跳至主要内容
临床试验/CTRI/2024/06/069396
CTRI/2024/06/069396尚未招募2 期

An Open Clinical trial to evaluate the therapeutic efficacy of selective Siddha medicine in the management of Hyperlipidemia among outpatients attending Ayothidoss Pandithar Hospital, National Institute Of Siddha

National Institute Of Siddha1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月2日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Reduction in values of lipid profile will be assessed before and after treatment.

研究概览

简要总结

BACKGROUND:

Siddha system is one of the ancient systems of medicine in the world. It is mainly based on three vital humours named Vali, Azhal and Iyam. The inimitable of this system is efficacy of drugs with various adjuvant evidenced for assortment of diseases. Siddha system not only deals with diseases, treatment, prevention, cure and also lifestyle.

HYPERLIPIDEMIA is one of the life style modification diseases in our country. Hyperlipidemia which is increased levels of lipids. Hyperlipidemia includes both hypercholestremia and hypertriglyceridemia. Although it does not show any symptoms, it lay concrete for many diseases –cardiovascular diseases and stroke are very common due to atherosclerosis. Hyperlipidemia is one of the major risk factor for coronary heart disease (CHD) a major leading cause of mortality in developed countries, will soon become the pre-eminent health problem worldwide.

Recent epidemiological studies reveals that there is an increase in lipid levels globally. There is wide variation in the prevalence, awareness, and treatment of hyperlipidemia between populations. According to WHO MONICA PROJECT the prevalence of hypercholestremia varied across populations from 3% to 53% in men, and from 4% to 40% in women. Awareness of hypercholestremia varied from 1% to 33% in in men, and from 0% to 31% in women. In most populations, over 50% of men and women on lipid lowering drugs.

The World Health Organization (WHO) reports that high cholesterol contributes to 56% of cases of coronary heart disease worldwide and causes more than 4 million deaths each year. In most parts of the world, the number of female deaths attributed to high cholesterol is slightly higher than the number of male deaths.

India is a developing country has been showing an increase in the incidence of hyperlipidemia, for the past few decades. In young adult Indian population the prevalence dyslipidemia was observed to be higher in males than in females. Among particicipants who had a total cholesterol (TC) concentration 200mg/dl, 38.7% were males and 23.3% were females. High density lipoprotein (HDL-C) was abnormally low in 64.2% males and 33.8% in females. The increase of prevalence of hypercholestremia and hypertriglyceridemia was more prominent in 31-40 age group than in 30 age group.

Another epidemiological study in South India conducted by Sri Ramachandra University, Chennai, mentioned that the prevalence of abnormal serum lipid levels was more prominent in the age group of 40-59 years in both sexes. High levels of triglycerides were identified in 41.5% and very high levels in 1.2%. LDL –cholesterol levels were high in 32.9% and very high in 7.45%, and a higher total cholesterol were found in 25.35%. HDL-cholesterol levels were found to be low in 34.35%.

It is the right time for the measures to be taken for this disease. Many Siddha medicines have been indicated for increased level of lipids. Several indigenous plants have been claimed to possess hypolipidemic and hypocholesteremic properties that may be beneficial to reduce the risk of cardiovascular diseases.

OBJECTIVE:

To evaluate the therapeutic effectiveness of siddha formulation “KARUNJEERAGA CHOORANAM, SILASATHU PARPA MATHIRAI” in the management of HYPERLIPIDEMIA by improvement in lipid profile among out patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.

STUDY DESIGN : An Open Clinical Trial

STUDY PLACE : Maruthuvam department OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium

Chennai-47

STUDY PERIOD : 6 months

SAMPLE SIZE : 20 patients

INCLUSION CRITERIA:

 Age group: 20-60 years

 All Gender

 Increased levels of any one of the lipid profile according to WHO guidelines.

 Patient who was already diagnosed as hyperlipidemia.

 Patient who are willing to provide blood for investigations before and after treatment.

EXCLUSION CRITERIA:

ï‚§ Patients with chronic kidney diseases, cardiovascular diseases

ï‚§ Active vascular disease (e.g. unstable angina, stroke like symptoms)

ï‚§ Patients with known liver diseases.

ï‚§ Pregnancy and lactation

ï‚§ Patients with any other serious illness.

OUTCOME OF TREATMENT:

Reduction in values of lipid profile will be assessed before and after treatment.

RESULTS AND DISCUSSION: The results will be statistically analysed and reported.

KEYWORDS: Hyperlipidemia, Karunjeeraga chooranam, Silasathu parpa mathirai

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 1.Increased levels of any one of the lipid profile according to WHO guidelines.
  • 2.Patient who was already diagnosed as hyperlipidemia.

排除标准

  • 1.Patients with chronic kidney diseases, cardiovascular diseases 2.Active vascular disease (e.g. unstable angina, stroke like symptoms) 3.Patients with known liver diseases.
  • 4.Pregnancy and lactation ï‚§ Patients with any other serious illness.

结局指标

主要结局

Reduction in values of lipid profile will be assessed before and after treatment.

时间窗: Reduction in values of lipid profile will be assessed after the period of 48 days.

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Megha S

National Institute of Siddha

研究点 (1)

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