To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)
- Conditions
- Type 1 Diabetes
- Interventions
- Drug: inj insulin to one groupDrug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
- Registration Number
- NCT06487598
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- K/C/O type-I DM for more than 1 year
- Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- Parents provide consent and children providing assent for the study
- K/C/O type-I DM for more than 1 year
- Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- Parents provide consent and children providing assent for the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm1-Only insulin treatment for type 1 Diabetes patients Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months. Arm2-Insulin with Nisha-Amalaki tablets inj insulin to one group Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months. Arm1-Only insulin treatment for type 1 Diabetes patients inj insulin to one group Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months. Arm2-Insulin with Nisha-Amalaki tablets Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months.
- Primary Outcome Measures
Name Time Method 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.
Glycemic control (HbA1c) 3 months Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.
- Secondary Outcome Measures
Name Time Method Change in urinary parameter. 3 months Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg)
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)
Change in blood parameter-lipid profile. 3 months Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl)
Trial Locations
- Locations (1)
Hirabai Cowasji Jehangir Medical Research Institute
🇮🇳Pune, Maharashtra, India
Hirabai Cowasji Jehangir Medical Research Institute🇮🇳Pune, Maharashtra, India