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临床试验/CTRI/2013/09/003952
CTRI/2013/09/003952尚未招募1/2 期

A comparative clinical study of Tryoshnadi Guggulu and Lasuna in management of dyslipidemia

Institute for Post Gradute Teaching and Research of Ayurved Gujarat Ayurved Universuty jamnagar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年5月10日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Assessment will be made mainly based on the improvement observed in the subjective and objective parameters before treatment and after treatment. The prakriti, agnibala, roga bala and rogi bala will also be taken into consideration

研究概览

简要总结

Dyslipidemia is elevation of plasma cholesterol, triglycerides (TGs), or both, or a low high-density lipoprotein level that contributes to the development of atherosclerosis. Causes may be primary (genetic) or secondary. Diagnosis is by measuring plasma levels of total cholesterol, TGs, and individual lipoproteins. Treatment is dietary changes, exercise, and lipid-lowering drugs.

There is no natural cutoff between normal and abnormal lipid levels because lipid measurements are continuous. A linear relation probably exists between lipid levels and cardiovascular risk, so many people with “normal†cholesterol levels benefit from achieving still lower levels. Consequently, there are no numeric definitions of dyslipidemia; the term is applied to lipid levels for which treatment has proven beneficial. Proof of benefit is strongest for lowering elevated low-density lipoprotein (LDL) levels. In the overall population, evidence is less strong for a benefit from lowering elevated TG and increasing low high-density lipoprotein (HDL) levels, in part because elevated TG and low HDL levels are more predictive of cardiovascular risk in women than in men.

HDL levels do not always predict cardiovascular risk. For example, high HDL levels caused by some genetic disorders may not protect against cardiovascular disorders, and low HDL levels caused by some genetic disorders may not increase the risk of cardiovascular disorders. Although HDL levels predict cardiovascular risk in the overall population, the increased risk may be caused by other factors, such as accompanying lipid and metabolic abnormalities, rather than the HDL level itself.

By seeing all conditions, we cannot find one to one co-relation with a single disease from Ayurveda classics, though condition is suggestive of pathologies like Rasagata Ama, Raktagata Ama, Sthaulya, Medoroga, Medodosha etc. By considering all the situations it can be assumed that of pathology is related to Kapha Karaka Nidana i.e.- Santarpana Ahara Vihara,which includes sedentary life style, high calories food intake, lack of exercise which finally leads to morbidity of Kapha Dosha and Medo Dhatu. Due to Medodhatwagni Dusti excessive accumulation of abnormal Kapha  and Medo  occurs in various Strotas in body. Aparipakva Kapha – Meda present in Rasa-Raktavaha Strotasa results in obstruction to the movement of Vata & Rakta through affected channel finally ends up in disease manifestation according to the site of affliction. The state of Apakva Kapha or Meda and its excessive presence Margavarana in Rasa-Raktavaha Strotasa is often compared with the state of dyslipidemia.

Hence, a formulation named Tryoshnadiguggulu containing Ushna,Tikshna, Katu and Shrotoshodhaka action was selected for patients of dyslipidemia, it may help to break the Samprapti or Clear the Ama, Kapha,and Meda and hence may help to manage the dyslipidemia.

Keeping in mind above facts, it may be said thatThe final purpose of management is to stop the formation of Apakva Kapha and Meda and to clear the avarana and then re-establishing the normal movement of vata.

Recent work on Lasuna has showed lipid/cholesterol lowering effect  and hence was also selected to establish its role in the management of dyslipidemia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • Patients having age between 25 – 60 years of either sex S.
  • Cholesterol > 200 mg/dlor/and S.
  • Triglyceride > 150 mg/dl or/and S.L.D.L >130 mg/dl or/and S.V.L.D.L>40 mg/dl or/and S.H.D.L <40 mg/dl.

排除标准

  • •Age below 25 and above 60 years •Patients suffering from type 1 Diabetes mellitus and uncontrolled diabetes mellitus & uncontrolled hypertension •Drug induced & uncontrolled dyslipidemia •Systemic illness like Tuberculosis, Carcinoma and Endocrine disorders •Patient having the past history of M.I. & Unstable Angina.
  • •Patient having Clinical Features of CCF •Patient Having the major renal or liver disorder •Normal range of Apolipoprotien B is 40-125 mg/dl, if it increased with severity of symptoms, patients will be excluded.

结局指标

主要结局

Assessment will be made mainly based on the improvement observed in the subjective and objective parameters before treatment and after treatment. The prakriti, agnibala, roga bala and rogi bala will also be taken into consideration

时间窗: Assessment will be made mainly based on the improvement observed in the subjective and objective parameters before treatment and after treatment. The prakriti, agnibala, roga bala and rogi bala will also be taken into consideration

次要结局

  • assessment will be done by only symptoms.(2 weeks)

研究者

发起方
Institute for Post Gradute Teaching and Research of Ayurved Gujarat Ayurved Universuty jamnagar
申办方类型
Research institution and hospital

研究点 (1)

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