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

NCT06515652 | Recruiting

• 1 other identifier: FHMS HamdardUniversity
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Keywords

Hyperlipidemia; Type 2 Diabetes; Hypertension; Obesity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Fasting blood sugar, random blood sugar

  3 months

• serum cholesterol level

  3 months

• serum creatinine level

  3 months

Study Arms (2)

Allopathic

ACTIVE COMPARATOR

1. Tablet.Rosuvastatin 10mg once daily for 3 months 2. Tablet. Telmisartan 40mg once daily for 3 months 3. Tablet. Sitagliptin / Metformin 50/500mg once daily for 3 months

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

Herbal

ACTIVE COMPARATOR

1. Cinammon powder 2 gm once daily for 3 months 2. Garlic powder 1 gm once daily for 3 months 3. Ginger powder 4 gm once daily for 3 months 4. Fenugreek powder 10 gm once daily for 3 months 5. Arjuna 2 gm once daily for 3 months

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

Interventions

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

Comparing allopathic and herbal group of drugs for metabolic syndrome

Allopathic; Herbal

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Prof. Dr. M. Sajid Abbas Jaffri

Karachi, Sindh, 75600, Pakistan

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Hyperlipidemias; Diabetes Mellitus, Type 2; Hypertension; Obesity

Interventions

Rosuvastatin Calcium; Metformin; Sitagliptin Phosphate; Telmisartan; ginger extract

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Triazoles; Azoles; Pyrazines; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Syeda Amber Zaidi, MBBS MPhil

CONTACT

03323188867; amberzaidi36@gmail.com

Syed Mohsin Turab, MBBS MPhil PhD

CONTACT

03332115515; mohsin.turab@hamdard.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitstant Professor

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 23, 2024
• Study Start: September 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)