A clinical study of BGR 34, in patients with type 2 diabetes mellitus.

Controlled clinical study of an Ayurvedic anti diabetic formulation (BGR-34) for its efficacy and safety in patients with type 2 Diabetes mellitus - CASE

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/11/007476

Enrollment

Registered

2016-11-23

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 2 Diabetes Mellitus.

Interventions

Intervention1: BGR-34: Dose:two tablet of 620 mg frequency:twice a day before meals. route of administration:oral Control Intervention1: TRIPHALA as placebo: dose: two tablets of 620 mg (containing 2

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 Diabetes mellitus Fasting blood glucose >126 mg/dL Absence of any other significant disease or clinically significant medical history on physical examination during screening in the view of the investigator. Subjects willing to provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients on Insulin Patients with acute infections or chronic debilitating diseases, tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs Pregnancy and lactation Patients diagnosed with severe end organ damage Unwillingness to give written informed consent for participation in the study.

Design outcomes

Primary

Measure	Time frame
Assessment has been done on the basis of specially prepared performa for assessing blood sugar fasting and blood sugar post parandial blood sugar on days 0,30,60,90,120 and for HbA1c it is 0 and 120.Timepoint: Time point of days for blood sugar fasting and blood sugar post parandial blood sugar: 0,30,60,90,120 Time point of days for HbA1c: 0; 120 Time point of days for change in patient reported diabetes symptoms: polyuria, nocturia, polyphagia, polydispia, pain calf muscle, burning sensations of soles and palm, general fatigue, loss of weight, decreased libido, itching on genital, blurred vision delayed healing of wound and quality of life at: 0,30,60,90,120 days.	—

Measure

Time frame

Assessment has been done on the basis of specially prepared performa for assessing blood sugar fasting and blood sugar post parandial blood sugar on days 0,30,60,90,120 and for HbA1c it is 0 and 120.Timepoint: Time point of days for blood sugar fasting and blood sugar post parandial blood sugar: 0,30,60,90,120 Time point of days for HbA1c: 0; 120 Time point of days for change in patient reported diabetes symptoms: polyuria, nocturia, polyphagia, polydispia, pain calf muscle, burning sensations of soles and palm, general fatigue, loss of weight, decreased libido, itching on genital, blurred vision delayed healing of wound and quality of life at: 0,30,60,90,120 days.

—

Secondary

Measure	Time frame
Assessment was done on the basis of specially prepared performa for assessing relating parameters indicating safety and additional details.Timepoint: 120 days	—

Countries

India

Contacts

Public ContactDr BP Gupta

Aggarwal Dharmath Hospital society registered

adhs_r@yahoo.co.in9313291669

Outcome results

None listed

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