Anemia Clinical Trial
Official title:
Role of Ajwa Derived Polyphenols in Dyslipidaemias
World Health Organization report notifies of the escalating global burden of cardiovascular diseases (CVD), projecting that it will become the major worldwide cause of death and disability by 2020. The South Asian countries have the highest rates of CVD globally. It is widely acknowledged that South Asians have 40-60% higher risk of CVD linked to mortality, compared with other populations. Multiple human population studies have established the concentration of high density lipoprotein (HDL) cholesterol as an independent, inverse predictor of the risk of having a cardiovascular event. Furthermore, HDLs have several well-documented functions with the potential to protect against cardiovascular disease. This study trial is designed to find out the role of alternative medicine such as functional food to improve the dyslipidemia and particularly increase the levels of HDL in general population. We expect that the use of Ajwa dates will significantly enhance the level of HDL and reduce cardiovascular events in general population.
Overall lipid profile is important in cardiovascular diseases but particularly serum HDL
levels have long been recognized as an independent inverse prognostic marker of CVD, when the
Framigham study, in 1980s showed that HDL below 40-60mg/dl is of prognostic relevance. A rise
of 1mg/dl in HDL levels is considered to reduce coronary artery disease (CAD) risk to 2-3%.
Even patients with elevated total cholesterol (TC) and LDL, presenting a high HDL are seen to
be protected from atherosclerosis. Multiple human population studies have shown the
concentration of HDL cholesterol as an independent, inverse predictor of the risk of having a
cardiovascular event. Additionally, HDL has several well-documented functions with the
potential to protect against cardiovascular diseases. These include an ability to promote the
efflux of cholesterol from macrophages in the artery wall, inhibit the oxidative modification
of LDL, inhibit vascular inflammation, inhibit thrombosis, promote endothelial repair,
promote angiogenesis, anti-oxidant, enhance endothelial function, improve diabetic control,
and inhibit hematopoietic stem cell proliferation. HDL also exerts direct cardio protective
effect, which are mediated with its interactions with the myocardium.
Various studies have emphasised the high incidence of CVD within the South Asian countries.
The increased risk of cardiovascular events in South Asians at a younger age might be due to
unknown factors affecting plaque rupture, the interaction between prothrombotic factors and
atherosclerosis, or may be due to any undiscovered risk factors. Urbanisation and
westernisation is characterised by a distinct increase in the intake of energy dense foods, a
decrease in physical activity, and a heightened level of psychosocial stress, all of which
promote the development of hyperglycaemia, hypertension, and dyslipidaemia. Most common
dyslipidaemia in South Asians is low HDL-C and high triglycerides. High triglyceride and low
HDL-C levels are metabolically interlinked. This metabolic phenotype is also associated with
increased levels of small LDL particles despite relatively normal levels of LDL-C among South
Asians. This clinical syndrome is accompanied by insulin resistance, a condition frequently
referred to as atherogenic dyslipidemia, which is a common metabolic derangement among Asian.
South Asians not only have lower HDL levels but also have a higher concentration of small,
less-protective HDL particles. One proposed mechanism is presence of dysfunctional HDL
particles. Another potential explanation for the apparent blunted cardioprotection of HDL in
South Asians might be related to HDL particle size. Small particles might be less efficient
in reverse cholesterol transport. In general, HDL particle size tends to be lower in patients
with CHD and those with low HDL-C levels . Alarmingly, an estimated 60-80% of Pakistani
population has been reported to have low HDL. There are a number of non-pharmacological and
pharmacological recommendations for management of low HDL. Non-pharmacological (functional
food) strategies are reported to increase HDL levels around 10-15% and which include regular
exercise , body weight reduction in obese individuals , cessation of cigarette smoking in
smokers and dietary modifications like decrease intake of saturated trans-fatty acids with
increase intake of omega-3 polyunsaturated fatty acids . There are also a number of
pharmacological agents being considered as therapeutic options but the tolerability and
safety issues limit their use in addition to limited success in improving HDL. Therefore, the
focus of research now days had been toward the use of functional food which can play
significant role in cardiac protection. Ajwa dates have been recognized to contain the
nutritional and medicinal properties. These are a rich source of nutrition, containing
sugars, proteins, vitamins, high dietary fibres, minerals and fats, various phytochemicals
like sterols, polyphenols, flavonoids and glycosides. Ajwa fruit is gifted by nature and is
enriched with polyphenols and can act as a protective agent against many diseases. Various
studies have been conducted to investigate the presence of different polyphenols in Ajwa.
Different researchers have determined different phenolic components
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
Terminated |
NCT01535781 -
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
|
N/A | |
Completed |
NCT01432717 -
Study of ACE-536 in Healthy Postmenopausal Women
|
Phase 1 |