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| Name | Class |
|---|---|
| Hashmi Herbal Pharma (HHP) Registered Bahawalpur | UNKNOWN |
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Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.
This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.
volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.
On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.
Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.
Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Pre-diabetic placebo | Group of pre-diabetics receiving placebo BD for six weeks | ||
| Group B Pre-diabetic test | Group of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks |
| |
| Group C Diabetic test | Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal formulation | Dietary Supplement | Test candidate will be administered per oral before / with meal in two divided doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose Tolerance (FGT) | enhancement of fasting glucose tolerance (<100mg/dl) | six weeks |
| Glucose Tolerance (GT) | enhancement of oral glucose tolerance (<140mg/dl) | six weeks |
| HB-A1c | improvement in glycated hemoglobin (HB-A1c) percentage <6%, | six week |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile | serum Cholesterol level (mg/dl) | six weeks |
| Lipid Profile | Serum Triglycerides (mg/dl) | Six Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Functions | Serum Glutamate pyruvate transaminase (SGPT) (mg/dl) | six week |
| Liver Function | serum glutamate oxaloacetate transaminase (SGOT)(mg/dl) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H A Sattar Hashmi, M.Phil | scholar | Principal Investigator |
| Dr K A.Ansari, Ph.D | AP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hashmi Dawakhana | Khairpur Tamewali | Punjab Province | 63060 | Pakistan | ||
| University College of Conventional Medicine |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2019 | Mar 21, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Lipid Profile | Serum Low Density Lipids (LDL) (mg/dl) | Six week |
| Lipid Profile | Serum High Density Lipids (HDL) (mg/dl) | six week |
| six week |
| Liver Function | Alkaline phosphatase (ALP) | six week |
| Kidney Function | Serum creatinine (mg/dl) | six week |
| Kidney Function | Blood Urea Nitrogen (mg/dl) | six week |
| Bahawalpur |
| 63100 |
| Pakistan |
| D006943 | Hyperglycemia |