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临床试验/CTRI/2025/02/080972
CTRI/2025/02/080972尚未招募3 期

A clinical study to evaluate the efficacy of vamana karma followed by pathya -ahara and yoga in the management of sthaulya.

Parul Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3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
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

发起方
Parul Institute of Ayurved
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Khushboo k Marathe

Parul Institute of Ayurved

研究点 (1)

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