CTRI/2024/10/075525尚未招募不适用
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VARADI KASHAYA AND MUSTADI KWATHA IN THE MANAGEMENT OF STHAULYA W.S.R OVERWEIGHT CHILDREN:AN OPEN LABEL RANDOMIZED TRIAL.A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VARADI KASHAYA AND M
Institute of Ayurvedic studies and researchShri Krishna AYUSH university1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduce in BMI and weight of the children as per the age along with prevention of comorbidity of childhood nutritional obesity.
研究概览
简要总结
BRIEF SUMMARY ON PURPOSE - Childhood Obesity:
- Overweight and obesity in children occur due to various causes.
- The most common cause is an imbalance between calories consumed and calories expended.
- Global Challenge: Childhood obesity is one of the most pressing public health challenges of the 21st century.
- It is a global issue, particularly affecting low- and middle-income countries, especially in urban areas.
- Allopathic Medication for Weight Control: Medication for weight control should be accompanied by realistic goals.
- Initial weight loss can be achieved, but medications only work while being taken; discontinuation may lead to weight regain.
- Ayurvedic Perspective on Obesity (Sthaulya):
- Sthaulya (obesity) in Ayurveda is caused by the consumption of Kapha-increasing diet and lifestyle (Ahara and Vihara), leading to impaired Jatharagni (digestive fire) and the formation of Ama (toxins).
- This also impairs Medodhatvagni (fat metabolism).
- Ayurvedic Treatment Approach: A drug for obesity should possess properties like Deepana (appetizing), Pachana (digestive), Kapha-Vata Shamana (balancing Kapha and Vata), Srotoshodhana (clearing channels), and Medonashaka (fat-reducing).
- Study Drugs:
- Varadi Kashaya: Taken from Sahasram Yogakashya Prakarana 63/10; ingredients include Haritaki, Amalaki, Bibhitaki, Chitrak, Nisha, Asana.
- Mustadi Kwatha: Taken from Charaka Samhita Sutra Sthana Chapter 23/12-14; ingredients include Musta, Aragwadh, Patha, Amalaki, Haritaki, Vibhitaka, Devdaru, Gokhshur, Khadir, Nimba, Haridra, Daruharidra, Kutaj.
BACKGROUND OF TRIAL
- Childhood Obesity: A global issue due to an imbalance between calorie intake and energy expenditure, leading to health risks like diabetes and cardiovascular disease.
- Allopathic Treatment: Short-term weight loss but with side effects like high blood pressure, and weight often returns after discontinuing medication.
- Ayurvedic Perspective: Obesity (Sthaulya) results from a Kapha-increasing diet and lifestyle, leading to impaired metabolism and toxin buildup (Ama).
- Ayurvedic Treatment: Focuses on balancing metabolism using natural remedies that are safer and more cost-effective than allopathic treatments.
- Study Objective: To compare the efficacy of Varadi Kashaya and Mustadi Kwatha, two Ayurvedic formulations, in managing obesity in overweight children.
- Significance: Offers a natural, long-term alternative to managing childhood obesity without harmful side effects.
- PRIMARY FINDING - Reduce in BMI and weight of the children as per the age along with prevention of comorbidity of childhood nutritional obesity. SECONDARY FINDING -Change in subjective parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Children age group from 10-16 years of either sex will be selected for study.
- •Children having cardinal feature of Sthaulya (As per Subjective Parameter) will be selected.
- •Individuals having body mass index (BMI) between 85th – 95th percentile of Extended Indian Academy of Paediatrics (IAP) Body Mass Index (BMI) Chart 2015.
排除标准
- •Children age less than 10yrs & above 16 years of age were excluded from the study.
- •BMI less than 85th percentile and more than 95th percentile of Extended Indian Academy of Paediatrics (IAP) Body Mass Index (BMI) Chart
- •Waist circumference above the 90th percentile is used as a cut-off for identifying central adiposity and children who are at risk of developing metabolic syndrome.
- •Obesity due to Endocrinal cause, Monogenic disorders, Syndromes, Neurological/hypothalamic causes, Infective, brain surgery, radiotherapy, trauma; Drug induced and psychological causes.
- •Children with special health care needs (developmental and physical disabilities);
- •Children with existing comorbidities related to obesity.
结局指标
主要结局
Reduce in BMI and weight of the children as per the age along with prevention of comorbidity of childhood nutritional obesity.
时间窗: 60 days
次要结局
- Change in subjective parameters.(60 days)
研究者
Dr Aarti Mal
Ayurvedic studies and research Shri Krishna AYUSH university
研究点 (1)
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