Î²-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia

Phase 3

Completed

Conditions: Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Brief Summary: The study involves 96 subjects randomized in two arms and will receive 120 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either Beta-Amyrin Palmitate with activated curcumin complex (Arm-1) or Metformin-500mg (Arm-2) group. Specific biomarkers like fasting blood sugar, serum insulin, HbA1c will be measured and analysed during the study period. The final statical analysis and study report will be complied at the end of the study period.

Recruitment & Eligibility

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

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.
Use of any lipid lowering therapies in the past 3 months.
Patient on antihypertensive medications.
Patient with history of clinically significant thyroid disorder, gastrointestinal, cardiovascular, haematological, hepatic, renal, respiratory, active malignancies or genitourinary abnormalities or diseases.
Patient who have participated in any clinical trial within the past 3 months.
Pregnant and lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
Any planned surgery during study.

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of beta â€“amyrin Palmitate with Activated Curcumin Complex (AC3) combination on blood glucose level.	1. Screening to 120 days \| 2. Screening to 120 days
1. Mean percentage change in HbA1c from screening to final visit.	1. Screening to 120 days \| 2. Screening to 120 days
2. Mean change in fasting blood glucose & postprandial blood sugar from screening to final visit.	1. Screening to 120 days \| 2. Screening to 120 days

Secondary Outcome Measures

Name	Time	Method
1. To compare Mean change in lipid profile â€“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.

Locations (5): HandeHospital
🇮🇳
Chennai, TAMIL NADU, India
NRR Hospital
🇮🇳
Bangalore, KARNATAKA, India
NUHA Hospitals
🇮🇳
Guntur, ANDHRA PRADESH, India
Rajalakshmi Hospital
🇮🇳
Bangalore, KARNATAKA, India
StTheresasHospital
🇮🇳
Hyderabad, TELANGANA, India
HandeHospital
🇮🇳Chennai, TAMIL NADU, India
DrRaajiv Dorai
Principal investigator
9840036314
handehospital@yahoo.com