DESC:FIELD OF THE INVENTION
The present invention relates to composition comprising synergistic phytoconstituents blend in treatment in Diabetes mellitus. Further invention relates to process for preparation of composition comprising phytoconstituents without chemical excipients. Another invention relates to synergy blends of extract of Gymnema Sylvestre (Gudmar), Trigonella Foenum-Graecum (Methi), Cinnamomum verum (Cinnamon), Curcuma longa (Curcumin), Andrographis paniculata (Kalmegh), Salacia Oblonga (Saptarangi)
BACKGROUND OF THE INVENTION Diabetes is on the rise worldwide, and is a serious, lifelong disease that can lead to heart disease, stroke, and lasting nerve, eye and foot problems. People with diabetes have too much blood sugar because their body cannot move glucose into fat, liver, and muscle cells to be changed into and stored for energy. Prediabetes is another medical condition that occurs when you have abnormally higher levels of blood sugar, but not high enough for type 2 diabetes. Treatments like OHA, Insulin available but prevalence of diabetes increased day by day. Sometime OHA, Insulin can’t able to manage diabetes so additionally diet, supplements and other reversal things needful at present. In Botanical, Phytochemistry chemical-based preservative, excipients, additives and dosage modifying agent and hence it is not safe for prolong time. Here with this invention design with multiple synergy effect, statistical design to improve dosage evaluation parameters, Therapeutical efficacy, potency with no or minimal side effects. It is Excipientless aqueous transparent coated tablet
The US6042834A discloses an herbal composition for diabetes and a method of treatment for diabetes using the herbal composition.
Diabetes has been a known medical problem for some time. Treatment for diabetes typically requires the regular administration of insulin to the patient, either orally or by injection. Such a treatment of diabetes is a life-long course of treatment for the afflicted patient. For many patients, insulin injection is an unpleasant process. Also, the need for daily injections of insulin is hard on the patient's veins. Insulin treatment is costly and it is only a temporary reliever of diabetic symptoms. Continued treatment is necessary in order to control the disease. Therefore, there is a
need for a remedy and treatment for diabetes which is permanent, not temporary, and which is easily administered to or by the patient
OBJECTIVE OF INVENTION
The object of present invention relates to composition comprising synergistic phytoconstituents blend in treatment in Diabetes mellitus.
Further object of invention relates to process for preparation of composition comprising phytoconstituents without chemical excipients.
SUMMARY OF THE INVENTION
The present invention relates to composition comprising synergistic phytoconstituents blend in treatment in Diabetes mellitus.
Further invention relates to process for preparation of composition comprising phytoconstituents without chemical excipients.
Another invention relates to synergy blends of extract of Gymnema Sylvestre (Gudmar), Trigonella Foenum-Graecum (Methi), Cinnamomum verum (Cinnamon), Curcuma longa (Curcumin), Andrographis paniculata (Kalmegh), Salacia Oblonga (Saptarangi)
DETAILED DESCRIPTION OF THE INVENTION:
In Botanical, Phytochemistry generally 3 type of dosage form there i.e., Solid, Semisolid and liquid and generally it is made up with chemical-based preservative, excipients, additives and dosage modifying agent and hence it is not safe for prolong time. Here with this invention design with multiple synergy effect, statistical design to improve dosage evaluation parameters, Therapeutical efficacy, potency with no or minimal side effects. It is Excipientless aqueous transparent coated tablet developed by OEM technology.
• Taste evaluation is performed in different volunteers and invitro analysis found threshold bitterness concentration is 10 sec. confirmed taste masking.
• Micromeritics properties include Flow property, Density, Porosity, Carr’s Index improved in Synergy complex of Phytoconstituents as compare to pure raw form of Phytoconstituents. Raw form of Phytoconstituents contains poor characteristics like taste, odour, solubility, and stability, with synergistic blend technology, all problems overcome without excipients.
• Physical characterization by FTIR, DSC, XRPD and Malvern Particle size analyzer found that without interaction, key group remain same and improve compressibility for precious dose.
• As per the 3 months of ICH Stability outcome, there is no significant changes found in dosage release, Dissolution, Disintegration, Friability, Hardiness, Weight variation and appearance. This process not existing in any literature or in patent as per our literature survey.
