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NCT Number: NCT06515652

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

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. M. Sajid Abbas Jaffri

Karachi, Sindh, 75600, Pakistan

Location status: Recruiting

Location contact

Shiraz M Siddiqui, PhD

CONTACT

Syeda A Zaidi, MBBS MPhil

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Comparing allopathic and herbal group of drugs for metabolic syndrome

Primary outcomes

  1. Glycosylated hemoglobin

    Time frame: 3 months

    at day 0 and day 90

  2. Systolic blood pressure, diastolic blood pressure

    Time frame: 3 months

    at day 0, day 30, day 60 and day 90

  3. triglyceride level

    Time frame: 3 months

    at day 0, day 30, day 60 and day 90

  4. high density lipoprotein level

    Time frame: 3 months

    at day 0, day 30, day 60 and day 90

  5. waist hip ratio

    Time frame: 3 months

    at day 0 and day 90

Secondary outcomes

  1. Fasting blood sugar, random blood sugar

    Time frame: 3 months

    at day 0, day 30, day 60 and day 90

  2. serum cholesterol level

    Time frame: 3 months

    at day 0, day 30, day 60 and day 90

  3. serum creatinine level

    Time frame: 3 months

    at day 0, day 30, day 60 and day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Syed Mohsin Turab, MBBS MPhil PhD

CONTACT

[email protected]

03332115515

Syeda Amber Zaidi, MBBS MPhil

CONTACT

[email protected]

03323188867

Sponsors and collaborators

Lead sponsor

Hamdard University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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