A clinical study to evaluate the efficacy of vamana karma followed by pathya -ahara and yoga in the management of sthaulya.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in the body weight from baseline
研究概览
简要总结
INTRODUCTION:Sthaulya is a Santarpanjanya Vyadhi described in Astonindatiya Adhyaya in Sutrasthana of Charaka Samhita. In Sthaulya, Medovaha Srota is affected due to which there is over production of Medodhatu. In modern medical science, Sthaulya is compared with obesity caused by excess calorie intake and also endocrinal disorders like Hypothyroidism, Cushing’s syndrome, also drug induced or due to genetic inheritance. Obesity is often defined as a condition of abnormal or excess fat accumulation in adipose tissue to the extent that the health becomes impaired. In santarpanjanit vyadhi sodhana procedures are beneficial. Vamana is one such karma which removes vitiated kapha and medo dosha which are prime dosas involved in Sthaulya. Along with vamana, dietary management and exercise play important role in the management of Sthaulya. Hence, the study aims in integration of various approaches described in Ayurveda NEED OF STUDY: A current world health study claims that obesity is included among the fifth selected risk to health. The prevalence rate of obesity in India is 40.3%, in south the ratio is highest and in east is lowest at 32.96% and prevalence ratio is seen more in females as compared to males ratio mentioned is 41.88% versus 38.67%. prevalence rate is high in female as compared to males. Management of Obesity in contemporary science includes various medications like appetite-supressing drugs and bariatric surgeries. They may lead to various side effects like depression, tachycardia, insomnia, bloating etc. There are also chances of bowel obstruction, gallstones, ulcers due to various bariatric surgeries .etc. There is a need of holistic management which would help in a sustainable effect without any undesirable side effects. This study is designed in such a way that most of the causes of obesity can be addressed and the treatment should be cost effective and also feasible for the patient. In this study we are combining vamana, dietary specifications and yoga, this will help the patient to achieve a long-term benefit with sustainable results.
AIM: To evaluate the efficacy of vamana karma followed by pathya ahara and yoga in the management of Sthaulya
OBJECTIVES
• To study the combined effect of vamana karma, pathya ahara and yoga in the management of Sthaulya.
• To study the changes in biochemical parameters by vamana karma, pathya ahara and yoga in the management of Sthaulya.
**HYPOTHESIS****Null Hypothesis (H0):**Vamana karma followed by pathya –ahara and yoga is not effective in the management of Sthaulya
Alternate Hypothesis(H1): Vamana karma followed by pathya –ahara and yoga is effective in the management of Sthaulya
RESEARCH QUESTION : Whether vamana karma followed by pathya-ahara and yoga is effective in the management of Sthaulya ?METHODOLOGY
Study Design: An open labelled single arm clinical trial Sample size: 20 Duration of treatment: 30 -35days Selection criteria: 20Patient will be selected from OPD and IPD of Parul Ayurveda Hospital Diagnostic criteria: classical clinical features of Sthaulya as Chala sphika udar stana, Alasya, Dourbalya, Kshudraswasa, Swedaadhikya
Inclusion criteria:
1.Subjects having sign and symptoms of Sthaulya explained in Ayurveda text
2.Age between 18 years to 60 years irrespective of gender, caste, religion
3.Subjects having BMI between 23.1 to 35kg/m2
4.Subjects who are fit for vamana karma, shaman ausadhi and yoga.
5.Subjects who are ready to give written consents.
Exclusion criteria:
**1.**Age less than18years and more than60years 2.Sthaulya associated with other known disease like hypertension, cardiovascular disease, uncontrolled hypothyroidism, uncontrolled diabetes mellitus 3.Patients who are unable to carry out his/her own physical activities 4.Pregnant lady 5.Patient unfit for vamana karma Assessment criteria : 1.Subjective criteria- Chala sphika udar stana, Alasya, Dourbalya, Kshudraswasa, Swedaadhikya 2.Objective criteria-BMI, weight, body circumference(chest, waist, pelvis, mid-arm, pelvis, mid-thigh) and lipid profile 3.Criteria for assesessment of vamana:- a. Number of vamana vega b.Duration of Vamana Vamana vyapat (complicatios if occur will be noted and treated immediately). c. Vitals of patient during Vegas Immediate discomfort to the patient . d.Achievement of Pittantika Shuddhi (Samyaka Vamana Lakshana ) e. Maniki Shuddhi f.Type of Shuddhi g vamana vyapat (complications if occur will be noted and treated immediately) Study duration – 18 months Follow up: on 0th day, after vamana, after completion of treatment, on 60th day
Shodhana
1.Deepana and Pachana for 3-5 days- Chitrakadi Vati 2 BD A/F and Amapachak Vati 2BD B/F Along with Udvartana Witth Yava Churna + Triphala Churna
2.Snehapana for 3-7 Days with Murchita Goghrita 3.Vamana Karma with Vamana yoga –Madanphala pippali (6gram), yastimadhu churna (3gm), vacha(3gm), madhu(q.s.) 4.Samsarjana Krama for 3/5/7 days.
Shamana and yoga
1.Breakfast – Boiled Moong / Channa /Lajja(Jowar/Bajra). 2. Lunch – Jowar Roti /Seasonal Vegetables/daliya 3. Dinner – Jowar Roti /Seasonal Vegetables /daliya. 4.Shamana Aushadhi – Varunadi Kashaya 20ml Bd B/F.
Yoga and vyayama
1.Sukshma Kriya for10 mins 2.Suryanamaskar 2 times every morning and increased by 2 per weekly(acc. to strength of patient)
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects having sign and symptoms of sthaulya explained in Ayurveda Text Age between 18years to 60 years irrespective of gender,caste,religion Subjects having BMI Between 23.1-35kg per metre square Subjects who are fit for vamana karma, shamana aushadhi and yoga Subjects Who are ready to give written consents.
排除标准
- •Age less than 18years and more than 60years irrespective of caste, gender and religion Sthaulya associated with other known diseases like cardiovascular disease, uncontrolled DM, uncontrolled hypothyroidism Patients who are unable to carryout his or her own physical activities Pregnant lady Patients Who are unfit for vamana karma.
结局指标
主要结局
Reduction in the body weight from baseline
时间窗: 60days
次要结局
- 1 Reduction in the BMI(2 Changes in the lipid profile Reduction in total cholestrol ,LDL,Triglycerides HDL Levels)
研究者
Khushboo k Marathe
Parul Institute of Ayurved
