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A clinical study to assess the potential effect and safety of SUN-CA on the Risk Factors of Obesity

A Prospective, Randomized, Double blind, Parallel group, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of SUN-CA on the Risk Factors of Obesity - SUN-CA

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008170
Enrollment
70
Registered
2017-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Overweight or obese individuals with a BMI between 25-30 in the age group of 18-60 years

Interventions

Intervention1: SUN-CA: Sunflower extract Control Intervention1: Placebo: Maltodextrin

Sponsors

Vidya Herbs Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are willing to give written informed consent. 2. Patient is willing and able to comply with all trial requirements 3.Overweight or obese; BMI between 25-30

Exclusion criteria

Exclusion criteria: • Subjects with BMI >30 • Cigarette smoker, History of heart, liver and kidney disease, hypertension, pregnancy, lactating, Type 1 diabetes and weight loss medication.

Design outcomes

Primary

MeasureTime frame
1. Reduction in body weight and BMI at week 4, 8 and 12 of treatment 2. Muscle mass fat mass ratio, body fat (%) Timepoint: 1. Reduction in body weight and BMI at week 4, 8 and 12 of treatment 2. Muscle mass fat mass ratio, body fat (%) at Day 1 and week 12

Secondary

MeasureTime frame
1. Changes in lipid profile (Triglycerides, cholesterol, HDL and LDL) 2. Blood pressure 3. Changes in anthropometric measurements â?? Waist and hip circumference; Waist-hip ratio 4. Quality of life of subjects before and after treatment 5. Incidence and rate of adverse events Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Byresh A

Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre

byresh23@gmail.com9886414563

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026