A clinical trial to assess safety and efficacy of new formulation (NIA/DG-04) in Type 2 Diabetes Mellitus

Safety and Efficacy of Novel Preparation NIA/DG-04 in patients of Madhumeha with special reference to Type 2 Diabetes Mellitus : Proof of Concept Clinical Study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041358

Enrollment

Registered

2022-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in the age group of 30-60 years. 2. Patients with Fasting Blood Sugar (FBS) above 126 mg/dl, Post Prandial Blood Sugar (PPBS) above 140 mg/dl. 3. Type 2 Diabetes Mellitus 4. Presence of cardinal symptoms of Madhumeha as described in Ayurvedic texts.

Exclusion criteria

Exclusion criteria: 1. Patients of Type 1 Diabetes Mellitus 2. Patients of Type 2 Diabetes Mellitus who are on insulin therapy. 3. Patients having any serious illness like coronary artery disease, malignancy, kidney failure, and diabetic complications like neuropathy etc. 4. Impaired values of LFT, RFT 5. Pregnant women and lactating mother.

Design outcomes

Primary

Measure	Time frame
Changes in Blood glucose level (Fasting and Post Prandial)Timepoint: 30 days	—

Secondary

Measure	Time frame
Changes in Madhumeha lakshana scoring, changes in Triglyceride, HDL and LDL cholesterol level, BMI.Timepoint: 30 days	—

Countries

India

Contacts

Public ContactDr Bhawna

National institute of Ayurveda Jaipur

sumitnathani2@rediffmail.com7665809886

Outcome results