Adjuvant Effect Of Nisha-Amlaki And Mahadadimadi Ghrita With Insulin In Diabetes Type I In Pediatric Population

A RANDOMIZED, OPEN LABEL, PLACEBO CONTROLLED STUDY TO EVALUATE THE ROLE OF TAB NISHA-AMALAKI AND MAHADADIMADI GHRITA AS ADJUVANT THERAPY IN TYPE 1 DIABETES (SAHAJA PRAMEHA) IN CHILDREN - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066012

Enrollment

Registered

2024-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E109- Type 1 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 02 -16 years. 2. Pre-diagnosed cases of T1DM (Type 1 diabetes) 3. Patients having FBS =126mg/dl, PPBS =200 mg/dl, HbA1c = 6.5% 4. Requirement of insulin as the initial mode of treatment at the time of diagnosis of diabetes. 5. Brittle diabetes (mellitus) 6. Diabetes (mellitus) due to autoimmune process 7. Diabetes (mellitus) due to immune mediated pancreatic islet beta-cell destruction 8. Idiopathic diabetes (mellitus) 9. Juvenile onset diabetes (mellitus)

Exclusion criteria

Exclusion criteria: 1. Patient age less than two year and more than 16 year 2. Patients of type 2 diabetes. 3. Any systematic and severe illness requiring hospitalization. 4. History of hypersensitivity to any drug. 5. Patients whose parents are not willing to give consent for clinical trial. 6. Active case of DKA and blood glucose level more than 600 mg/dl. 7. Ketosis-prone diabetes (mellitus), gestational diabetes. 8. Hyperglycemia NOS 9. Neonatal diabetes mellitus 10. Post pancreatectomy diabetes mellitus. 11. Post procedural diabetes mellitus. 12. Secondarydiabetes mellitus NEC.

Design outcomes

Primary

Measure	Time frame
Reduction in HBA1C, FBS, PPBS level and Serum InsulinTimepoint: FBS, PPBS level and Serum Insulin. Baseline, after every month and Hb1AC assessed Baseline, after 3rd month and 6 th months and for the assessment in the present study.	—

Secondary

Measure	Time frame
? Reduction in dose of insulin per day. 25 ? Relief in sign & symptoms of Sahaj Prameha. ? Improvement in QOL of children with Type 1 Diabetes Mellitus Timepoint: 6 month	—

Countries

India

Contacts

Public ContactDr Rajagopala S

All India Institute of Ayurveda New Delhi

srajagopala@gmail.com9893908190

Outcome results