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临床试验/CTRI/2023/05/053143
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

All India Institute of Ayurveda0 个研究点目标入组 0 人开始时间: 待定最近更新:

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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