Viewing Study NCT06487598



Ignite Creation Date: 2024-07-17 @ 11:30 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06487598
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-07-05
First Post: 2024-06-27

Brief Title: To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients RCTNA
Sponsor: Hirabai Cowasji Jehangir Medical Research Institute
Organization: Hirabai Cowasji Jehangir Medical Research Institute

Study Overview

Official Title: 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
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Type-I diabetes mellitus T1DM is an autoimmune condition in which the pancreas reducesstops insulin production Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation In India approximately 86 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 andor 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 andor increased insulin secretion

In Ayurveda the combination of turmeric haridra and amla amalaki is strongly recommended for Prameha Diabetes mellitus
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None