跳至主要内容
临床试验/CTRI/2020/01/022906
CTRI/2020/01/022906尚未招募不适用

AN OPEN-LABELLED RANDOMIZED CONTROLLED PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY OF GUDUCHYADI CHURNA IN THE MANAGEMENT OF MEDOROGA W.S.R DYSLIPIDEMIA

Dr Parvathy B1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Reduction in the levels of Total cholesterol, LDL, VLDL, Triglycerides.

研究概览

简要总结

This study is put forward to evaluate the efficacy of Guduchyadi churna on the samprapti of medoroga w.s.r dyslipidemia in comparison to Navaka guggulu.

Hypothesis:

Null hypothesis-H0: The efficacy of Guduchyadi churna is equivalent to the efficacy of Navaka guggulu in the management of medoroga w.s.r dyslipidemia.

Research hypothesis-H1: The efficacy of Guduchyadi churna is not equivalent to the efficacy of Navaka guggulu in the management of medoroga w.s.r dyslipidemia.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with increased level of any of the serum lipids, such as serum cholesterol(200-350mg/dl), serum triglycerides (150- 400mg/dl), serum low density lipoproteins (LDL) (130-250mg/dl), serum very low-density lipoprotein (40-150mg/dl), diagnosed cases and fresh cases will be included.
  • Patients taking Lipid lowering medications will be included for the study after a wash out period of 15 days after the stoppage of medicines.
  • Both obese and non-obese patients will be included.
  • Subjects willing to give informed consent.

排除标准

  • Patients with uncontrolled major systemic disorders, patients with HbA1c above 8 % (HPLC method) or above 9% (IEC method), patients with TSH levels above 5.0 mU/L, pregnant & lactating women.

结局指标

主要结局

Reduction in the levels of Total cholesterol, LDL, VLDL, Triglycerides.

时间窗: 30th day, 60th day

次要结局

  • Reduction in the classical lakshanas of Medoroga(30th day, 60th day)

研究者

发起方
Dr Parvathy B
申办方类型
Other []

研究点 (1)

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