To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)
NCT Number: NCT06487598
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: DRUG: inj insulin to one group|DRUG: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
Sponsor: Hirabai Cowasji Jehangir Medical Research Institute
Sex: ALL
Age: CHILD, ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2025-07
Locations: Hirabai Cowasji Jehangir Medical Research Institute, Pune, Maharashtra, 411001, India

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).

Primary Outcome Measures: Glycemic control (HbA1c), Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays., 3 months|Change in a insulin dose, Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire., 3 months
Secondary Outcome Measures: Change in urinary parameter., Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg), 3 months|Change in blood parameter-lipid profile., Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl), 3 months|Change in Fat (%), Change in Body composition by using Bioelectrical Impedance Analysis(BIA), 3 months|Change in Body composition., Change in fat mass ( kg) by using Bioelectrical Impedance Analysis(BIA), 3 months