Efficacy and Safety Study of DyberineTM in Adult Subjects with Type 2 Diabetes Mellitus

An Open-labelled, Single Arm, Interventional Pilot Study to Evaluate the Efficacy and Safety of DyberineTM in Adult Subjects with Type 2 Diabetes Mellitus - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096063

Enrollment

Registered

2025-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Intervention1: Dyberine Powder: DyberineTM Powder 100 mg twice a day for 60 days Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex between the age group 18 to 65 years; Patients who are diagnosed with Type 2 Diabetes mellitus; Patients with HbA1c euals to 7 percent or more; Subjects with BMI more than 27 and less than 45; Women of childbearing potential must be willing to use double-barrier contraception for the entire study; Patients ready to abide by trial procedures and to give informed consent

Exclusion criteria

Exclusion criteria: Subjects with Type 1 diabetes mellitus, severe hyperglycemia FBS more than 240 or PPBS more than 360, fasting serum cholesterol more than 260 and serum Triglycerides more than 300; Subjects with BMI more than 45, and HbA1c more than 10.5; Subjects with severe renal, hepatic or respiratory disorder; Subjects with psychiatric, and hematological disorders; History of smoking more than 10 cigarettes per day or alcohol intake more than 30 ml per day; Subjects with Ischemic heart disease with any cardiac event in last 6 months; Participants who have participated in any investigational study in the last 4 weeks; Patients having known hypersensitivity to the study drugs; Patients with a history of intake of any Ayurveda, herbal, homeopathic, dietary supplements or any alternative therapies in the last one month; Pregnant or lactating females and women in child bearing age refusing to use of contraceptive methods

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from screening to end of study (Day 60)Timepoint: screening to Day 60	—

Secondary

Measure	Time frame
Change in fasting blood sugar (FBS); postprandial blood sugar (PPBS); body weight; BMI; waist circumference; Complete Blood Count (CBC); Liver Function Test (SGOT); Renal Function Test (Creatinine); Total Cholesterol and Triglycerides; clinical symptom scores; Incidence and severity of adverse eventsTimepoint: Day 60	—

Countries

India

Contacts

Public ContactMr Manik Chaudhuri

BIORADIAN LIFESCIENCE

amal.bioradian@gmail.com08697612674

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026