CTRI/2023/05/053143尚未招募2 期
PREVALENCE OF RASADHATU DUSHTI IN PARTICIPANTS AT RISK OF CARDIOVASCULAR DISEASE AND COMPARATIVE EFFECT OF PANCHKOL CHURNA AGAINST LIFE-STYLE MODIFICATION AS A RISK REDUCTION MEASURE: AN OBSERVATIONAL AND EXPLORATORY CLINICAL STUDY
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Stage :1 Inclusion Criteria:
- •1.Subjects of either gender in the age group of 30-60 years (both years inclusive).
- •2.Subjects fulfilling any one of the following criteria for abnormal lipid profile:
- •a)Subjects with Total cholesterol level ( >200mg/dl).
- •b)Subjects with Triglyceride level ( >150mg/dl).
- •c)Subjects with HDL level ( < 40mg/dl).
- •d)Subjects with LDL level ( >140mg/dl).
- •3.Subjects willing to participate and provide informed written consent
- •4.Participants fulfilling any three of the following criteria will be selected to participate in the survey:
- •i.Overweight/Class-1 obese (body mass index [BMI]: 25â??35 kg/m2), Subjects with low BMI but abnormal lipid profile, or subjects with both or at least any of the above diagnostic criteria will be selected for the study.
- •ii.Subjects having a family history of cardiovascular events like myocardial infarction, stroke, or peripheral vascular occlusive diseases.
- •iii.Subjects with history of tobacco smoking.
- •iv.Subjects with documented history of hypertension.
- •v.Subjects with documented history of diabetes mellitus.
- •5.Subjects with RAS-RCVD Score >=10.
- •6.Subject willing to participate and ready to give informed consent.
- •1.Subjects at risk of CVDs diagnosed from observational study.
- •2.Subjects with RAS-RCVD Score >=10.
- •3.Subject willing to participate and ready to give informed consent.
排除标准
- •Stage 1: Exclusion Criteria:
- •1.Subjects having history of cardiovascular events like myocardial infarction, stroke, or peripheral vascular occlusive diseases.
- •2.Subjects with documented history of hypertension.
- •3.Subjects with documented history of diabetes mellitus.
- •4.Patient with history of clinically-active hepatic or peptic ulcer disease.
- •5.Subjects planning to undergo surgery in next 3 months will be excluded from the study.
- •6.Subjects who are pregnant, breast feeding or planning to become pregnant during the study.
- •7.Subjects participated in any other clinical trials within thirty (30) days prior to screening.
- •8.Patient with history of severe allergy or anaphylactic reaction.
- •9.Any other condition which the investigator think may jeopardize the participant condition.
- •Stage 2: Exclusion Criteria:
- •1.Subjects having history of cardiovascular events like myocardial infarction, stroke, or peripheral vascular occlusive diseases.
- •2.Subjects with documented history of hypertension.
- •3.Subjects with documented history of diabetes mellitus.
- •4.Patient with history of clinically-active hepatic or peptic ulcer disease.
- •5.Subjects planning to undergo surgery in next 3 months will be excluded from the study.
研究者
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