Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified Health Condition 2: E663- Overweight
Conditions
Interventions
Intervention1: Saunfbhara: Saunfbhara (Current studied product) is a polyherbal liquid/Capsule like preparation will be given 1-2 capsule twice daily orally for 12 weeks
Control Intervention1: Guggulu
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Subjects of either sex (Male and Female) in the age group of 18 to 65 years, both inclusive. •Subjects with LDL-C greater or equal than 130 at the time of screening. •Subjects with BMI greater or equal than 25 •Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
Exclusion criteria
Exclusion criteria: •Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II •Subjects who have Diet with excess cholesterol, saturated fat or calories •Subjects with uncontrolled Hypothyroidism or Hyperthyroidism •Known cases of Severe/Chronic Hepatic or Renal disease •Known subject of any active malignancy. •Subjects giving history of significant cardiovascular event •Known case of Anorexia Nervosa or Bulimia nervosa •Chronic alcoholics / Alcohol Abuse •Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia. •Subjects X- ray chest showing any active lesion of tuberculosis •Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV. •Subjects using any other investigational drug within 1 month prior to recruitment •Known hypersensitivity to any of the ingredients used in study drug •Pregnant and Lactating females. •Subjects currently participating in any other Clinical study •Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in LDL-C level at the end of study (12 weeks) 2. Change in body weight at the end of study (12 weeks) Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in LDL-C level at 6 weeks,Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC), High Density Lipoprotein (HDL), Body Weight, BMI, Waist circumference, Waist to hip ratio and EQ-5D Quality of Life (QOL) at 6 weeks and 12 weeks, Overall efficacy and safety of the study product as per the physician (CGI-I) at the end of study (12 weeks),Safety assessment by assessing adverse drug reactions, clinically significant abnormal laboratories valuesTimepoint: 6 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Dabur India Limited
Outcome results
None listed