A clinical study to assess the safety and efficacy of CLV 0025P in Subjects Having Metabolic disorders.
- Conditions
- Health Condition 1: E70-E88- Metabolic disorders
- Registration Number
- CTRI/2020/10/028577
- Lead Sponsor
- Akay Natural Ingredients Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 < 40 mg/dL (in men) and < 50 mg/dL (in women)
Hypertension(Blood pressure >= 130 / 85 and
<140/90 mm Hg )
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the metabolic health risk factors.Timepoint: Day 0, Day 42, Day 84
- Secondary Outcome Measures
Name Time Method 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