Health Condition 1: E70-E88- Metabolic disorders
Conditions
Interventions
Intervention1: CLV-0025P: Oral administration of
CLV-0025P for 84 days
Control Intervention1: Active Control: Oral administration of active control 84 days
Sponsors
Akay Natural Ingredients Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pre-diabetes subjects 30 (FBS: 100-125 mg/dL or PPBS: 140-199 mg/dL and Hb1Ac: 5.7â??6.4%) 2. Subjects with two or more of following metabolic health risk factors Dyslipidaemia - TG > 150 mg/dL or HDL Cholesterol Hypertension(Blood pressure >= 130 / 85 and On stable hypertensive treatment since past 2 months Overweight or obese (BMI >= 25 kg/m2 ) Abdominal obesity ( > 90 cm ( > 35 inch) in men and > 80 cm ( > 32 inch) in women ) 3. Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study 5.Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Type 1 and 2 diabetes mellitus or secondary diabetes mellitus 2. Subjects having symptoms of viral infection, including COVID-19 infection 3. Abnormal haematological or biochemical parameters other than specified in the inclusion criteria 4. Subjects who are on parental insulin, statins or any other lipid lowering drugs 5. Subjects on other therapies such as homeopathy / Ayurveda etc for treating above mentioned conditions 6. Subjects allergic to herbal products or any component of the study product 7. Known HIV or Hepatitis B positive or any other immuno-compromised state 8. History of Uncontrolled hypertension, Coronary artery disease, Angina, tread mill test (TMT) positive for inducible ischemia, Chronic metabolic disease, Psychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery, Surgery of oesophagus, stomach or duodenum, bariatric surgery Any acute gastrointestinal disorder within 2 weeks prior to study entry 9. Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation 10. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 11. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the metabolic health risk factors.Timepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in oxidative stress, inflammatory and immunity markersTimepoint: Day 0, Day 42, Day 84;Improvement in Quality of lifeTimepoint: Day 0, Day 42, Day 84;Safety of Test FormulationsTimepoint: Day 0, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed