This is a multicenter study wherein the efficacy and safety of standardized 10% β â??glucogallin Saberry (an extract of amla) will be studied against Metformin in newly diagnosed adult male or female patients with Type 2 Diabetes mellitus associated with abnormal amount of lipids in the blood.

Not Applicable

• Conditions: Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications

• Registration Number: CTRI/2019/11/021992
• Lead Sponsor: Sami Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male and female of 30 to 65 years old inclusive of both.

2.Body Mass Index (BMI) range 27to 35 kg/m2.

3.Females with child bearing potential who agree to use barrier method of contraception throughout the study period.

4.Newly Diagnosed of Type 2 Diabetes (T2DM) and is drug naive with FBS >130 mg/dL; PPBS >210mg/dL; HbA1c >6.5%.

5.Lipid parameters: Total Cholesterol >200mg/dL,

Triglyceride >160 mg/dL, LDL >140 mg/dL.

6.Patients willing to follow suggested diet and a physical activity by the study doctor for a minimum of 30 min for 5 days in a week.

7.Patients must be willing to come for regular follow-up visits.

8.Willing to sign informed consent.

Exclusion Criteria

1.Pregnant and lactating female and having the intention to be pregnant within next three months.

2.History of Smoking & Alcohol intake (within 3 months before screening).

3.Type 1 diabetes.

4.With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance.

5.Use of any lipid-lowering therapies in the past 3 months.

6.Patient with TG > 300 mg/dL, LDL > 200 mg/dL, Total cholesterol > 300 mg/dL FBS > 150 mg/dL and PPBS > 300 mg/dL.

7.Patients with HbA1C > 9.0 % (9.1% excluded)

8.Patient on antihypertensive medication.

9.Patient with history of clinically significant thyroid disorder (hypo or hyper), gastrointestinal, cardiovascular, haematological, hepatic (SGOT or SGPT levels > 3 Upper Limit of Normal), renal (serum creatinine >= 1.3 mg/dl), respiratory, active malignancy or genitourinary abnormalities or diseases.

10.A history of significant multiple and/or severe allergies or anaphylactic reactions.

11.Patient with known history of hypersensitivity to the investigational product.

12.Patient has participated in any clinical trial within last 3 months.

13.Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean % percentage change in HbA1c from screening to final visit. <br/ ><br>2. Mean change in fasting plasma glucose and post prandial plasma glucose from screening to final visit.Timepoint: 1. Mean % percentage change in HbA1c (Screening and Day90). <br/ ><br>2. Mean change in fasting plasma glucose and post prandial plasma glucose (Screening,Day30,Day60 and Day90).

Secondary Outcome Measures

Name	Time	Method
1.Mean change in Lipid Profile from screening to final visit. <br/ ><br>2.To compare the mean change in HbA1c, fasting plasma glucose, post - prandial plasma glucose and lipid profile with 1gm/day & 2gm/day dose of Saberry® tablets. <br/ ><br>3.Changes in weight and BMI. <br/ ><br>4.Assessment of Adverse EventsTimepoint: 1.Mean change in Lipid Profile(Screening, Day30,Day60 and Day90). <br/ ><br>2.To compare the mean change in HbA1c, fasting plasma glucose, post - prandial plasma glucose with 1gm/day & 2gm/day dose of Saberry® tablets(Screening, Day30, <br/ ><br>Day60 and Day90). <br/ ><br>3.Changes in weight and BMI(Screening and Day90). <br/ ><br>4.Assessment of Adverse Events(Day30,Day60 and Day90).