Protective Effect of Zingiber Officinale L. Extract in Hypertensive Patients
Condition: The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive Patients
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      1. Study area and setting The study covered the period of January, 2018 to June, 2018 in
           the Al-Khidmat Medical and Diagnostic Center Nazimabad No.2, Karachi. This was carried
           out with the cooperation of Cardiac OPD and Laboratory Department of Al-Khidmat Medical
           and Diagnostic Center. All procedures were approved by the Independent Ethics Committee
           (IEC) of International Center for Chemical and Biological Sciences (ICCBS), University
           of Karachi (Study Number. 026-HV/HP-2017, Protocol Number.
           ICCBS/IEC-026-HV/HP-2017/Protocol/2.0) dated December 08, 2017.

        2. Study design This was single blind randomized clinical Study of 40 hyperlipidemic
           patients. The determination of sample size was done on basis of data from past studies
           and calculated from formula on SPSS. All the newly diagnosed hyperlipidemic patients
           were recruited according to the inclusion and exclusion criteria. the written informed
           consent in local language was being taken to all before the study. The questionnaires
           used to record information related to the demographic profile, age, gender, family
           history, past medical history, past laboratory findings, diagnosis and current
           treatment. All pateints were examined with blood pressure, pulse rate, total lipid
           profile and cardio-vascular biomarker.

        3. Selection of participants A total 40 newly diagnosed hyperlipidemic patients visiting
           Cardiac OPD at Al-Khidmat Medical and Diagnostic Center, Nazimabad No. 2 Karachi were
           selected for this study on basis of inclusion and exclusion criteria. Patients were
           randomized (1:1) using a computer-generated table into two groups: the control group
           received simvastatin and treated group powder tablets twice a day. Ginger treated group
           was treated with ginger powder tablets 500mg twice a day (BD) for two month while
           Simvastatin treated group was maintained on simvastatin 20 mg tablet once a day (OD) for
           two month. All the patients were over eighteen years of age, conversant in Urdu,
           consented to be available for participation in eight week study (Two months). The
           duration of treatment was decided on basis of previous studies carried.

           The inclusion criteria included patients were above 18 years age, either male or female
           with the diagnosis of hyperlipidemia, total cholesterol up to 200-239mg/dl and LDL
           100-159mg/dl. They must not receive lipid-lowering drugs for at least 3 months prior to
           the recruitment and clinical laboratory tests (CBC, Blood Chemistry, and Urinalysis)
           were within normal ranges. Exclusions criteria were any cardiovascular diseases,
           seizures, previous liver surgery, poor controlled diabetes, and drug/alcohol dependence,
           pregnancy and GI ulcer. Subjects receiving antihyperlipidemic agents (Statins, Niacin,
           Fibrates and Bile Sequestrants) were excluded in recent past. 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 were blinded to the treatment
           allocation.

        4. Study protocol Patients that met the above criteria and gave written consent were
           randomized to the Treatment group (ginger tablet) and the Control group (Simvastatin)
           for 8 weeks. During the initial evaluations, all patients interviewed by taking patients
           previous history included the questions about medical illness, medications, allergies
           and family history of illness and disease status, blood pressure and pulse rate on every
           visit. Blood sample (5 ml) was taken before and after treatment for total Lipid Profile,
           SGPT, SGOT, CK-MB and C-RP. Erythrocyte antioxidant enzymes activity of superoxide
           dismutase (SOD) and glutathione peroxidase (GPX) were determined by spectrometric method
           using Ransod and Ransel kit, respectively. Upon every visit all patients were also
           screened with their blood pressures, heart rate, sleep pattern by insomnia severity
           indexed (26) and memory by MMSE (27). Analysis was blinded and was performed at the same
           laboratory for all patients. All Adverse effects reported during the study period were
           monitored using a structured questionnaire. The questionnaire consisted of questions
           about the occurrence of ADR such as diarrhea, nausea and/or vomiting, abdominal pain,
           metallic taste, symptoms related to an allergic reaction, headache, dizziness or any
           other undesirable effect.
    

Intervention name(s): Zingiber officinale L. tablets; Simvastatin 20mg
Intervention type(s): Drug; Drug
Intervention description(s): Zingiber officinale L. tablets 500mg twice daily; Simvastatin 20mg once a day for 2 months
Other intervention name(s): Ginger tablets; Limitrol 20mg
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Zingiber officinale L., Hyperlipidemia, Clinical study,Cardioprotective, Antioxidant