Safety and Efficacy of Beta Amyrin Palmitate in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidaemia.

Phase 3

Completed

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

• Registration Number: CTRI/2023/09/058019
• Lead Sponsor: Sam Sabinsa Group Limited

Brief Summary

The study involves 30 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either Beta Amyrin Palmitate or Placebo (Microcrystalline Cellulose). Specific biomarkers like fasting blood sugar, serum insulin, HbA1c will be measured and analysed during the study period. The final statistical analysis and study report will be complied at the end of the study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-30
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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 between 126 to 210 mg/dL, PPBS between 200 to 300 mg/dL and 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 and LDL between 120 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.
• Patients 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 has 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 the study.
• A history of significant multiple and/or severe allergies or anaphylactic reactions.
• Patient with known history of hypersensitivity to the investigational product.
• Participant who has participated in any clinical trial within the last 3 months.
• Any other condition that the Principal Investigator thinks may jeopardize the study.
• Any other reason(s) as per principal investigator discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Beta Amyrin Palmitate on blood glucose level.	1. Screening to 90 days | 2. Screening to 90 days
1. Mean change in HbA1c from screening to final visit.	1. Screening to 90 days | 2. Screening to 90 days
2. Mean change in fasting blood glucose & postprandial blood sugar from screening to final visit.	1. Screening to 90 days | 2. Screening to 90 days

Secondary Outcome Measures

Name	Time	Method
To compare Mean change in lipid profile- Triglycerides, low density lipid, very low-density lipid, high density lipid & total cholesterol.	2. To compare the mean change in HbA1c, Fasting Blood Glucose and Post-prandial blood sugar.

Trial Locations

Locations (2)

Nuha Hospitals; 🇮🇳 Guntur, ANDHRA PRADESH, India

Sapthagiri Institute of Medical Sciences and Research Center; 🇮🇳 Bangalore, KARNATAKA, India

Nuha Hospitals

🇮🇳Guntur, ANDHRA PRADESH, India

Dr Pradeep TVS

Principal investigator

9885411254

doctvspradeep@gmail.com