Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05682911
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2022-11-26
Brief Title:
Protective Effect of Zingiber Officinale L Extract in Hypertensive Patients
Sponsor:
Jinnah Sindh Medical University
Organization:
Jinnah Sindh Medical University
Study Overview
Official Title:
Hypolipidemic Cardioprotective and Antioxidant Effect of Zingiber Officinale L Extract in Hypertensive Patients A Clinical Approach
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 No2 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-HVHP-2017 Protocol Number ICCBSIEC-026-HVHP-2017Protocol20 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 11 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 200-239mgdl and LDL 100-159mgdl 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 drugalcohol 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 andor vomiting abdominal pain metallic taste symptoms related to an allergic reaction headache dizziness or any other undesirable effect
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 11 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 200-239mgdl and LDL 100-159mgdl 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 drugalcohol 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 andor vomiting abdominal pain metallic taste symptoms related to an allergic reaction headache dizziness or any other undesirable effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None