• It will be good option as adjuvant therapy in diabetes as per Animal toxicity and Human clinical trial reports, results are attached in tables and figure. It is available in market since long with precious dosage and thousands of patients taken it and continue till date. As per clinical evidence, it shows reduces dosage of insulin with improvement in HBA1C, C-Peptide and average blood glucose. It reduces HBA1C score by 3.0 and 50% Reduction in Fasting and PPBS in 60 days as an adjuvant with glucose homeostasis. C-Peptide and Homa-B Score also improve in 60 days of human clinical trial. As per Chronic toxicity study and histopathology study, without any mortality, there is no abnormalities found in any organ and in hematological parameters. As per 90 Days of Histopathology study as per OECD, CPCSEA Guideline, it proven safe with mentioned dosage.
Phytochemicals play an important role in Diabetes management, but also some novel science Science behind Synergy Phytoconstituents are there for Blood glucose homeostasis. It includes synergy blends of extract of Gymnema Sylvestre (Gudmar), Trigonella Foenum-Graecum (Methi), Cinnamomum verum (Cinnamon), Curcuma longa (Curcumin), Andrographis paniculata (Kalmegh), Salacia Oblonga (Saptarangi). Following are detailed information of ingredients.
Gymnemic acid: Gymnemic acids are a class of chemical compounds isolated from the leaves of Gymnema sylvestre. They are anti-sweet compounds, or sweetness inhibitors, absorb re absorption of sugar in kidney and intestine. Insulin is the hormone produced by pancreatic ß-cells, with a central role in carbohydrate and fat metabolism. Eventually, it also stimulates insulin producing cell. Insulin is also a key target element of the autoimmune islet destruction leading to type 1
diabetes & it plays a triggering role, at least in rodent models, in diabetes pathogenesis. It is expressed not only by ß-cells but also in the thymus, where it plays a major role in central tolerance mechanisms. Finally, it plays an important role to regenerate ß-cells.
Cinnamon verum extract: Fatty liver and imbalance of liver function lead to increase blood sugar, hence as per our study it is proven compound in fatty liver recovery, & balance SGPT, SGOT by improve liver function. It Increased autophosphorlylation and decreased dephosphorylation of the insulin receptor is one mechanism that increases the insulin sensitivity. Cinnamon increases the amount of GLUT4 receptors as well as Insulin Receptor (IR) and Insulin Receptor substrates, thereby facilitating glucose entry into cells. The net result is a stimulation of Glycogen synthesis and inhibition of gluconeogenesis, improving glucose metabolism.
Trigonella extract: It promotes insulin secretion by closure of K+-ATP channels, membrane depolarization and stimulation of Ca2+ influx, an initial key step in insulin secretion. As with it also regulate LDL: HDL level by improving lipid metabolism. There are many links between cholesterol, HDL metabolism and the pathogenesis of Alzheimer’s Diabetes. The brain is the most cholesterol-rich organ in the human body and HDL is the only lipoprotein found in the CNS , where it is known to play a key role in synaptogenesis and in the maintenance of synapse plasticity of the hippocampus. The level of HDL in cerebrospinal fluid of Alzheimer’s patients is lower than that of the control subjects, suggesting that a low HDL in the cerebrospinal fluid may be a risk factor for Alzheimer’s Diabetes.
Curcumin complex: It has been documented that the oral consumption of curcumin in pre-diabetic and diabetic patients has a positive effect as an antidiabetic agent For diabetic symptoms it also give anti-inflammatory, antioxidant, antithrombotic, cardio and neuroprotective effects. As per our study, it has been proven that curcumin with high bioavailability is capable of increasing insulin sensitivity in liver, muscle and adipose tissue, increases glucose uptake in muscle and insulin secretion, which is reflected in the reduction of hyperglycemia, glycosylated hemoglobin, decrease of the homeostatic model assessment of insulin resistance (HOMA-IR) and decrease of serum lipids.
Kalmegh extract: In patients with diabetes Fatty liver and alcoholic liver cirrhosis, a kalmegh produced a significant reduction in fasting blood glucose and mean daily glucose levels from without hypoglycemia. Insulin requirement is also decreased by 20%, suggesting an alleviation of insulin resistance due to kalmegh through liver detoxification. Diabetic nephrotoxicity, S creatinine and other renal problem also recover remarkable within 6 months.
Salacia reticulata extract: It Significant help to decline in the levels of fasting blood glucose, HbA1c as well as HOMA-IR values and an increase in plasma insulin and hemoglobin levels.
