跳至主要内容
临床试验/CTRI/2025/01/079134
CTRI/2025/01/079134尚未招募2/3 期

Comparative clinical trial to Evaluate the efficacy of Phalatrikadi Ghanvati with and without Virechana Karma in Metabolic Syndrome

Ayurvedic and Unani Tibbia college and hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The proportion of patients showing improvement in parameters of extended lipid profile,blood sugar level, blood pressure, waist circumference and BMI after use of phalatrikadi ghanvati with and without virechana karma.

研究概览

简要总结

Metabolic syndrome encompasses a combination of interconnected physiological, biochemical, clinical and metabolic factors that significantly elevate the risk of cardiovascular diseases, type 2 diabetes mellitus and all cause mortality. It is an emerging clinical challenge in the society today. A fat rich diet, sedentary lifestyle, stress, sleep disturbances, excessive alcohol use, being overweight, genetic factors can contribute to the metabolic syndrome. In Ayurveda, the initial stage of Metabolic syndrome can be correlated with Medavaha Sroto Dushti (vitiation of micro channels of lipid metabolism and transportation), which manifests as a group of symptoms of Atisthula(obesity) and premonitory signs and symptoms of Prameha. Clinical features of Metabolic syndrome like Atitrushna, Daurgandhya, Swedadhikya resemble with Apathya Nimittaja Prameha mentioned in ayurveda. In contemporary science, the approach of management is multifaceted involving lifestyle intervention and use of drugs like-hypolipidemic, anti-diabetic and anti-hypertensive. However, these approaches of modern therapy have several long-term & short term side effects. So, there is a need for urgent development of effective and safe approaches for preventing and managing the syndrome. Majority of achayaras has told samshodhan chikitsa as prime treatment for shtula pramehi. So, here I taken virechana as a therapeutic measure because it will improve the function of digestive system through the way of intensive purgation. It clears the microcirculatory channels which results in better metabolites and blood circulation which result in the improved efficacy of liver. As it reduces the extra unnecessary burden on liver which result in correcting the physiology of liver and hence the reduces the production of excess lipids. The major pathway of excretion of excess cholesterol from the body is usually by conversion to bile acids excreted in faeces as bile salts and virechana increases this secretion and causes purgation. And also phalatrikadi ghanvati has been told a prime shamana aushadh in sarva prakara prameha and it has Medohara, Pramehahara, Rasayana, Deepana, Pachana properties. So, the goal of current study is to assess the effect of phalatrikadi ghanvati used with and without virechana karma in managing metabolic syndrome. According to reports, patients of metabolic syndrome had considerably low serum adiponectine level than healthy controls. So, in this study we will also see the effect of phalatrikadi ghanvati with and without virechana karma on serum adiponectine in patients of metabolic syndrome.

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

  • Patients of either sex of age group 20 to 60 years.
  • Patient fulfilling more than or equal to 3 out of 5 criteria for MetS (according to NCEP ATP III criteria):- I.
  • Abdominal obesity (waist circumference more than 102 cm (40 inches) in men or 88cm (35 inches) in women.
  • Serum triglycerides level more than 150mg/dl.
  • Low HDL Cholesterol less than 40mg/dl and less than 50mg/dl for men and women,respectively.
  • Blood pressure more than or equal to 130 mmHg systolic or more than or equal to 85 mmHg diastolic.
  • Fasting Plasma Glucose level more than 100mg/dl
  • Patient who are considered fit for virechana procedure for group A.
  • Patients willing to give written consent.

排除标准

  • Any patients on treatment for Diabetes mellitus, Dyslipidaemia and Hypertension.
  • Patients who present with blood pressure in the following range.
  • systolic more than or equal to 180 mmHg or diastolic more than or equal to 120 mmHg.
  • Patients having Hba1c more than 7
  • Subject having systemic illness, malignancy, major endocrine disorders will be excluded from this study.
  • Know case of IHD, CAD, CCF or other major cardiovascular problems will not be included for this study.
  • Patients with renal (Sr. creatinine more than 1.8mg/dl) OR hepatic impairment SGOT, SGPT and GGT more than five times than normal value.
  • Patients on anti-retroviral, anti-tubercular and antibiotic medications.
  • Pregnant and lactating women will not be included.
  • Patients requiring emergency treatment.
  • For group A : Patients who are contraindicated for virechana karma- like lower GI bleeding, prolapse of rectum, incontinence of stool will not be included.

结局指标

主要结局

The proportion of patients showing improvement in parameters of extended lipid profile,blood sugar level, blood pressure, waist circumference and BMI after use of phalatrikadi ghanvati with and without virechana karma.

时间窗: Group A- Baseline,after Virechana karma, Day 15, Day 30, Day 45,Day 60,Day 75 | Group B - Baseline,day 15,day 30,day 45,day 60,day 75

次要结局

  • The proportion of patients showing changes in the serum adiponectine after use of(phalatrikadi ghanvati with & without virechana karma.)

研究者

发起方
Ayurvedic and Unani Tibbia college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ritu

Ayurvedic and Unani Tibbia college and hospital, karol bagh New Delhi 110005

研究点 (1)

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