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

Hirabai Cowasji Jehangir Medical Research Institute

Status: Active, not recruiting

Conditions: Type 1 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06487598

JCDC/BHR/24/032

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Arm1-Only insulin treatment for type 1 Diabetes patients

Active Comparator group

Description:

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.

Treatment:

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

Drug: inj insulin to one group

Arm2-Insulin with Nisha-Amalaki tablets

Active Comparator group

Description:

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.

Treatment:

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

Drug: inj insulin to one group