To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)

NCT06487598 | Active Not Recruiting

• 1 other identifier: JCDC/BHR/24/032
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes

Keywords

Type-I diabetes mellitus; Haridra; Amalaki; Prameh

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in urinary parameter.

  3 months

• Change in blood parameter-lipid profile.

  3 months

• Change in Fat (%)

  3 months

• Change in Body composition.

  3 months

Study Arms (2)

Arm1-Only insulin treatment for type 1 Diabetes patients

ACTIVE COMPARATOR

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.

Drug: inj insulin to one group; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day

Arm2-Insulin with Nisha-Amalaki tablets

ACTIVE COMPARATOR

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.

Drug: inj insulin to one group; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day

Interventions

inj insulin to one group DRUG

One group- only inj insulin for 3 months.

Also known as: Inj Insulin

Arm1-Only insulin treatment for type 1 Diabetes patients; Arm2-Insulin with Nisha-Amalaki tablets

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

second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day

Arm1-Only insulin treatment for type 1 Diabetes patients; Arm2-Insulin with Nisha-Amalaki tablets

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hirabai Cowasji Jehangir Medical Research Institute: lead

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatrician and Deputy Director

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)