Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515652
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
To Compare the Effects of Herbal Medicines With Traditional Allopathic Medicines in Cases of Patients With Metabolic Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
To Compre the Efficacy and Safety of Herbal Medicine With Allopathic Therapy for Metabolic Syndrome A Randomized Multi-center Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Metabolic syndrome is an important global public health problem and comprises a group of complex risk factors including obesity dyslipidemia hyperglycemia and hypertension One of the main diagnostic components of metabolic syndrome is obesity which is usually measured by the waist circumference and the intra-abdominal visceral fat in addition to dyslipidemia the condition of raised triglycerides and reduced high density lipoprotein HDL-cholesterol in blood other components are raised blood pressure and fasting plasma glucose all of which are related to weight gain
Metabolic syndrome is related to cardio metabolic risk factors and lipid disorders Worldwide cardiovascular diseases CVD are the leading cause of mortality and morbidity It is expected that by 2030 mortality from CVD will reach 225 million people compared with 175 million deaths in 2012
Major pharmacological interventions include management of dyslipidemia with statins decreasing prothrombotic risk with antiplatelet drugs and the use of insulin sensitizers to decrease the risk of diabetes In addition to non-pharmacologic interventions that improve BP pharmacological agents provide the primary basis for hypertension management in the majority of patients Among major antihypertensive agents angiotensin-converting enzyme ACE inhibitors angiotensin receptor blockers ARBs calcium channel blockers CCBs and thiazide or thiazide-like diuretics are preferentially recommended in the general condition because of their additional cardiovascular protection effects andor accessibility
Herbal drugs are being used worldwide in the management of metabolic syndrome now a days Some of the herbs eg Terminalia arjuna Trigonella Foenum-graecum Allium Sativum Cinnamon verum and Zingiber Officinale are being used very effectively in managing metabolic syndrome
METHODOLOGY
The basic purpose of this study will be to explore a poly herbal combination for effective and safe management of metabolic syndrome This is a multicenter prospective study will be conducted in the department of Pharmacology HCMD in collaboration with Hamdard University Hospital National Medical Center and Amna Unani Hospital
After fulfilling the inclusion and exclusion criteria a total of 200 patients will be enrolled and divided in 2 groups One group will be given allopathic combination while the other group will be given a poly herbal formulation Important parameters include BMI Systolic and Diastolic blood pressure lipid profile HbA1c Screatinine Urinary Albumin Urinary Creatinine ALT AST Follow up will be done at day 0 30 60 90th of treatment The data will be recorded in a tabulated form and statistical analysis will be done at the end of the study to see the significance of the two studies
Metabolic syndrome is related to cardio metabolic risk factors and lipid disorders Worldwide cardiovascular diseases CVD are the leading cause of mortality and morbidity It is expected that by 2030 mortality from CVD will reach 225 million people compared with 175 million deaths in 2012
Major pharmacological interventions include management of dyslipidemia with statins decreasing prothrombotic risk with antiplatelet drugs and the use of insulin sensitizers to decrease the risk of diabetes In addition to non-pharmacologic interventions that improve BP pharmacological agents provide the primary basis for hypertension management in the majority of patients Among major antihypertensive agents angiotensin-converting enzyme ACE inhibitors angiotensin receptor blockers ARBs calcium channel blockers CCBs and thiazide or thiazide-like diuretics are preferentially recommended in the general condition because of their additional cardiovascular protection effects andor accessibility
Herbal drugs are being used worldwide in the management of metabolic syndrome now a days Some of the herbs eg Terminalia arjuna Trigonella Foenum-graecum Allium Sativum Cinnamon verum and Zingiber Officinale are being used very effectively in managing metabolic syndrome
METHODOLOGY
The basic purpose of this study will be to explore a poly herbal combination for effective and safe management of metabolic syndrome This is a multicenter prospective study will be conducted in the department of Pharmacology HCMD in collaboration with Hamdard University Hospital National Medical Center and Amna Unani Hospital
After fulfilling the inclusion and exclusion criteria a total of 200 patients will be enrolled and divided in 2 groups One group will be given allopathic combination while the other group will be given a poly herbal formulation Important parameters include BMI Systolic and Diastolic blood pressure lipid profile HbA1c Screatinine Urinary Albumin Urinary Creatinine ALT AST Follow up will be done at day 0 30 60 90th of treatment The data will be recorded in a tabulated form and statistical analysis will be done at the end of the study to see the significance of the two studies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None