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Clinical Trials/NCT06487598
NCT06487598
Active, not recruiting
Not Applicable

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.

Hirabai Cowasji Jehangir Medical Research Institute1 site in 1 country70 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
inj insulin to one group
Conditions
Type 1 Diabetes
Sponsor
Hirabai Cowasji Jehangir Medical Research Institute
Enrollment
70
Locations
1
Primary Endpoint
Change in a insulin dose
Status
Active, not recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
July 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Anuradha Khadilkar

Consultant Pediatrician and Deputy Director

Hirabai Cowasji Jehangir Medical Research Institute

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Arm1-Only insulin treatment for type 1 Diabetes patients

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.

Intervention: inj insulin to one group

Arm1-Only insulin treatment for type 1 Diabetes patients

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.

Intervention: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day

Arm2-Insulin with Nisha-Amalaki tablets

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.

Intervention: inj insulin to one group

Arm2-Insulin with Nisha-Amalaki tablets

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.

Intervention: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day

Outcomes

Primary Outcomes

Change in a insulin dose

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.

Glycemic control (HbA1c)

Time Frame: 3 months

Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.

Secondary Outcomes

  • Change in urinary parameter.(3 months)
  • Change in Fat (%)(3 months)
  • Change in Body composition.(3 months)
  • Change in blood parameter-lipid profile.(3 months)

Study Sites (1)

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