementation in the management of mood disorders, as well as corroborate in the direction of public policies aimed at vitamin supplementation to prevent cardiovascular risk.

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