To Compare the Effects of Herbal Medicines With Traditional Allopathic Medicines in Cases of Patients With Metabolic Syndrome
NCT Number: NCT06515652
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome
Interventions: DRUG: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun
Sponsor: Hamdard University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-08-30
Locations: Prof. Dr. M. Sajid Abbas Jaffri, Karachi, Sindh, 75600, Pakistan

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 22.5 million people, compared with 17.5 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 and/or accessibility.

Herbal drugs are being used worldwide in the management of metabolic syndrome now a days. Some of the herbs e.g. 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, S.creatinine, 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.

Primary Outcome Measures: Glycosylated hemoglobin, at day 0 and day 90, 3 months|Systolic blood pressure, diastolic blood pressure, at day 0, day 30, day 60 and day 90, 3 months|triglyceride level, at day 0, day 30, day 60 and day 90, 3 months|high density lipoprotein level, at day 0, day 30, day 60 and day 90, 3 months|waist hip ratio, at day 0 and day 90, 3 months
Secondary Outcome Measures: Fasting blood sugar, random blood sugar, at day 0, day 30, day 60 and day 90, 3 months|serum cholesterol level, at day 0, day 30, day 60 and day 90, 3 months|serum creatinine level, at day 0, day 30, day 60 and day 90, 3 months