Present invention relates to composition comprising synergistic phytoconstituents blend in treatment in Diabetes mellitus. Further invention relates to process for preparation of composition comprising phytoconstituents without chemical excipients. Another invention relates to synergy blends of extract of Gymnema Sylvestre (Gudmar), Trigonella Foenum-Graecum (Methi), Cinnamomum verum (Cinnamon), Curcuma longa (Curcumin), Andrographis paniculata (Kalmegh), Salacia Oblonga (Saptarangi)
In Phytochemistry science, to overcome limitation like taste masking and maltodextrin masking is key invention and its excipientless, chemical free, preservative free with OEM technology. Another major problem overcome excipientless (Without binder, Diluents, dosage modifying additives, Superdisintegrants) developed precious dosage i.e., aqueous transparent coated tablet with enhance solubility, dissolution, Stability, Potency & micromeritics properties. It is chemical free, less side effect, precious dosage, Convenient, inexpensive and key breakthrough is excipientless. it is breakthrough, because most of tablet dosage incorporate almost 50-90% of excipients or additives with preservative and its chemical form which has no role with disease cure, also harmful for long consumption. Our dosage design are excipientless and set as per pharmaceutical technology. It’s safe, precious with only active ingredients i.e., Synergy Phytoconstituents. Even as per clinical evidence by Human clinical trial it reduces HBA1C score by 3.0 and 50% Reduction in Fasting and PPBS in 60 days as an adjuvant with glucose homeostasis. Additionally, as per Chronic toxicity study and histopathology study, without any mortality, there is no abnormalities found in any organ and in hematological parameters.
Example
Example 1: Table No 1 details of composition in range
Synergistic phytoconstituents blend are formulated with different composition range for optimizing the one is as follow.
Optimization of tablet comprise synergy blend of Diabetes Mellitus
Sr. No.
Ingredients
F1
F2
F3
F4 F5
F6
F7
Mg
Mg
Mg
mg mg
mg
mg
1
Gymnema Sylvestre ext.
400
440
465
470 450
430
500
2
Trigonella Foenum-Graecum ext.
80
75
85
50 70
65
50
3
Cinnamomum verum ext.
70
55
45
70 60
50
40
4
Curcuma longa ext.
65
60
40
45 50
55
35
5
Salacia Oblonga ext.
30
20
25
20 30
40
20
6
Andrographis paniculata ext.
25
20
10
15 10
30
25
Total
670
670
670
670 670
670
670
Among all 7 formulation F5 is found to be optimize on the basis of statistical optimization of Dissolution, Solubility and micromeritics compatibility.
Dissolution Data with Other Products comparison showing Our Product is better. Blend targeted at gastric shows following dissolution data at pH 1.2 .
Table No 2: % Cumulative release of tablet in 0.1 N HCL
Several formulations of synergistic blend aiming GI track with pH 1.2 in HCL (0.1N) medium, dose dumping is notified within 30min by all formulation expect F5. Also, F5 is the only formulation showing near to 100% release within 45min of administration. Following that F5
Time (min)
F1
F2
F3
F4 F5
F6
F7
0
0
0
0
0 0
0
0
15
25.12
28.92
38.06
31.34 44.12
39.06
25.68
30
62.68
64.04
75.38
71.04 84.34
78.08
65.48
45
92.9
89.34
95.04
98.03 99.99
91.04
94.34
shows 99.99% release of drug enclosed by 45 minutes. According to above table for dissolution data 99.99% release is manifested by optimized F5.
Details of procedure for product preparation and range of excipients. Steps: -
1. Individual Phytoconstituents are cross check by suitable analytical technique (DSC, IR, UV).
2. Gymnema Sylvestre ext make a Knead with Distilled water and make a smooth semi solid like paste. Then required amount of Synergic blends are proceeded for mixing via solid dispersion method. Composition contain synergic blend of Trigonella Foenum-Graecum ext., Cinnamomum verum ext., Curcuma longa ext., Salacia Oblonga ext., Andrographis paniculata ext. are blend with wet granules of Gymnema Sylvestre ext and then mixed for 30-60min via Kneading method.
