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临床试验/CTRI/2023/10/058725
CTRI/2023/10/058725尚未招募3 期

NOVEL INTEGRATED APPROACH IN THE MANAGEMENT OF OBESITY WITH SPECIAL REFERENCE TO HYPERTRIGLYCERIDEMIA– A RANDOMIZED CONTROL CLINICAL TRIAL

KLE ACADEMY FOR HIGHER EDUCATION AND RESEARCH2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月25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
2
主要终点
Novel Integrated approach with Udwartana for 07 days and Individualized Homeopathic remedies administered internally for 30 days will be effective in management of obesity with special respect to Hypertriglyceridemia

研究概览

简要总结

Obesity has the deleterious effect both on body and mind. Hence WHO declared it is as global epidemic, giving rise a new term Globesity.  If secular trends continue, by 2030 an estimated 38% of the world’s adult population will be overweight and another 20% will be obese. Obesity promotes a cascade of secondary pathologies including Diabetes**,**hyperlipidemia, hypertriglyceridemia, Inflammation, Thrombosis, Hypertension, insulin resistance, Metabolic syndrome etc.

In Ayurveda various modalities and sufficient focus has been given in the management of obesity in form of Rukshan kriya, drug and diet. Guru and Apatarpan is the line of treatment in the management of obesity in Ayurveda.Udwartana has been described and proven to be effective in obesity. Homoeopathy is a holistic and safe way to overcome obesity without any side-effects. It is also proven that Homoeopathic medicines can help to lose weight by improving digestion, absorption, elimination and metabolism. HTG is typically not an isolated abnormality and is frequently associated with other lipid abnormalities and the metabolic syndrome specially in Obesity.  So, if goal is to lose fat, we have to reduce the amount of fat stored in our fat cells as the permanent triglyceride form.

Existing homeopathic line of treatment is giving a fruitful result in lowering the identified biomarkers in a study subject but the parameters like weight of the body and anthropometric measurements are to be targeted with multiple approach. Ayurveda also has favorable results in lowering the identified bio markers along with body weight and anthropometric measurements. Hence to get rapid desirable effect in the parameters like weight reduction and anthropometric measurement, an integrated approach is designed without interrupting the core treatment principle of both the medical discipline. The treatment protocol is tailored to minimize drug interaction in the form of Udwartana kriya (external intervention) and individualized homeopathic remedies (Internal intervention). Based on the above facts, to get a way through the burning issue of obesity the present study on “NOVEL INTEGRATED APPROACH IN MANAGEMENT OF OBESITY WITH SPECIAL RESPECT TO HYPERTRIGLYCERIDEMIA– A       RANDOMIZED CONTROL CLINICAL TRIAL†has been planned.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • Patients from either sex with classical sign and symptoms of Obesity Patients of age group 18 to 60 years Patients with BMI greater than 25 kg per m2 to less than 35 kg per m2 Patients with Triglycerides greater than 150mg per dl to lesser than 500 mg per dl.

排除标准

  • Patients having major systemic disorders or other illnesses such as Hypothyroidism PCOS Cushing syndrome Hypersensitivity and Diabetes which interfere with the present study Patients with serious disease limiting life expectancy Pregnancy and lactating mothers Cognitive impairment congenital deformities Not willing to participate in the study.

结局指标

主要结局

Novel Integrated approach with Udwartana for 07 days and Individualized Homeopathic remedies administered internally for 30 days will be effective in management of obesity with special respect to Hypertriglyceridemia

时间窗: Novel Integrated approach with Udwartana for 07 days and Individualized Homeopathic remedies administered internally for 30 days will be effective in management of obesity with special respect to Hypertriglyceridemia

次要结局

  • Udwartana for 07 days will be effective in the management of Obesity with special respect to Hypertriglyceridemia(Individualized Homeopathic remedy for 30 days will be effective in the management of Obesity w r to anthropometric measurements)

研究者

发起方
KLE ACADEMY FOR HIGHER EDUCATION AND RESEARCH
申办方类型
Research institution and hospital

研究点 (2)

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