Metabolic SyndromeNCT06515652
To Compare the Effects of Herbal Medicines With Traditional Allopathic Medicines in Cases of Patients With Metabolic Syndrome
A study testing rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun in people with Metabolic Syndrome, run by Hamdard University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 30 Aug 2024
- Phase
- Interventional
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ageing between 35-65 years;
- Patients with a diagnosis of metabolic syndrome according to the criteria of IDF 2005
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Prof. Dr. M. Sajid Abbas Jaffri
Karachi, Sindh, 75600
Shiraz M Siddiqui, PhD
Syeda A Zaidi, MBBS MPhil
About this study
Official title: To Compre the Efficacy and Safety of Herbal Medicine With Allopathic Therapy for Metabolic Syndrome: A Randomized , Multi-center, Clinical Study
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.
Read more
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.
- Conditions
- Metabolic Syndrome
- Being tested
- rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun
- Keywords
- Hyperlipidemia, Type 2 Diabetes, Hypertension, Obesity
- Medical subject headings
- Metabolic Syndrome, Hyperlipidemias, Diabetes Mellitus, Type 2, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, ArjunDrug
Comparing allopathic and herbal group of drugs for metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| Allopathic | Active comparator | 1. Tablet.Rosuvastatin 10mg once daily for 3 months
2. Tablet. Telmisartan 40mg once daily for 3 months
3. Tablet. Sitagliptin / Metformin 50/500mg once daily for 3 months Receives: Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun |
| Herbal | Active comparator | 1. Cinammon powder 2 gm once daily for 3 months
2. Garlic powder 1 gm once daily for 3 months
3. Ginger powder 4 gm once daily for 3 months
4. Fenugreek powder 10 gm once daily for 3 months
5. Arjuna 2 gm once daily for 3 months Receives: Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin
at day 0 and day 90
Measured: 3 months
Systolic blood pressure, diastolic blood pressure
at day 0, day 30, day 60 and day 90
Measured: 3 months
triglyceride level
at day 0, day 30, day 60 and day 90
Measured: 3 months
high density lipoprotein level
at day 0, day 30, day 60 and day 90
Measured: 3 months
waist hip ratio
at day 0 and day 90
Measured: 3 months
Secondary outcomes (3)
Fasting blood sugar, random blood sugar
at day 0, day 30, day 60 and day 90
Measured: 3 months
serum cholesterol level
at day 0, day 30, day 60 and day 90
Measured: 3 months
serum creatinine level
at day 0, day 30, day 60 and day 90
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Sep 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SYEDA AMBER ZAIDI, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515652
- Sponsor's protocol ID
- FHMS HamdardUniversity
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compre the Efficacy and Safety of Herbal Medicine With Allopathic Therapy for Metabolic Syndrome: A Randomized , Multi-center, Clinical Study
- ClinicalTrials.gov ID
- NCT06515652
- Acronym / sponsor ID
- FHMS HamdardUniversity
- Conditions
- Metabolic Syndrome
- Keywords
- Hyperlipidemia, Type 2 Diabetes, Hypertension, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 23 Jul 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopathic | Active comparator | Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun1. Tablet.Rosuvastatin 10mg once daily for 3 months 2. Tablet. Telmisartan 40mg once daily for 3 months 3. Tablet. Sitagliptin / Metformin 50/500mg once daily for 3 months |
| Herbal | Active comparator | Drug: rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun1. Cinammon powder 2 gm once daily for 3 months 2. Garlic powder 1 gm once daily for 3 months 3. Ginger powder 4 gm once daily for 3 months 4. Fenugreek powder 10 gm once daily for 3 months 5. Arjuna 2 gm once daily for 3 months |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ageing between 35-65 years;
- Patients with a diagnosis of metabolic syndrome according to the criteria of IDF 2005
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, ArjunComparing allopathic and herbal group of drugs for metabolic syndrome | Drug | Allopathic, Herbal |
Primary outcome
Glycosylated hemoglobin
Time frame: 3 months
at day 0 and day 90
Systolic blood pressure, diastolic blood pressure
Time frame: 3 months
at day 0, day 30, day 60 and day 90
triglyceride level
Time frame: 3 months
at day 0, day 30, day 60 and day 90
high density lipoprotein level
Time frame: 3 months
at day 0, day 30, day 60 and day 90
waist hip ratio
Time frame: 3 months
at day 0 and day 90
3 secondary outcomes
Fasting blood sugar, random blood sugar
Time frame: 3 months
serum cholesterol level
Time frame: 3 months
serum creatinine level
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rosuvastatin, METFORMIN, Sitagliptin, Telmisartan, Cinnamon. garlic, Ginger, Methi dana, Arjun in people with Metabolic Syndrome, run by Hamdard 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syeda Amber Zaidi, MBBS MPhil (03323188867, amberzaidi36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (time frame: 3 months). The study lists 5 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 23 Jul 2024.