Health Condition 1: E70-E88- Metabolic disorders
Conditions
Interventions
Intervention1: MEET: Oral Administration of Single Dose of MEET for 180 days
Control Intervention1: Placebo: Oral Administration of Single Dose of Placebo for 180 days
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with any one of the metabolic health risk factors Dyslipidaemia( TG > 150 and HDL Cholesterol 129 and Total Cholesterol > 200 and = 126 mg/dL or PPBS: >= 200 mg/dL and Hb1Ac: > 6.5% On stable oral hypoglycaemic drugs since past three month) Hypertension(Controlled hypertension on stable hypertensive treatment since past 2 months) BMI (>= 25.00 to 102 cm ( > 40 inch) in men and > 88 cm ( > 35 inch) in women 2.Subject meeting all the laboratory parameters set forth to qualify to enrol in the study 3. Pre-frail (score: 6-7) and Frail (score: 8-11) subjects as per Edmonton Frail Scale 4. Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1 Type 1 diabetes mellitus or secondary diabetes mellitus 2 Abnormal haematological or biochemical parameters other than specified in the inclusion criteria 3 Subjects who are on parental insulin, statins or any other lipid lowering drugs 4 Subjects on other therapies such as homeopathy / Ayurveda, naturopathy etc for treating above mentioned conditions 5 Subjects allergic to herbal products or any component of the study product 6 Known HIV or Hepatitis B positive or any other immuno-compromised state 7. History of Uncontrolled hypertension, Coronary artery disease, Angina, tread-mill test positive for inducible ischemia, Chronic metabolic disease, Psychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Bariatric surgery, Eating disorder such as bulimia or binge eating, Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery, Surgery of oesophagus, stomach or duodenum, Any acute gastrointestinal disorder within 2 weeks prior to study entry 8 Subjects having haemoglobin level 9 Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude study participation 10 Non-Frail (score: 0-5) and severely frail (score: 12-17) subjects as per Edmonton Frail Scale 11 Currently participating or having participated in another clinical study during the last 3 months prior to the beginning of this study. 12 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 |
|---|---|
| Change in Efficacy parameters including frailty score,gait speed and muscle strengthTimepoint: Day 0, Day 90, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bone health parametersTimepoint: Day 0, Day 90, Day 180;Change in inflammatory risk factorsTimepoint: Day 0, Day 90, Day 180;Change in metabolic risk factorsTimepoint: Day 0, Day 90, Day 180;Change in the quality of life scoresTimepoint: Day 0, Day 90, Day 180 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed