Study of an Ayurvedic Formulation Limit for safety and efficacy in type 2 diabetic patients with secondary failure to oral hypoglycemic drugs

Evaluation of Safety and Efficacy of Limit, an Ayurvedic formulation: A double blind, placebo controlled study in type 2 diabetic patients with Secondary failure to Oral drugs

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000656

Enrollment

Registered

2009-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Limit (Ayurvedic formulation): 3g/day, 3 months Control Intervention1: Corn starch: 3g/day, 3 months

Eligibility

Inclusion criteria

Inclusion criteria: Patients within the age range of 30 ? 60 years and should have secondary failure to OHA. Secondary failure to OHA was diagnosed if the patient had HbA1c levels > 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day.

Exclusion criteria

Exclusion criteria: Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency.

Design outcomes

Primary

Measure	Time frame
Antidiabetic activityTimepoint: 3 months	—

Secondary

Measure	Time frame
Improvement in metabolic, liver and kidney function tests, Insulin level, Hb A1c level.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactJayavant M Jain

NMIMS Deemed to be University

satishb9@gmail.com02563286545

Outcome results