3. Then, proceed for pulverization at initially sieve number 22 and then 60.
4. Pulverized granules are subjected for drying at 45-600C for 45-90min using tray dryer.
5. Again pulverized by Sieve number 80 and Lastly, check flowability of synergic blend as per free flow compliance.
Table No 3: Granulation Process Parameter to produce synergic blend
Table No 4: Physical evaluation property of blend
Kneading time
Drying
Pulverize Through
(Min)
(40-50° C)
35-60 minutes
60-90 minutes
Sieve 80-100
Parameters
Modified tablet after granulation
Disintegration Time
200-240 sec
Dissolution Time
45min
Raw blend presenting poor characteristics for instance flow property ultimately affecting post formulation parameters namely disintegration time, dissolution time, friability and average weight resulting into poor bioavailability are significantly improved with limits ranging under IP after conducting granulation of raw synergic blend.
Details of the excipient are the role of it to make the product better.
As our formulation is excipient less, the phytoconstituents used in synergic blend itself replaces the role of excipients.
Table No 5 Excipient category and range.
As our formulation is excipientless, the phytoconstituents used in synergic blend itself replaces the role of excipients. Following are the role of individual phytoconstituents instead of excipients making product better.
Sr. No.
Ingredients
Concentration
mg
1
Gymnema Sylvestre ext.
450
2
Trigonella Foenum-Graecum ext.
70
3
Cinnamomum verum ext.
60
4
Curcuma longa ext.
50
5
Salacia Oblonga ext.
30
6
Andrographis paniculata ext.
10
Total
670
Stability study till 3 months.
Data of stability study carried out up to 3 months for ensuring safety, efficacy and quality of synergic blend are as follow.
Friability
0.8891
Average weight
670 ± 5
Table No 6 Stability Study of Optimized batch
After stability study conducted till 3 months with varying conditions concludes that no worthy is reported leading to decomposition or toxicity of synergic blend. Hence, it is compatible for oral administration.
Pre-Formulation Study.
Several parameters are examined to verify flow property of synergic blend are as follow.
Table No 7 Pre-Formulation Characteristics of Granules
Type I or Type II diabetes, once recognized as juvenile diabetes or insulin-dependent diabetes, is a chronic illness in which the pancreas produces slight or no insulin. Insulin is a hormone desirable to allow sugar (glucose) to come into cells to produce energy. Insulin-dependent diabetes is a syndrome of glucose homeostasis considered by autoimmune destruction of the insulin-producing pancreatic Beta-cell that gradually leads to insulin deficiency and subsequent hyperglycemia. As there is no perfect treatment for the management, Gplife Healthcare has thought of and developed
Sr. No.
Parameters
Conditions
Initial
40°C & 75% RH
40°C & 75% RH
40°C & 75% RH
0 Day
1 Month
2 Months
3 Months
1
Disintegration Time
200-240 sec
200-240sec
200-240sec
200-242 sec
2
Dissolution Time
45 minutes
45min
45min ± 0.01min
45 min ± 0.01 min
3
Average Weight
670 ± 5 mg
670 ± 5 mg
670 ± 5 mg
671 ± 5 mg
4
Friability
0.8981
0.8981
0.898
0.8979
Parameters
Formulation
F1
F2
F3
F4
F5
F6
F7
Hausner's ratio
1.28
1.36
1.29
1.24
1.15
1.35
1.40
Carr's index (%)
22.68
19.12
20.62
15.62
14.98
19.32
21.32
Angle of Repose
19.28
18.62
21.03
19.06
16.21
21.62
20.18
an Advance diabetic support product that is found to be very effective in the management of insulin-dependent diabetes. After 60 days of evaluation of many cases, it has been found that the fasting blood glucose levels are reduced by 62.25%, postprandial glucose levels are reduced by 62.37%, HBA1C levels are reduced by 39.57%, C Peptide levels are reduced by 69.23%, serum insulin levels are decreased by 88.57%. This case study gives an overview of the current understanding of the disease and the efficacy and safety of Advance diabetic support product in insulin-dependent diabetes. It is evident that the Advance diabetes support product further helps to reduce the insulin and OHA doses for the management of insulin-dependent diabetes It is suggested that the Advance diabetes support product should be further extensively used as a monotherapy or adjunctive therapy for the regulation or management or control of insulin-dependent diabetes. Gplife Healthcare Advance diabetic support product showed very promising results with respect to glycemic parameters like fasting glucose, PPBS, Insulin, and C-peptide in patients with insulin-dependent diabetes. It is evident that the Advance diabetes support product further helps to reduce the insulin and OHA doses for the management of insulin-dependent diabetes. It is suggested that the Advance diabetes support product should be further extensively used as a monotherapy or adjunctive therapy for the regulation or management or control of insulin-dependent diabetes
Table No: 08 Demographic data:
Parameter
Treatment
Group
Male (n=22)
Female(n=4)
Age (years)
50.41±17.62
49.75±24.39
Total Age (years)
50.31±18.23
A total of 26 cases are evaluated who have taken treatment of Advance diabetic support product of Gplife Healthcare for 60 days. Only those case are considered who has not missed the doses in the treatment duration. Out of 26 cases, 22 are male and 4 are females. Out of 26 cases, 5 are diagnosed with juvenile Diabetes having an age range of 13-22 years. The average age of 26 cases is found to be 50.41±17.62 for males and 49.75±24.39 for females.
