Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
Conditions
Interventions
Intervention1: Standardized 10% β â??glucogallin (Saberry®) Tablet: Two tablets once a day orally after breakfast for 90 days.
Intervention2: Standardized 10% β â??glucogallin (Saberry®) Tablet: T
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean % percentage change in HbA1c from screening to final visit. 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). 2. Mean change in fasting plasma glucose and post prandial plasma glucose (Screening,Day30,Day60 and Day90). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in Lipid Profile from screening to final visit. 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. 3.Changes in weight and BMI. 4.Assessment of Adverse EventsTimepoint: 1.Mean change in Lipid Profile(Screening, Day30,Day60 and Day90). 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, Day60 and Day90). 3.Changes in weight and BMI(Screening and Day90). 4.Assessment of Adverse Events(Day30,Day60 and Day90). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed