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

Not Applicable
Active, not recruiting
Conditions
Type 1 Diabetes
Interventions
Drug: inj insulin to one group
Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
Registration Number
NCT06487598
Lead Sponsor
Hirabai Cowasji Jehangir Medical Research Institute
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria
  1. K/C/O type-I DM for more than 1 year
  2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
  3. Parents provide consent and children providing assent for the study
Exclusion Criteria
  1. K/C/O type-I DM for more than 1 year
  2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
  3. Parents provide consent and children providing assent for the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm1-Only insulin treatment for type 1 Diabetes patientsInj Insulin with Tab Nisha-Amalaki 500 mg twice a dayArm1:-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.
Arm2-Insulin with Nisha-Amalaki tabletsinj insulin to one groupArm2:-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.
Arm1-Only insulin treatment for type 1 Diabetes patientsinj insulin to one groupArm1:-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.
Arm2-Insulin with Nisha-Amalaki tabletsInj Insulin with Tab Nisha-Amalaki 500 mg twice a dayArm2:-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.
Primary Outcome Measures
NameTimeMethod
Change in a insulin dose3 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)3 months

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

Secondary Outcome Measures
NameTimeMethod
Change in urinary parameter.3 months

Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg)

Change in Fat (%)3 months

Change in Body composition by using Bioelectrical Impedance Analysis(BIA)

Change in Body composition.3 months

Change in fat mass ( kg) by using Bioelectrical Impedance Analysis(BIA)

Change in blood parameter-lipid profile.3 months

Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl)

Trial Locations

Locations (1)

Hirabai Cowasji Jehangir Medical Research Institute

🇮🇳

Pune, Maharashtra, India

Hirabai Cowasji Jehangir Medical Research Institute
🇮🇳Pune, Maharashtra, India

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