Graph No: 01 Effect of Advance diabetic support product on Fasting Glucose Levels (FBG): FBS is evaluated in 26 cases who are treated with Advance diabetic support products for a period of 60 days. The initial mean FBS significantly reduced from 372.65±93.75 mg/dl to 204.65±39.60 after 30 days and to 140.69±28.20 after 60 days where p < 0.001 is found to be significant. In inference to the evaluation of the above parameters After 60 days, it has been found that the FBS levels are reduced by 45.08% after 30 days and 62.25% after 60 days
Graph No: 02 Effect of Advance diabetic support product on Post Prandial Glucose Levels (PPBS): PPBS is evaluated in 26 cases who are treated with Advance diabetic support products for a period of 60 days. The initial mean PPBS significantly reduced from 430.38±103.56 mg/dl to 299.08±34.01 after 30 days and to 161.96±19.04 after 60 days where p < 0.001 is found to be significant. In inference to the evaluation of the above parameters After 60 days, it has been found that the PPBS levels are reduced by 30.51% after 30 days and 62.37% after 60 days.
Table No: 09 Effect of Advance diabetic support product on HBA1c Levels
Duration
HBA1c Levels (Mean±SD) - mmol/mol
% Reduction
TEST
Baseline
11.75±2.22
-
Day 60
7.10±0.7
39.57%
P Value
<0.001
Data analyzed by student t test. Significant at p<0.05.
Graph No: 03 Effect of Advance diabetic support product on HBA1c Levels: HBA1c is evaluated in 26 cases who are treated with Advance diabetic support products for a period of 60 days. The initial mean value for HBA1c significantly reduced from 11.75±2.22 to 7.10±0.74 after 60 days where p < 0.001 is found to be significant. In inference to the evaluation of the above parameters After 60 days, it has been found that the HBA1c levels are reduced by 39.57% after 60 days.
Table No: 10 Effect of Advance diabetic support product on C-Peptide Levels
Duration
C- Peptide Levels (Mean±SD) - mmol/mol
% Reduction
TEST
Baseline
32.29±14.11
-
Day 60
9.71±3.55
69.23%
P Value
<0.005
Data analyzed by student t test. Significant at p<0.05.
Graph No: 04 Effect of Advance diabetic support product on C- Peptide Levels
C- Peptide Levels is evaluated in 26 cases who are treated with Advance diabetic support products for a period of 60 days. The initial mean value for C- Peptide Levels significantly reduced from 32.29±14.11 to 9.71±3.55 after 60 days where p < 0.005 is found to be significant. In inference to the evaluation of the above parameters After 60 days, it has been found that the C- Peptide Levels are reduced by 69.23% after 60 days.
Table No: 11 Effect of Advance diabetic support product on Insulin Levels
Duration
Insulin Levels (Mean±SD) - mIU/L
% Reduction
TEST
Baseline
22.96±13.86
-
Day 60
2.62±4.73
88.57%
P Value
<0.001
Data analyzed by student t-test. Significant at p<0.05.
Insulin Levels are evaluated in 26 cases who are treated with Advance diabetic support products for a period of 60 days. The initial mean value for Insulin Levels significantly reduced from 22.96±13.86 to 2.62±4.73 after 60 days where p < 0.001 is found to be significant. In inference to the evaluation of the above parameters After 60 days, it has been found that the insulin levels are reduced by 88.57% after 60
The findings of 15 clinical trials with GP Life Diabetes support product clearly indicated the beneficial effects in DM and related complications with additional advantage of long-term safety.
