Health Condition 1: -
Conditions
Interventions
Intervention1: Intervention arm 1: Nigellin�® ONYX Capsule
: Frequency: one capsule twice a day after food for 90 days.
Intervention2: Intervention arm 2: Nigellin�® PEARL Capsule: Frequency: on
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 ââ?°Â¥ 100 mg/dL 3.Hypertension with systolic blood pressureââ?°Â¥140 mm Hg or diastolic blood pressureââ?°Â¥90 mm Hg. 4.Patients with any one of the two criteriaââ?¬•s as below Fasting total triglycerides ââ?°Â¥150 mg/dL. HDL cholesterol: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Mean change in fasting blood sugar concentration ââ?¬Â¢ Change in blood pressureTimepoint: ââ?¬Â¢ screening to Day 90 ââ?¬Â¢ base line to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Mean change in lipid parameters ââ?¬Â¢ Mean change in HbA1c ââ?¬Â¢ Mean change in serum Insulin level ââ?¬Â¢ Mean change in Insulin Resistance (HOMA-IR) ââ?¬Â¢ Mean change in hsCRP and adiponectin ââ?¬Â¢ Mean change in waist circumference ââ?¬Â¢ Mean reduction in body weight ââ?¬Â¢ Change in WHO- Quality of Life Questionnaire ââ?¬Â¢ Safety of NigellinÃ?® by the occurrence of AE and clinically significant changes in laboratory parameters Timepoint: 1. screening to Day 90 2. screening to Day 90 3. baseline to Day 90. 4. Baseline to Day 90 5. baseline to Day 90 6. baseline to Day 90 7. screening to Day 90 8. baseline to Day 90 | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
Sami-Sabinsa Group Limited
Outcome results
None listed