Clinical Study to Evaluate the Efficacy and Safety of Black Cumin Seed Extract (Nigellin�®) in the Management of Metabolic Syndrome
- Conditions
- Health Condition 1: -
- Registration Number
- CTRI/2022/06/043240
- Lead Sponsor
- Sami Sabinsa Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult male and/or female participants between 18 to 65 years (both inclusive).
2.Newly diagnosed Type II Diabetes, having high blood sugar with fasting glucose � 100 mg/dL
3.Hypertension with systolic blood pressure�140 mm Hg or diastolic blood pressure�90 mm Hg.
4.Patients with any one of the two criteriaââ?¬•s as below
Fasting total triglycerides �150 mg/dL.
HDL cholesterol: < 40 mg/dL (Male), < 50 mg/dL (Female).
5.Agree to follow basic physical activity like walking for 30 min for 5 days in a week.
6.Participants willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol.
7.Willing to sign informed consent.
1.Pregnant and lactating female and having the intention to be pregnant within next three months.
2.Body Mass Index (BMI) > 35 kg/m2.
3.Females with reproductive potential who do not agree to use barrier method of contraception throughout the study period.
4.History of Smoking & Alcohol intake (within 3 months before screening).
5.On any special diet.
6.On special physical training regime like intense workout or gym.
7.Diagnosed with Type 1 diabetes.
8.With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance.
9.Use of any lipid-lowering therapies in the past 3 months.
10.Participants with HbA1c > 7%.
11.Participants with history of clinically significant or diagnosed with 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.
12.A history of significant multiple and/or severe allergies or anaphylactic reactions.
13.Participants with known history of hypersensitivity to the investigational product.
14.Participants who has participated in any clinical trial within last 3 months.
15.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 � Mean change in fasting blood sugar concentration <br/ ><br>� Change in blood pressureTimepoint: � screening to Day 90 <br/ ><br>� base line to Day 90
- Secondary Outcome Measures
Name Time Method â�¢ Mean change in lipid parameters <br/ ><br>â�¢ Mean change in HbA1c <br/ ><br>â�¢ Mean change in serum Insulin level <br/ ><br>â�¢ Mean change in Insulin Resistance (HOMA-IR) <br/ ><br>â�¢ Mean change in hsCRP and adiponectin <br/ ><br>â�¢ Mean change in waist circumference <br/ ><br>â�¢ Mean reduction in body weight <br/ ><br>â�¢ Change in WHO- Quality of Life Questionnaire <br/ ><br>â�¢ Safety of Nigellin�® by the occurrence of AE and clinically significant changes in laboratory parameters <br/ ><br>Timepoint: 1. screening to Day 90 <br/ ><br>2. screening to Day 90 <br/ ><br>3. baseline to Day 90. <br/ ><br>4. Baseline to Day 90 <br/ ><br>5. baseline to Day 90 <br/ ><br>6. baseline to Day 90 <br/ ><br>7. screening to Day 90 <br/ ><br>8. baseline to Day 90 <br/ ><br> <br/ ><br>