ß-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia

A randomized, double-blinded, double dummy, parallel, comparative study to evaluate the efficacy and safety of ß-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057969

Enrollment

Registered

2023-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants should be willing to give a written informed consent. 2.Participants should be willing to comply with the requirements of the trial/ study. 3.Male and female participants aged between 25-65 years. 4.Females with childbearing potential who agree to use a barrier method of contraception throughout the study period. 5.Participants, newly diagnosed with Type 2 Diabetes (T2DM) and is drug-naive with FBS between126 to 210 mg/dL PPBS between 200 to 300 mg/dL HbA1c between 6.5 to 8.9 %. 6.Lipid parameters: Total Cholesterol between 200 to 300 mg/dL, Triglyceride between 160 to 300 mg/dL, LDL between120 to 200 mg/dL. 7.Ability to swallow and retain oral medications as per the protocol.

Exclusion criteria

Exclusion criteria: 1. History of Smoking and Alcohol intake (within 3 months before screening) 2. Type-1 Diabetes 3. Presence of chronic gastrointestinal diseases, severe immune deficiencies, lactose intolerance. 4. Use of any lipid lowering therapies in the past 3 months. 5. Patient on antihypertensive medications. 6. Patient with history of clinically significant thyroid disorder, gastrointestinal, cardiovascular, haematological, hepatic, renal, respiratory, active malignancies or genitourinary abnormalities or diseases. 7. Patient who have participated in any clinical trial within the past 3 months. 8. Pregnant and lactating women and those not willing to follow a reliable and effective contraceptive measure during the study. 9. Any planned surgery during study.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of beta –amyrin Palmitate with Activated Curcumin Complex (AC3) combination on blood glucose level. 1. Mean percentage change in HbA1c from screening to final visit. 2. Mean change in fasting blood glucose & postprandial blood sugar from screening to final visit.Timepoint: 1. Screening to 120 days 2. Screening to 120 days	—

Secondary

Measure	Time frame
1. To compare Mean change in lipid profile –TG, LDL, VLDL, HDL, & TC. 2. To compare the mean change in HbA1c, fasting blood glucose and post-prandial blood sugar between active and reference arm. 3. To compare the area under curve (AUC) in serum insulin between active and reference arm. 4. Safety is determined based on the tolerance to amyrin Palmitate with Activated Curcumin Complex (AC3) capsule without any incidence of adverse events. Study Compliance without drop-outs. No adverse change in Complete Blood Count, Urine Routine & Microscopic, Blood chemistry, and incidence of any adverse events during the study period in both the arms.Timepoint: 1. Screening to 120 days 2. Screening to 120 days 3. Day-1 to 120 days 4. Screening to 120 days	—

Measure

Time frame

1. To compare Mean change in lipid profile –TG, LDL, VLDL, HDL, & TC. 2. To compare the mean change in HbA1c, fasting blood glucose and post-prandial blood sugar between active and reference arm. 3. To compare the area under curve (AUC) in serum insulin between active and reference arm. 4. Safety is determined based on the tolerance to amyrin Palmitate with Activated Curcumin Complex (AC3) capsule without any incidence of adverse events. Study Compliance without drop-outs. No adverse change in Complete Blood Count, Urine Routine & Microscopic, Blood chemistry, and incidence of any adverse events during the study period in both the arms.Timepoint: 1. Screening to 120 days 2. Screening to 120 days 3. Day-1 to 120 days 4. Screening to 120 days

—

Countries

India

Contacts

Public ContactSatish G

Sami Sabinsa Group Limited

satish.g@clinworld.net08068527777

Outcome results