Protective Effect of Zingiber Officinale L. Extract in Hypertensive Patients

NCT05682911 | Completed Early Phase 1 DMC

• 1 other identifier: 026-HV/HP-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperlipidemia is a well-known risk factor for cardiovascular diseases (CVDs). Coronary heart disease, stroke, and atherosclerosis are among the primary cause of death. Various medicines are available for the treatment of hyperlipidemia however, they are linked with serious unwanted effects. Zingiber officinale L. extract (Ginger) was used in folklore medicine as a hypolipidemic agent, Although, its clinical trial studies were not been investigated in the Pakistani population yet. Our clinical study is the first to assess the hypolipidemic, antioxidant, and cardioprotective effect of ginger tablets on dyslipidemic patients regarded as important risk factors for cardiovascular morbidity. A total of 40 dyslipidemic patients of age (18-65 years) of either sex were recruited in Al-Khidmat Hospital Karachi and allocated into two groups; the Simvastatin group (20 mg OD) and the Ginger treated group (500mg Ginger tablets BD) for 2 months. At baseline, their Blood pressure (BP), heart rate (HR), Insomnia severity index (ISI), Minimental state examination (MMSE), Lipid profile, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), creatine kinase (CK-MB), C-reactive protein, Superoxide Dismutase (SOD) \& Glutathione Peroxidase (GPx) were recorded and repeated after 2 months of follow-up.

Conditions

The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive Patients

Keywords

Zingiber officinale L., Hyperlipidemia, Clinical study,Cardioprotective, Antioxidant

Outcome Measures

Primary Outcomes (2)

• Assessment of total lipid profile

  Change in total cholesterol, triglycerides, High Density Lipoprotein (HDL)Low Density Lipoprotein-cholesterol (LDL) at baseline Change from baseline in total cholesterol, triglycerides, High Density Lipoprotein (HDL)Low Density Lipoprotein-cholesterol (LDL) after 2 months

  baseline to 2 month

• Assessment of cardio protective profile

  Change from baseline in serum glutamic-oxaloacetic transaminase (SGOT), glutamic-pyruvic transaminase (SGPT).

  baseline to 2 month

Secondary Outcomes (4)

• Evaluation of the antioxidant effect

  baseline to 2 months

• Effect on sleep cycle

  baseline to 2 months

• Effect on C-reactive protein (CRP)

  baseline to 2 months

• Effect on memory

  baseline to 2 months

Study Arms (2)

Zingiber Officinale L (Ginger) treated group n=20

EXPERIMENTAL

Ginger tablets 500mg twice a day (BD) for two month

Drug: Zingiber officinale L. tablets

Simvastatin treated group n=20

ACTIVE COMPARATOR

Simvastatin 20 mg tablet once a day (OD) for two month

Drug: Simvastatin 20mg

Interventions

Zingiber officinale L. tablets DRUG

Zingiber officinale L. tablets 500mg twice daily

Also known as: Ginger tablets

Zingiber Officinale L (Ginger) treated group n=20

Simvastatin 20mg DRUG

Simvastatin 20mg once a day for 2 months

Also known as: Limitrol 20mg

Simvastatin treated group n=20

Eligibility Criteria

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

You may qualify if:

• Males and females (18-65)
• Diagnosis of primary hypercholesterolemia
• With total cholesterol 200-239mg/dl and LDL 100-159mg/dl.

You may not qualify if:

• Familial hypoalphalipoproteinemia
• Patients receiving antihyperlipidemic agents (Statins, Niacin, Fibrates and Bile Sequestrants) were excluded in recent past.
• Pregnant, breast feeding and women likely to become pregnant
• Subjects excluded who suffered from allergy or hypersensitivity from Ginger or its tablet excipients.
• All those subjects excluded with severe or unstable medical conditions like renal failure, Seizures, previous liver surgery, poor controlled diabetes, and drug/alcohol dependence.

Sponsors & Collaborators

• Jinnah Sindh Medical University: lead
• Al Khidmat Hospital Nazimabad Karachi: collaborator
• Medics Laboratories (Pvt.) Ltd.: collaborator

Study Sites (1)

Alkhidmat Hospital

Karachi, Sindh, 75850, Pakistan

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

ginger extract; Simvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Blinding was maintained by keeping identical packaging of the ginger and simvastatin drugs with different codes, and no aroma was detected from either; the participants and their care giver were blinded to the treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A two-arm parallel assignment involves two groups of participants. One group receives simvastatin 20mg OD, and the other group receives 500mg Ginger extract tablet BD.

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2018
• Primary Completion: June 2, 2018
• Study Completion: June 30, 2018
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)