A prospective, multicenter, open label, active controlled, randomized clinical trial to evaluate efficacy and safety of Vestige Flax Oil capsules in patients suffering from Dyslipidemia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- •Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study.
研究概览
简要总结
Primary objective of this study was to evaluate the efficacyof Vestige Flax Oil Capsule in patient suffering from dyslipidemia by the meanchange value of LDL-C (Low DensityLipoprotein Concentration) from baseline (visit 1) to visit 2.
Subjects were randomized into two arms. i.e., group 1 (Vestiage flax oiland SOC) and group 2 (SOC)
Group A (Flax Oil Capsules withstandard of care) showed significant alleviation in the mean value oflow-density Lipoprotein concentration (LDL-C) i.e., 79.04 (on visit 2) from177.68 (on baseline -visit 1).
Group B (Standard of care alone): alsoshowed significant alleviation in the mean value of low-density Lipoproteinconcentration (LDL-C) i.e., 80.64 (on visit 2) from 168.56 (on baseline -visit1).
Secondary objective of this study was to evaluate the safety &tolerability of Vestige Flax Oil Capsules for treatment in patients sufferingfrom Dyslipidemia by evaluating follwoing parameters:
· Mean Change in Total Cholesterol Concentrationfrom baseline toend of the study.
· Mean change in High-Density Lipoprotein (HDL-C) from baseline to end of thestudy
· Mean change in Triglyceride concentration (TG) from baseline to end of thestudy.
· Safety and tolerability of the study drug(s) will be assessed by theClinical AEs occurring during entire duration of study.
Group A (Flax Oil Capsules withstandard of care) showed significant alleviation in the mean value of totalcholesterol concentration i.e., from 273.12 on baseline (visit 1) to 159.16 onvisit 2.
Group B (Standard of care alone): also showedsignificant alleviation in the mean value of total cholesterol concentrationi.e., from 264.84 on baseline (visit 1) to 157.64 on visit 2.
Group A (Flax Oil Capsules withstandard of care) does not reflect any significant fluctuation in the mean valueof High-DensityLipoprotein (HDL-C)i.e., from 50.16 on baseline (visit 1) to 49.12 on visit 2.
Group B (Standard of care alone): alsoshowed a little fluctuation in the mean value of High-Density Lipoprotein(HDL-C) i.e., from 53.72 onbaseline (visit 1) to 47.84 on visit 2.
Group A (Flax Oil Capsules withstandard of care) showed significant alleviation in the Triglycerideconcentration (TG) i.e.,from 223.68 on baseline (visit 1) to 155.04 on visit 2.
Group B (Standard of care alone): alsoshowed significant alleviation in the Triglyceride concentration (TG) i.e., from 213.24 on baseline(visit 1) to 163.4 on visit 2.
There was one adverseevent reported in Group B (SOC Arm) of the study which was not related to thestudy drug.
Overall conclusions:
From current data set analysis of this proof-of-concept study it can beconcluded that Vestige Flax oil Capsule has shown promising results inimproving Dyslipidemia when used along with Standard of care. Study met itsprimary and secondary endpoints with significant results. Vestige Flax oilCapsule are also safe to be used as the study documented only 1 adverse eventin Group B (SOC arm) which was not related to study drug or any study relatedprocedures. However, double blind, placebo-controlled studies with largersample size, quality of life anlysis and increased duration of consumption canbe conducted to reproduce results like current study in consideration. Itsimpact on various haematological and other parameters can also be evaluated infuture studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Subject is willing and able to give written informed consent.
- •2.Female subjects aged ≥ 18 and ≤ 65 years 3.The subjects will be considered to have dyslipidemia if they met 2 of the following 4 criteria: •fasting total cholesterol concentration>200 mg/dL, •fasting triglyceride concentration>150mg/dL, •fasting LDL-cholesterol concentrations>100 mg/dL, or •fasting HDL-cholesterol concentrations>40 mg/dL.
- •4.Patients who are taking lipid lowering drugs should continue the same dosage during the study.
- •5.Subject is willing, able, and likely to comply with all study procedures and restrictions.
排除标准
- •1.Subjects with history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.
- •2.Subjects who have used any antioxidant such as Vitamin E, vitamin C, Phytochemicals, and coenzyme Q10 within two months before trial.
- •3.Pregnant or lactating women 4.Patients with Homozygous Familial Hypercholesterolemia 5.AST or ALT level increases at least twice the upper limits of normal in patients 6.Subjects who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial.
- •7.Any other condition that in the investigator’s judgment might interfere with study objectives.
结局指标
主要结局
•Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study.
时间窗: Day 0 to Day 56
次要结局
- •Mean change in Total Cholesterol Concentration from baseline to end of the study.(•Mean change in High-Density Lipoprotein (HDL-C) from baseline to end of the study.)