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

Phase 3

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

• Registration Number: CTRI/2024/04/066012
• Lead Sponsor: All India Institute of Ayurveda, New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>6 <br/ ><br>th months and for the assessment in the present study.

Secondary Outcome Measures

Name	Time	Method
? Reduction in dose of insulin per day. <br/ ><br>25 <br/ ><br>? Relief in sign & symptoms of Sahaj Prameha. <br/ ><br>? Improvement in QOL of children with Type 1 Diabetes Mellitus <br/ ><br>Timepoint: 6 month