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Active, Not Recruiting

NCT Number: NCT06487598

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inj insulin to one group

Drug

One group- only inj insulin for 3 months.

Other names: Inj Insulin

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

Primary outcomes

  1. Glycemic control (HbA1c)

    Time frame: 3 months

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

  2. 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.

Secondary outcomes

  1. Change in urinary parameter.

    Time frame: 3 months

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

  2. Change in blood parameter-lipid profile.

    Time frame: 3 months

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

  3. Change in Fat (%)

    Time frame: 3 months

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

  4. Change in Body composition.

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Hirabai Cowasji Jehangir Medical Research Institute

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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