Clinical trial NCT06487598: To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type-I diabetes mellitus
Haridra
Amalaki
Prameh
Lead sponsor: Hirabai Cowasji Jehangir Medical Research Institute
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control (HbA1c)
timeFrame: 3 months
measure: Change in a insulin dose
timeFrame: 3 months
Secondary outcomes:
measure: Change in urinary parameter.
timeFrame: 3 months
measure: Change in blood parameter-lipid profile.
timeFrame: 3 months
measure: Change in Fat (%)
timeFrame: 3 months
measure: Change in Body composition.
timeFrame: 3 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Hirabai Cowasji Jehangir Medical Research Institute
state: Maharashtra
Study officials:
References: