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临床试验/CTRI/2022/07/043957
CTRI/2022/07/043957尚未招募不适用

A Synopsis On Effectiveness Of Individualized Homoeopathic Medicines And Glycyrrhiza Glabra Mother Tincture In The Treatment Of Hyperlipidemia: An Open Randomized Clinical Trial

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
It will be done using Serum lipid profile according to NCEP desirable cholesterol level as:

研究概览

简要总结

Hyperlipidemia is considered as one of the major risk factors causing cardiovascular diseases (CVDs). It is commonly seen in above the age of 25 years. Researches showed that overall, 33.8% of the population presented any of the forms of hyperlipidemia, being more frequent in men (50.6%) than in women (28.8%). It causes Tuberous xanthomas in the Achilles tendon, hands, feet, elbows, and/or knees and Corneal arcus of the eye, Dyspnea, Paresthesia and Confusion. It does not have symptoms at all, but it can cause other symptomatic vascular disease, like coronary artery disease. Proper case taking is done and patients will be divided into two parallel arms. 50% patients will receive individualized homoeopathic medicines and 50% will receive Glycyrrhiza glabra mother tincture. Each enrolled case will be followed up monthly, Serum lipid profile will be done at the baseline, 3rd month, and at 6thmonth to assess/compare the change in serum lipid level. The assessment of the outcome of the treatment will be done using COOP/WONCA Functional Assessment chart gradation at the baseline, 3rd month, and at 6th month in particular level.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • a) Patients of both sexes and all religions.
  • b)Patients with Body Mass Index (BMI): For females 25–30 and For males 26–
  • c) Patients already undergoing to regular therapy for hyperlipidemia, provided the medication are stopped completely at least 2 weeks prior study entry.
  • d) Patients giving written consent to participate in the study.

排除标准

  • a) Patients of age group below 30 and above 70 years.
  • b) Patients with BMI: Females, BMI < 19, Males, BMI < 20 c) Patients who will be too sick for consultation.
  • d) Patients of diagnosed cases of systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting quality of life or any organ failure, pregnancy and lactation, substance abuse and/or dependence, self reported immunocompromised state, and patients availing homeopathic treatment for chronic disease within last 6 months.
  • e) Patients unwilling to take part or not giving consent to participate in the study.

结局指标

主要结局

It will be done using Serum lipid profile according to NCEP desirable cholesterol level as:

时间窗: At the baseline, 3rd month, and at 6th month

Total Cholesterol - 200mg/dl.

时间窗: At the baseline, 3rd month, and at 6th month

LDL Cholesterol - 130 mg/dl.

时间窗: At the baseline, 3rd month, and at 6th month

HDL Cholesterol - 50 mg/dl.

时间窗: At the baseline, 3rd month, and at 6th month

Triglycerides - 200 mg/dl.

时间窗: At the baseline, 3rd month, and at 6th month

次要结局

  • It will be done by assessing quality of life of patients on the basis of score obtained from COOP/WONCA Functional Assessment Chart. It measures six core aspects of functional status:(Physical fitness, Feelings, Daily activities, Social activities, Change in health and Overall health.)

研究者

申办方类型
Government medical college

研究点 (1)

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