Type 1 Diabetes
Conditions
Keywords
Type-I diabetes mellitus, Haridra, Amalaki, Prameh
Brief summary
Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. In India, approximately 8.6 lakh people suffer from T1DM, and one in six young patients dies without a diagnosis. Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise. Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary. Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion. In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).
Interventions
DRUGinj insulin to one group
One group- only inj insulin for 3 months.
DRUGInj Insulin with Tab Nisha-Amalaki 500 mg twice a day
second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
Sponsors
Hirabai Cowasji Jehangir Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. K/C/O type-I DM for more than 1 year 2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status 3. Parents provide consent and children providing assent for the study
Exclusion criteria
1. K/C/O type-I DM for more than 1 year 2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status 3. Parents provide consent and children providing assent for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control (HbA1c) | 3 months | Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays. |
| Change in a insulin dose | 3 months | Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary parameter. | 3 months | Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg) |
| Change in blood parameter-lipid profile. | 3 months | Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl) |
| Change in Fat (%) | 3 months | Change in Body composition by using Bioelectrical Impedance Analysis(BIA) |
| Change in Body composition. | 3 months | Change in fat mass ( kg) by using Bioelectrical Impedance Analysis(BIA) |
Countries
India
Outcome results
None listed