A clinical trial to evaluate Anti diabetic potential of ARLPK01

A phase 2, randomized, double blind, parallel group placebo controlled single centric study to evaluate the anti-diabetic potential of ARLPK01 as an add on therapy with metformin in patients with type 2 diabetes mellitus.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005121

Enrollment

100

Registered

2014-10-20

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- Type II Diabetes mellitus

Interventions

Intervention1: ARLPK01: Oral route. 1000mg /twice daily. Duration - 6 months Control Intervention1: Metformin 1000 mg/twice a day: 1000mg/ twice a day

Eligibility

Inclusion criteria

Inclusion criteria: Both gender Age 30-55 years. Patients whose duration of Type 2 Diabetes mellitus for 0-8years. Patients with stable dose of metformin for atleast 3 months. Patients with fasting glucose level Patients with HbA1c between 7.0-8.5 %. Patients ready to abide by trial procedures and to give informed consent.

Exclusion criteria

Exclusion criteria: Type 1 Diabetes mellitus and Gestational Diabetes Mellitus. Patients with HbA1c more than 8.5 %. Complications of diabetes such as Diabetic retinopathy, Diabetic Neuropathy and Diabetic Nephropathy. Patients with Cardiovascular Disorders, kidney and liver complications Ischemic heart disease with any cardiac event in last 6 months. Patients who are likely to undergo surgery during the study period. Patients who have participated in any investigational study in the last 8 weeks. Patients having known hypersensitivity to the study drugs and Patients with any severe infection . Patients with a history of intake of any Ayurvedic /herbal/homeopathic or any alternative therapies in the last one month. Pregnant or lactating females. Any clinical relevant abnormal physical or laboratory findings at the screening examination as judged by the investigator which would interfere with the objectives of the study.

Design outcomes

Primary

Measure	Time frame
Change in the beta cell regeneration. Change in the glycosylated haemoglobin (HbA1c) levels from the base line to end of the treatment. Timepoint: 12months	—

Secondary

Measure	Time frame
Change in the fasting and post prandial glucose levels from the base line to the end of the treatment. Number of patients who have achieved the glycosylated haemoglobin (HbA1c) less than 7. To compare the mean change of complete lipid profile (triglycerides, HDL, LDL, total cholesterol) from base line to end of the treatment between the treatment groups. Determination of Insulin sensitization activity . Comparison of Adverse event profile between the treatment groups. Timepoint: 12 months	—

Measure

Time frame

Change in the fasting and post prandial glucose levels from the base line to the end of the treatment. Number of patients who have achieved the glycosylated haemoglobin (HbA1c) less than 7. To compare the mean change of complete lipid profile (triglycerides, HDL, LDL, total cholesterol) from base line to end of the treatment between the treatment groups. Determination of Insulin sensitization activity . Comparison of Adverse event profile between the treatment groups. Timepoint: 12 months

—

Countries

India

Contacts

Public ContactDrSubashri Beulah

Arvind Remedies ltd

dr.suba_priya@yahoo.com044-27662144

Outcome results

None listed

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