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临床试验/CTRI/2024/09/074046
CTRI/2024/09/074046尚未招募3 期

Efficacy of Talapatra Kshara in Medoroga W.S.R to Dyslipidemia- A Randomized Controlled Clinical Trial

Dr Subhrajyoti Moharana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Lipid profile including

研究概览

简要总结

The rapid rise of non-communicable diseases represents one of the major challenges to global development in the new century. Each year more than 15 million people die from NCD; 85% of these ‘premature’ deaths occur in low- and middle-income countries. According to WHO’s projections, the total annual number of deaths from NCDs will increase to 55 million by 2030. Global economic and social development is threatened by this emerging challenge.

Dyslipidemia is an extremely important condition, principally because of its contribution to atherogenesis and it is an independent and modifiable risk factor for CAD. The incidence of dyslipidemia is increasing in many developed and developing countries mainly due to the westernization of diet and sedentary lifestyles.

According to the ICMR–INDIAB Study, over three-fourths (79%) of the general adult population covered in the survey have abnormalities in at least one of the lipid parameters with no urban-rural difference. Even the youngest age group has high rates of dyslipidemia.  The prevalence of dyslipidemia [as defined by National Cholesterol Education Program (NCEP) guidelines] in Indians is very high, with 79% of subjects having at least dyslipidemia, 72.3% subjects had high cholesterol in the high-density lipoprotein (HDL-C) level, 29.5% of subjects had hypertriglyceridemia and 11.8% of subjects had elevated low-density lipoprotein cholesterol (LDL-C). Therefore, optimal management of dyslipidemia along with management of other risk factors is essential to prevent the AS, and CVD pandemic

Statins are the first choice in the treatment of dyslipidemia. The data from the US National Health and Nutrition Examination Survey conducted from 1999 to 2000 reported that 25% of adults either had total cholesterol >239.4 mg/dl or were taking a lipid-lowering medication. Lifestyle modifications should always be a part of the management of dyslipidemia. However, the need for long-term, lifelong therapy is associated with several adverse effects such as myopathy, increased risk of renal failure, hypothyroidism, and memory loss in 15%-20% of the patients on treatment with statins.

 â€œKsharas” are known for their lekhana, karshana, kaphahara, and medohara actions. According to Sushruta, it is Naati Tikshna, Naati mrudu, Shighra Prabhavakai. Since Talapatra is widely accessible and used for conditions like Medoroga, Mutrakrichra, Mutraghata, swasa the study is intended to prepare talapatra kshara. TalaPatra Kshara has received little attention from researchers in recent years, but it’s theoretical underpinnings and historical applications make it a promising candidate for Medoroga.

Based on the above facts, to get a way through the burning issues of Medoroga, the present study has been planned.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Subjects between the age group of
  • 50 years irrespective of gender, religion, occupation, and socioeconomic status. Abnormal serum lipid levels like serum cholesterol (201 mg/dl or more), serum TGLs (161 mg/dl or more), serum HDL (below 40 mg/dl), serum LDL (131 mg/dl or more), and serum VLDL (41 mg/dl or more) Having clinical features of Medoroga.

排除标准

  • Subjects below 20 years and above 50 years of age.
  • Patient with a history or evidence of systemic disorders like Cardiac, renal & neurological diseases.
  • Diseases including Diabetes mellitus, Liver cirrhosis, Hypertension & other malignancy.
  • Pregnant and lactating women.

结局指标

主要结局

Lipid profile including

时间窗: Baseline, Day 15, day 31

a) Serum Cholesterol

时间窗: Baseline, Day 15, day 31

b) Serum Triglycerides

时间窗: Baseline, Day 15, day 31

c) Serum HDL

时间窗: Baseline, Day 15, day 31

d) Serum LDL

时间窗: Baseline, Day 15, day 31

e) Serum VLDL

时间窗: Baseline, Day 15, day 31

次要结局

  • Subjective Parameters(a) Difficulty in doing routine work (Sarva karmasu Ashaktata))

研究者

发起方
Dr Subhrajyoti Moharana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Subhrajyoti Moharana

KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

研究点 (1)

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