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| Name | Class |
|---|---|
| Jinnah Postgraduate Medical Centre | OTHER_GOV |
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The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. The main question that aims to search is
Does the herbal combination formula effective to lower the high blood glucose levels in Type2 diabetics
Is the herbal combination therapy is safe for human use
Does this treatment plan reduces the blood sugar level comparative to Metformin 500 mg TID The trial is also comparing its efficacy in comparison to a standard anti diabetic drug Metformin In the study wing, the volunteer diabetic patients will take the herbal capsule 500mg TID and in the control group the volunteer patients will take Metformin 500 mg TID.
Preclinical evaluation studies including stability, dissolution and anti-microbial testing were performed. The formulation was also subjected to gas chromatography-mass spectrometry (GCMS). The powdered formulation was analyzed for LD-50 followed by two-center, unblinded, non-randomized controlled clinical trial with convenient sampling was conducted over 24 weeks in 500 adults with T2DM (HbA1c 7.5-10%). Participants were assigned to receive either polyherbal capsules (~500 mg three times daily, n = 250) or metformin (500 mg three times daily, n = 250). Primary outcome was HbA1c reduction; secondary outcomes included fasting/postprandial glucose, urinary protein, urinary glucose, lipid profile, body weight, and safety. Statistical analyses were performed using two-way ANOVA and unpaired t-tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin - control are of the study | Active Comparator | Metformin is standardized hypoglycemic agent with global accepted efficacy & safety |
|
| DIAB-PHC1 - Treatment arm of the study | Experimental | The investigational formulation consisted of Syzygium cumini, Momordica charantia, Wrightia tinctoria and Gymnema sylvestre. Raw plant materials were procured from local herbal markets and authenticated shade dried and powdered. The powder was capsulated with avverage weight of 500 mg /capsule. Capsules were given TID with meals to the patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIAB-PHC1 | Drug | a novel poly-herbal hard gelatin capsule formulation comprising Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in a scientifically optimized ratio. Although each of these herbs is traditionally recognized for its individual anti-diabetic activity, their combination in a standardized dosage form has not previously been reported. The study further strengthens its novelty by conducting comprehensive pre-clinical safety evaluations, confirming the absence of toxicity before proceeding to controlled clinical investigations. |
| Measure | Description | Time Frame |
|---|---|---|
| glycated hemoglobin (HbA1c) | The primary objective is to assess improvements in glycated hemoglobin (HbA1c) and fasting/ post-prandial plasma glucose. | From two weeks to six months time period |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Proteins | The secondary objectives are to evaluate reduction in the amount of proteins in urine | At least Six months |
| Urinary Glucose | regular check for the urinary glucose levels as a parameter for improved glycemic control |
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Inclusion Criteria:
Exclusion Criteria:
Patients who do not agree willingly to participate in research.
this is not a very much common situation in Pakistan
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| Name | Affiliation | Role |
|---|---|---|
| Mehboob Alam, PhD | Department of Pharmacology, Institute of Basic Medical Sciences, JPMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mehboob Faryal Diagnostic Center | Karachi | Sindh | 74700 | Pakistan |
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| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Main reference | View IPD |
to keep the privacy & anonymity of the individual participant of the study, as committed at the time of induction
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003921 | Diabetes Mellitus, Experimental |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Non-randomized control trial. Two study arms. Test drug (polyherbal drug) and control group.
Treatment in the both arms for 6 months at-least. Follow-up every 15 days. Revise clinical investigations of HbA1c, Urinary proteins and glucose
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| Metformin | Drug | Standard oral hypoglycemic comparator |
|
|
| 6 months |
it is the main reference used to identify definitions of the Diabetes & its complications |
| D004700 | Endocrine System Diseases |