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To Compare the Effects of Herbal Medicines With Traditional Allopathic Medicines in Cases of Patients With Metabolic Syndrome

NCT06515652 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun

Comparing allopathic and herbal group of drugs for metabolic syndrome

Sponsors & Collaborators

  • Hamdard University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-07-30
Completion
2024-08-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515652 on ClinicalTrials.gov