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临床试验/CTRI/2020/06/025899
CTRI/2020/06/025899尚未招募1 期

COMPARATIVE EVALUATION OF THE EFFICACY OF MEDOHAR VATI IN DYSLIPIDEMIA (MEDOROGA)

Patanjali Research Institute Haridwar0 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
1 期
状态
尚未招募
发起方

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

  • Participant is not on a statin or other lipid-modifying therapy.
  • Plasma levels >=200 mg/dL for TC, >=130 mg/dL for LDL-C, <40 mg/dL for HDL-C, and >=150 mg/dL and (b) serum CRP >5 mg/dL.

排除标准

  • oFemale participant of reproductive potential.
  • oParticipant is pregnant, breastfeeding, or expecting to conceive during the study.
  • oParticipant has history of cancer within 5 years of study (except certain types of skin and cervical cancer).
  • oParticipant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse.
  • oParticipant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study.
  • oParticipant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week.
  • oParticipant is currently experiencing menopausal hot flashes.
  • oParticipant currently engages in vigorous exercise or an aggressive diet regimen.
  • oParticipant is at high risk for heart conditions.
  • oParticipant has Type 1 or Type 2 diabetes mellitus.
  • oParticipant has poorly controlled cardiac arrhythmias.
  • oParticipant has a history of stroke or other hemorrhage.
  • oParticipant has poorly controlled high blood pressure.
  • oParticipant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids.
  • oParticipant has a disease of the kidney or liver.
  • oParticipant has an ulcer within 3 months of screening.
  • oParticipant is Human Immunodeficiency Virus (HIV) positive.
  • oParticipant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy.
  • oParticipant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening.
  • oParticipant has taken an anti-obesity medication within 3 months of screening.
  • oParticipant is taking coumarin.
  • oParticipant is taking Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed).
  • oParticipant is taking more than 100 mg aspirin per day.
  • oParticipant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents.

研究者

发起方
Patanjali Research Institute Haridwar

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