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

To Compre the Efficacy and Safety of Herbal Medicine With Allopathic Therapy for Metabolic Syndrome: A Randomized , Multi-center, Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syeda Amber Zaidi, MBBS MPhil; Phone Number: 03323188867; Email: amberzaidi36@gmail.com
• Study Contact Backup: Name: Syed Mohsin Turab, MBBS MPhil PhD; Phone Number: 03332115515; Email: mohsin.turab@hamdard.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75600
      • Recruiting
      • Prof. Dr. M. Sajid Abbas Jaffri
      • Contact: Shiraz M Siddiqui, PhD
      • Principal Investigator: Syeda A Zaidi, MBBS MPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ageing between 35-65 years;
• Patients with a diagnosis of metabolic syndrome according to the criteria of IDF 2005

Exclusion Criteria:

• Pregnant & lactating female
• Use of insulin or sulfonamide derivative oral antidiabetic drugs
• Doing heavy physical activity or working in a physically demanding job
• Presence of liver or kidney disease, or immune deficiency
• Patients with history of myocardial infarction, coronary artery bypass surgery, unstable angina & cardiac failure.
• Conditions that will seriously affect weight management such as having had bariatric surgery
• Determined to have had an unintentional sudden weight loss of more than 5% in the last three months
• Intellectual disability or significant medical or psychiatric illness as documented by the referring doctor.
• Any contraindication to the use of drugs involved in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Allopathic; Tablet.Rosuvastatin 10mg once daily for 3 months; Tablet. Telmisartan 40mg once daily for 3 months; Tablet. Sitagliptin / Metformin 50/500mg once daily for 3 months	Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun; Comparing allopathic and herbal group of drugs for metabolic syndrome
Active Comparator: Herbal; Cinammon powder 2 gm once daily for 3 months; Garlic powder 1 gm once daily for 3 months; Ginger powder 4 gm once daily for 3 months; Fenugreek powder 10 gm once daily for 3 months; Arjuna 2 gm once daily for 3 months	Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun; Comparing allopathic and herbal group of drugs for metabolic syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hamdard University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Hypertension; Type 2 Diabetes; Hyperlipidemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Incretins; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Rosuvastatin Calcium; Metformin; Sitagliptin Phosphate; Telmisartan
• Other Study ID Numbers: FHMS HamdardUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No