CTRI/2025/10/096023尚未招募Unknown
A Prospective, Randomized, Open Label Study to Evaluate the Efficacy and Safety of CitraFit™ in Reducing Cardiovascular Risk Factors
Ziran India1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月27日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- "Change in Serum TG levels from baseline to end of treatment
研究概览
简要总结
| This is |
| a prospective, randomized, open label clinical study designed to evaluate the |
| efficacy and safety of CitraFit™ in adults with cardiovascular risk factors. |
| A total of 80 subjects will be enrolled and randomized into three groups: |
| placebo/standard of care (20), standard of care + CitraFit™ (30), and |
| CitraFit™ alone (30). The treatment duration will be 90 days, with a total |
| study duration of 8 months. The primary outcomes include changes in serum |
| triglycerides, total cholesterol, LDL cholesterol, and systolic blood |
| pressure. Secondary outcomes will assess safety and tolerability. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who voluntarily participate in this study by signing their Informed Consent Form (ICF) in the local language prior to any study-mandated procedure Males or females aged 35 to 65 years at the time of signing the ICF Subjects diagnosed with increased Cardiovascular Risk Factors, evidenced by laboratory investigations conducted within 6 months prior to the screening visit and confirmed again during the screening visit.
- •The criteria include Total Cholesterol more than 1.5 times ULN Triglycerides more than 1.5 times ULN High-Density Lipoprotein more than 40 mg per dL Low-Density Lipoprotein more than 130 mg per dL Subjects who are on statins should be on a stable dose at least for 3 months prior to the screening visit for Arm 1 and Arm 2 Subjects who are newly diagnosed (treatment-naive) are taken for Arm
- •Type 2 diabetes subjects stable on treatment for last 2 months.
- •Subjects ready to discontinue the use of supplementations including vitamins glucosamine chondroitin herbals or any other ongoing nutritional supplements Willing to comply with all the study-related activities.
排除标准
- •Currently participating in another investigational study Female subjects who are pregnant or lactating.
- •History of severe allergies to Citrus Bioflavonoids or similar supplements.
- •Concomitant use of medications known to interact with herbal remedies.
- •Severe psychiatric disorders.
- •Subjects with a planned or anticipated surgery during the study period.
- •Subject history of any respiratory or breathing disorders.
- •Subjects with HIV Positive status.
- •Alcohol intake more than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers.
- •Clinically significant or abnormal laboratory results other than those relevant to the study indication during screening.
- •Diagnosis of Type 1 diabetes, recent surgery, liver diseases, jaundice, kidney issues, use of antidepressants, sleep disorders, psoriasis, and inflammatory diseases like rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, asthma, chronic obstructive pulmonary disease (COPD) and any other inflammatory diseases which in the opinion of the Principal Investigator (PI) may impact the outcome of the study.
结局指标
主要结局
"Change in Serum TG levels from baseline to end of treatment
时间窗: Day 0 and 90
Change in TC levels from baseline to end of treatment
时间窗: Day 0 and 90
Change in LDL Levels from baseline to end of treatment
时间窗: Day 0 and 90
Change in HDL levels from baseline to end of treatment
时间窗: Day 0 and 90
Change in Serum NO levels from baseline to end of treatment
时间窗: Day 0 and 90
Change in SBP from baseline to end of treatment"
时间窗: Day 0 and 90
次要结局
- Safety and Tolerability Monitoring adverse events (and overall tolerability of CitraFit(Improvements in Risk Factor Control Stability of lipid profiles blood pressure and cardiovascular health)
研究者
Dr Poojari Haribabu
Government Medical College & Govt General Hospital Old RIMSGGH
研究点 (1)
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