Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, 411001, India
NCT Number: NCT06487598
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).
This study is active but is not currently recruiting participants.
10 year–18 year
All sexes
Interventional
Not applicable
Pune, Maharashtra, 411001, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One group- only inj insulin for 3 months.
Other names: Inj Insulin
second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
Time frame: 3 months
Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.
Time frame: 3 months
Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire.
Time frame: 3 months
Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg)
Time frame: 3 months
Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl)
Time frame: 3 months
Change in Body composition by using Bioelectrical Impedance Analysis(BIA)
Time frame: 3 months
Change in fat mass ( kg) by using Bioelectrical Impedance Analysis(BIA)
Hirabai Cowasji Jehangir Medical Research Institute
Other
Pilot Randomized Controlled Trial to Evaluate add-on Effect of Amalaki (Phyllantus Emblica) and Haridra (Curcuma Longa) Along With Insulin on Glycaemic Control in Patients With Type-I Diabetes Mellitus.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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