A clinical trial to study the effects of ZYH1 and Pioglitazone in patients with high lipid levels and impaired glucose tolerance test.

A 12 week, randomized, double blind parallel group prospective dose ranging study of ZYH1 with an open pioglitazone arm to evaluate the efficacy on dyslipidemia in patients with Impaired Glucose tolerance Test. - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000167

Enrollment

Registered

2010-03-09

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

Health Condition 1: null- Dyslipidemia with Impaired Glucose Tolerance Test

Interventions

Intervention1: ZYH1 0.5mg, 1mg, 2mg and 4mg : one tablet once daily of either 0.5mg, 1mg, 2mg or 4mg in the morning for the entire duration of the study i.e. for 12 weeks. Control Intervention1: Piog

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex ï?³18 years of age. Established diagnosis of dyslipidemia with BMI 23-42kg/m2 with fasting triglyceride level ï?³ 150mg/dL. Fasting Plasma Glucose less than126mg/dL and Oral Glucose Tolerance test between 140-200 mg/dL (According to American Diabetes Association) Normal routine haematological and biochemical test results. Informed consent of the patient / relative.

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to sulpha drugs or ZYH1. 2.Pregnancy & Lactation. 3.Patients with active liver disease or hepatic dysfunction indicated by AST or ALT levels > or = 2.5 times the upper limit of normal. 4.Patients with history of myopathy or evidence of active muscle disease. 5.Haemoglobin less than 11mg% 6.Patients on concomitant medications known to affect lipid levels and glucose levels and do not want to enter in wash out period. 7.Patients with any other serious concurrent illness or malignancy. 8.Presence or history of gallstone. 9.Patients with continuing history of alcohol and / or drug abuse. 10.Participation in another clinical trial in the past 3 months

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose.Timepoint: From baseline, visit 2(Week 0)to visit 8 (Week 12)	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP)Timepoint: From baseline, visit 2 (Week 0)to visit 8 (Week 12).	—

Countries

India

Contacts

Public ContactDr RH Jani

Cadila Healthcare limited

rhjani@zyduscadila.com91-22-26186052

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026