The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive PatientsEarly Phase 1NCT05682911
Protective Effect of Zingiber Officinale L. Extract in Hypertensive Patients
A Early Phase 1 study testing Zingiber officinale L. tablets and Simvastatin 20mg in people with The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive Patients, run by Jinnah Sindh Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive Patients
- What is being tested?
- Zingiber officinale L. tablets and Simvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 30 Jun 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females (18-65)
- Diagnosis of primary hypercholesterolemia
- With total cholesterol 200-239mg/dl and LDL 100-159mg/dl.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypolipidemic, Cardioprotective and Antioxidant Effect of Zingiber Officinale L. Extract in Hypertensive Patients: A Clinical Approach
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- Being tested
- Zingiber officinale L. tablets, Simvastatin 20mg
- Keywords
- Zingiber officinale L., Hyperlipidemia, Clinical study,Cardioprotective, Antioxidant
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zingiber officinale L. tabletsDrug
Also called Ginger tablets
Zingiber officinale L. tablets 500mg twice daily
Simvastatin 20mgDrug
Also called Limitrol 20mg
Simvastatin 20mg once a day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Zingiber Officinale L (Ginger) treated group n=20 | Experimental | Ginger tablets 500mg twice a day (BD) for two month Receives: Drug: Zingiber officinale L. tablets |
| Simvastatin treated group n=20 | Active comparator | Simvastatin 20 mg tablet once a day (OD) for two month Receives: Drug: Simvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 2 month
Assessment of cardio protective profile
Change from baseline in serum glutamic-oxaloacetic transaminase (SGOT), glutamic-pyruvic transaminase (SGPT).
Measured: baseline to 2 month
Secondary outcomes (4)
Evaluation of the antioxidant effect
Change From Baseline in antioxidant markers Superoxide dismutase (SOD), Glutathione peroxidase
Measured: baseline to 2 months
Effect on sleep cycle
To evaluate the sleep patterns by using Insomnia Severity Index (ISI) scale after 2 month
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: baseline to 2 months
Effect on C-reactive protein (CRP)
Change From Baseline in antioxidant marker C-reactive protein (CRP)
Measured: baseline to 2 months
Effect on memory
Change in memory enhancement effect through mini mental state examination (MMSE) scale at baseline and after 2 months
The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be memory impairment.
Measured: baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Jan 2018
- Primary completion2 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Sindh Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Al Khidmat Hospital Nazimabad Karachi, Medics Laboratories (Pvt.) Ltd.
- Responsible party
- Principal investigator, sadaf naeem, Jinnah Sindh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682911
- Sponsor's protocol ID
- 026-HV/HP-2017
- Status last verified
- Jan 2023
- First submitted
- 26 Nov 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypolipidemic, Cardioprotective and Antioxidant Effect of Zingiber Officinale L. Extract in Hypertensive Patients: A Clinical Approach
- ClinicalTrials.gov ID
- NCT05682911
- Acronym / sponsor ID
- 026-HV/HP-2017
- Keywords
- Zingiber officinale L., Hyperlipidemia, Clinical study,Cardioprotective, Antioxidant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jinnah Sindh Medical UniversityUniversity, hospital or other
- Collaborators
- Al Khidmat Hospital Nazimabad Karachi, Medics Laboratories (Pvt.) Ltd.
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zingiber Officinale L (Ginger) treated group n=20 | Experimental | Drug: Zingiber officinale L. tabletsGinger tablets 500mg twice a day (BD) for two month |
| Simvastatin treated group n=20 | Active comparator | Drug: Simvastatin 20mgSimvastatin 20 mg tablet once a day (OD) for two month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females (18-65)
- Diagnosis of primary hypercholesterolemia
- With total cholesterol 200-239mg/dl and LDL 100-159mg/dl.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zingiber officinale L. tabletsAlso: Ginger tabletsZingiber officinale L. tablets 500mg twice daily | Drug | Zingiber Officinale L (Ginger) treated group n=20 |
| Simvastatin 20mgAlso: Limitrol 20mgSimvastatin 20mg once a day for 2 months | Drug | Simvastatin treated group n=20 |
Primary outcome
Assessment of total lipid profile
Time frame: baseline to 2 month
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
Assessment of cardio protective profile
Time frame: baseline to 2 month
Change from baseline in serum glutamic-oxaloacetic transaminase (SGOT), glutamic-pyruvic transaminase (SGPT).
4 secondary outcomes
Evaluation of the antioxidant effect
Time frame: baseline to 2 months
Effect on sleep cycle
Time frame: baseline to 2 months
Effect on C-reactive protein (CRP)
Time frame: baseline to 2 months
Effect on memory
Time frame: baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Zingiber officinale L. tablets and Simvastatin 20mg in people with The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive Patients, run by Jinnah Sindh Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of total lipid profile (time frame: baseline to 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.