The Purpose of the study is to evaluate the efficacy of herbal composition CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects.
A total of 150 male and female subjects aged between 25 and 55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL19183:450 mg or CL24212:300 mg or Placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 16 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL19183 and CL24212 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
150
Swaroop Rani Hospital, Motilal Nehru Medical College
Allahābād, Uttar Pradesh, India
Change from baseline to the end of the study period in Body weight
The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.
Time frame: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16
Change from baseline to the end of the study period in Body mass index (BMI)
Body mass index is a calculated measure by considering the weight and height of a subject. A change in BMI from overweight to normal range is a positive indicator of healthy lifestyle.
Time frame: Screening, Week 0 (Baseline),Week 2, Week 4, Week 8, Week 12 & Week 16
Change from baseline to the end of the study period in Body composition using DEXA (including fat and lean mass)
A low-dose X-ray is used to assess the fat and lean mass of a subject. An increase in lean mass indicates significant improvement, while a reduction in fat mass contributes to better overall health in the subject
Time frame: Week 0 (Baseline), Week 8& Week 16
Change from baseline to the end of the study period in Waist (WC)
Waist circumference is measured around the abdomen, just above the navel. This value is influenced by the subject's height and weight. A reduction in waist circumference indicates improvement in body weight, as well as decreased fat storage and deposition.
Time frame: Week 0 (Baseline),Week 2, Week 4,Week 8,Week 12,Week 16
Change from baseline to the end of the study period in Hip circumference (HC)
It represents the maximum circumference measured around the buttocks. This measurement is influenced by the subject's height and weight. A reduction in this value indicates improvements in body weight, as well as a decrease in fat storage and deposition
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Time frame: Week 0 (Baseline),Week 2, Week 4,Week 8,Week 12,Week 16
Change from baseline to the end of the study period in Waist to hip ratio (WHR)
It's a ratio of waist to hip circumference. As the waist-to-hip ratio changes to the normal range according to person's demographic profile, this is associated with improvements in metabolism and body weight
Time frame: Week 0(Baseline), Week 2, Week 4, Week 8, Week 12& Week 16
Change from baseline to the end of the study period in Lipid profile (including amyloid A)
Amyloid A (AA) is derived from serum amyloid A (SAA), an acute-phase reactant produced predominantly by the liver during inflammation, including obesity, which can lead to elevated levels of serum amyloid A (SAA). In AA amyloidosis, amyloid deposits typically affect the kidneys (leading to proteinuria and renal impairment.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in Lipid profile (including Apo B)
Apo B is a protein found on the surface of therogenic lipoproteins, including VLDL, IDL, LDL, and lipoprotein(a). It reflects the number of potentially harmful lipoprotein particles, making it a strong marker for cardiovascular risk due to obesity.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in Adiponectin
Adiponectin is a hormone secreted primarily by adipose (fat) tissue. It plays a crucial role in regulating glucose levels and fatty acid breakdown, contributing to metabolic health. Higher levels of adiponectin are associated with increased insulin sensitivity, anti-inflammatory effects, and reduced risk of cardiovascular disease
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in Ghrelin
Ghrelin is a hormone primarily produced in the stomach, with smaller amounts secreted by other tissues such as the small intestine, pancreas, and brain. It is often referred to as the "hunger hormone" because it plays a key role in regulating appetite and energy balance. Abnormal ghrelin levels have been associated with conditions like obesity.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in total glucagon-like peptide 1(GLP- 1)
Glucagon-like peptide-1 (GLP-1) is an incretin hormone primarily produced in the intestinal L-cells in response to nutrient ingestion. It plays a significant role in glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, slowing gastric emptying. GLP-1 influences weight management primarily by suppressing appetite, slowing gastric emptying, and reducing food intake.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in C-Peptide
C-peptide is a short chain of amino acids that is released into the bloodstream as a by-product when insulin is produced by the pancreas. During obesity, C-peptide levels are typically elevated due to increased insulin secretion driven by insulin resistance. Monitoring these levels can help assess β-cell function and the risk of progression to diabetes.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in Glucagon
Glucagon is a hormone produced by the alpha cells of the pancreas that primarily functions to increase blood glucose levels by stimulating hepatic glucose production. During weight loss, increased glucagon levels may be beneficial because It promotes the mobilization of stored fat by encouraging lipolysis.it helps maintain blood glucose levels when carbohydrate intake is reduced.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in VCAM-1
VACM-1 is a cell surface glycoprotein expressed primarily on vascular endothelial cells in response to inflammatory stimuli. It plays a crucial role in mediating the adhesion and transmigration of leukocytes during inflammatory processes. In obesity, due to chronic low-grade inflammation, pro inflammatory cytokines such as IL-6, TNF-a induce the up regulation of adhesion molecules like VCAM-1 on endothelial cells lining blood vessels in adipose tissue.
Time frame: Week 0 (Baseline), Week 8 & Week 16
Change from baseline to the end of the study period in ICAM- 1
Day 1 (Baseline), Week 8 \& Week 16
Time frame: ICAM-1 is typically expressed at low levels on various cell types, including endothelial cells (lining blood vessels), immune cells (like leukocytes), and epithelial cells. ICAM-1 expression is significantly upregulated in adipose tissue in obesity.