Table No 12: Glucose Fasting
Glucose Fasting (Mean±SD)
Duration
Test
Placebo
P value
Baseline
176.47±33.94
177.05±32.21
0.771
Day 90
127.92±13.67
160.13±29.10
Mean diff (Baseline – Day 90)
48.55±34.67
16.92±11.54
<0.001
% Reduction
27.51%
9.55%
P value
<0.001
<0.001
Analyzed by Wilcoxon signed rank test for within group analysis and Mann Whitney U test for between group analysis. Significant at p<0.05
There is 27.51 % significant reduction in treatment group compared to 9.55 % in placebo group.
Table No 13: Glucose PP
Glucose PP (Mean±SD)
Duration
Test
Placebo
P value
Baseline
221.52±29.95
224.56±31.40
0.544
Day 90
164.59±14.03
213.23±26.50
Mean diff (Baseline – Day 90)
56.93±33.88
11.33±23.57
<0.001
% Reduction
25.69%
5.04%
P value
<0.001
<0.001
Data analyzed by student t test. Significant at p<0.05
There is 25.69 % significant reduction in treatment group compared to 5.04 % in placebo group.
Table No 14: HbA1c
HbA1c (Mean±SD)
Duration
Test
Placebo
P value
Baseline
8.93±0.99
8.53±1.13
0.023
Day 90
6.80±0.73
8.00±1.08
Mean diff (Baseline – Day 90)
2.13±0.98
0.53±0.79
<0.001
% Reduction
23.85%
6.21%
P value
<0.001
<0.001
Data analyzed by student t test. Significant at p<0.05
There is 23.850% significant reduction in treatment group compared to 6.21 % in placebo group.
Table No 15: HOMA IR:
HOMA-IR (Mean±SD)
Duration
Test
Placebo
P value
Baseline
7.97±2.54
7.66±1.73
0.384
Day 90
7.42±2.17
7.31±1.03
Mean diff (Baseline – Day 90)
0.55±2.25
0.36±1.59
0.539
% Reduction
6.90%
4.56%
P value
0.036
0.055
Data analyzed by student t test. Significant at p<0.05
The HOMA-IR score reduced by 6.90% in treatment group while in placebo group it reduced by 4.56%
Table No 16: HOMA-B:
HOMA-B (Mean±SD)
Duration
Test
Placebo
P value
Baseline
34.97±11.15
34.62±12.82
0.855
Day 90
64.02±20.44
41.60±16.22
Mean diff (Baseline – Day 90)
29.04±23.29
-6.99±9.57
<0.001
% Reduction
-83.07%
-20.16%
P value
<0.001
<0.001
Data analyzed by student t test. Significant at p<0.05
The HOMA-B score increased by 83.07% in treatment group while in placebo group it increased by 20.16%
Table No 17: DEMOGRAPHIC DETAILS:
Parameter
Treatment
Placebo
Group
Male (n=52)
Female(n=23)
Male(n=44)
Female(n=31)
Age (years)
49.77±12.44
53.48±9.99
47.70±10.82
51.29±9.64
Total Age (years)
51±12
49±10
In the present study the mean age of male and female subjects in treatment and placebo groups are comparable and ranged from 49 to 51 years.
Effect on level of Insulin
Insulin Increased by 3 times in comparison with the diabetic control group.
The mean plasma insulin level of diabetic rats is significantly decreased compared to the basal level. But in the GP LIFE’S DIABETIC SUPPORT PRODUCT group increase in the mean plasma insulin levels increased significantly after 28 days.
Effect on level of interleukin-6
Interleukin-6 decreased by 52% in comparison with the diabetic control group. streptozotocin damages pancreatic ß cells, hyperglycemia which eventually leads to the release of pro-inflammatory cytokines in response to pancreatic necrosis. The streptozotocin group recorded a significantly higher level of interleukin-6compared to normal Animals at the experimental. Treatment of diabetic animals with Diabetic Support Product reduced the level of interleukin-6 significantly compared to diabetic animals. In the present study due to the treatment of GP LIFE’S DIABETIC SUPPORT PRODUCT, there is the restoration of beta cells due to a reduction in inflammation mediated by interleukin-6.
Effect on levels of interleukin-1ß : Interleukin-1ß decreased by 73% in comparison with the diabetic control group. Streptozotocin diabetic Animals displayed a significantly higher level of IL-1ß compared to normal Animals. Treatment with Diabetic Support Product significantly decreased the level of IL-1ß compared with diabetic Animals. Interleukin 1Beta (IL1ß) is the cytokine with the potential to destroy the islet of pancreases which has been observed in the diseases group but in the Treatment group, less amount of Interleukin 1Beta (IL1ß) is detected and leads toward the regeneration of new beta cell
Effect on levels of interferon-?: Interferon-? decreased by 28% Than in the diabetic control group.
IFN-? production is significantly increased in streptozotocin-diabetic Animals compared to normal Animals, recording the highest percentage of increase. Treatment of Streptozotocin diabetic
Animals with Diabetic Support Product caused a significant reduction in the levels of IFN-? compared to normal Animals. These results highlight evidence of the pronounced impact of IFN-? production on the ß cell destruction pathway i.e., low levels of IFN-? suggest that B cell protection activity of GP LIFE’S DIABETIC SUPPORT PRODUCT.
HISTOPATHOLOGY: There is an increase in the number of islets in GP LIFE’S DIABETIC SUPPORT PRODUCT-treated diabetic rats when compared to untreated diabetic control. It has been noted all the test compounds mitigate the inflammatory, degenerative, atrophic effect Islet of Langerhans. These lesions along with loss of Islet of Langerhans are reduced in the treated group which could be due to mitigatory action of the test drug and/or efficacy of the test drug to regenerate cells of Islet of Langerhans. Streptozotocin-induced untreated diabetic rats showed extensive destruction of islet cells as compared with the sections of the pancreas of healthy control rats. Further, there is a definite reduction in the number of islets in diabetic rats, compared to healthy rats.
Signs of regeneration of ß cells, potentiation of insulin secretion from surviving ß cells of the islets of Langerhans, and a decrease in blood glucose have been reported after treatment of GP LIFE’S DIABETIC SUPPORT PRODUCT.
These results indicate that individual treatment with Gplife’s Diabetes Support Product can po
The histologic feature of islets from the pancreas of diabetic animals is characterized by a severe decrease in the number of islets, inflammation, vacuolation of the islets, and degranulation of the beta cells. In addition, the regular arrangement of alpha and beta cells is disturbed and clumping of beta cells, pyknosis, and necrosis are seen in the islets.
Formalin-fixed samples of the pancreas are received. These tissues are trimmed longitudinally and routinely processed. Tissue processing is done to dehydrate in ascending grades of alcohol, clear in xylene, and embedded in paraffin wax. Paraffin wax embedded tissue blocks are sections at 3 µm thickness with the Rotary Microtome. All the slides of the pancreas are stained with Haematoxylin & Eosin (H & E) stain sitively influence b-cell function and beta-cell regeneration in rodents.
Purpose behind this invention is to convert excipientless precise dose made up without excipient, enhancing therapeutic action with elimination of side effects. Screening of several phytoconstituents/phytochemicals leading to formation of statistically design synergic components with improved dosage evaluation parameters, therapeutically efficacy and potency.
Synergic blend is produced without adding chemical based preservative, excipients, additives, and dosage modifying agent executing synergic therapeutic effect. Also, aqueous transparent coating ,CLAIMS:An herbal composition comprising synergistic phytoconstituents blend in treatment in to effective management of the diabetes in human.
2. The herbal composition as claimed in claim 1, wherein the synergistic phytoconstituents blends of extract of Gymnema Sylvestre (Gudmar), Trigonella Foenum-Graecum (Methi), Cinnamomum verum (Cinnamon), Curcuma longa (Curcumin), Andrographis paniculata (Kalmegh), Salacia Oblonga (Saptarangi) to effectively treat the diabetes in human.
3. The herbal composition as claimed in claim 1, wherein the process for preparation of composition comprising phytoconstituents without chemical excipients.
4. The herbal composition as claimed in claim 1, wherein the synergistic phytoconstituents blends of extract of Gymnema Sylvestre (Gudmar), Trigonella Foenum-Graecum (Methi), Cinnamomum verum (Cinnamon), Curcuma longa (Curcumin), Andrographis paniculata (Kalmegh), Salacia Oblonga (Saptarangi).
5. The herbal composition as claimed in claim 1, wherein the synergistic phytoconstituents blends of extract of Gymnema Sylvestre 450mg, Trigonella Foenum-Graecum 70mg, Cinnamomum verum 60mg, Curcuma longa 50mg, Andrographis paniculata 10mg, Salacia Oblonga 30mg