“A Randomized open labelled clinical study to compare the efficacy of Vangasenokta Siddha Basti and Dhanyamla Dhara with Vangasenokta Vaitarana Basti and Dhanyamla Dhara in the management of Amavata Vis-a-vis Rheumatoid Arthritis."
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant decrease in symptoms of Amavata vis-a-vis Rheumatoid arthritis assessed based on subjective parameters like Sandhishoola, Sandhistabdhata, Sandhishopha and other Samanya Lakshanas like Angamarda, Aruchi, Trushna etc., ) and objective parameters ( like tenderness in joints, warmth in joints, Disease activity score 28 or DAS28, general functional capacity and Barthel’s index)
研究概览
简要总结
In today’s day and age, we live in a competitive world with career driven individuals who turn a blind eye towards their physical, mental, and social wellbeing in order to succeed in attaining materialistic accolades. Failing to follow healthy and disciplined dietary practices and seasonal regimens, tends to lead them to an altered status of their digestion and metabolism that in turn leads to the accumulation of Ama leading to several serious diseases.
Amavata is one such crippling disease claiming a herculean loss of human power where there is formation and deposition of Ama at all levels of body physiology.
Am**avata was first described by Acharya Madhavakara wherein ‘Yugapat’ that pertains to simultaneous vitiation of Vata and Kapha Dosha in the Koshta, later entering the Trika Sandhi Pradesha leading to Gatra Stabdhata and Trika Sandhi Vedana1.
In the 21st century, Rheumatoid arthritis (RA), that is said to have a strong resemblance with the symptoms of Amavata has been more common & distressing amongst all joint-related pathologies and is characterised as an autoimmune and a systemic inflammatory disease with a disabling and progressive course. Marking a prevalence rate of 0.24% 2 which has drastically increased up to 0.5% -1% over a decade, with a woman to man ratio of 3:1. It is 4-5 times higher in women under 50 years, but after 60 years the ratio becomes approximately 2:1 globally. Family studies indicate a genetic predisposition and patients with first-degree relatives possessing the auto antibody are found to have 2 :1 time greater risk of developing severe arthritis than the general population3.
Modern medicine, having introduced the utility of NSAIDs, DMARDs, immunosuppressants and steroids has been able to deliver only interim benefits to patients in terms of symptomatic relief but no cure and with an addon of potential chances of developing co- morbidities and having a negative impact on the immune system.
In Ayurveda, Siddha Basti and Vaitarana Basti mentioned in Vangasena Samhita4,5 and Dhanyamla Dhara mentioned in Sahasrayogam6 are indicated in the mitigation of Amavata as all these modalities act as Vatakapha Prashamana Chikitsas. Being the prime treatment for Vata Dosha and rightly considered as Chikitsardha by our Acharyas, Basti Karma has been chosen in view of both curative and preventive aspects of the disease. Siddha Basti is said to have Rukshana, Lekhana, Amavata prashamana7qualities whereas Vaitarana Basti is indicated in Shoola, Amavata, Shopha of Kati, Uru, Prushta8 etc Hence this study is undertaken to compare the clinical efficacy of Vangasenokta Siddha Basti and Dhanyamla Dhara with Vangasenokta Vaitarana Basti and Dhanyamla Dhara in the management of Amavata vis-a-vis Rheumatoid Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Subjects of age group between 20 to 60 yrs, of both genders with chronicity equal to or less than five-year duration will be selected for the study.
- •Subjects of Amavata diagnosed on the basis of signs & symptoms described in Ayurvedic classics will be selected for the study.
- •Subjects diagnosed as Amavata with features of Rheumatoid arthritis as specified in European League Against Rheumatism/ American College of Rheumatology 2010 criteria that is 2010 ACR-EULAR diagnostic criteria24 will be selected for the study.
- •Subjects indicated for Basti Karma and Dhanyamla Dhara will be selected for the study.
- •Considering disease activity and functional impairment STAGE-1, STAGE-2 6)Subjects voluntarily willing to give written consent and participate in the study.
排除标准
- •Subjects of both genders with chronicity of disease more than 5 years with any joint deformity.
- •Subjects with any systemic disease or condition that would potentially interfere with the course of treatment.
- •Subjects contraindicated for Basti Karma and Dhanyamla Dhara.
- •Subjects with the signs and symptoms of Pravruddha Amavata with joint deformities STAGE-3, STAGE-4 5)Pregnant and lactating women.
结局指标
主要结局
Significant decrease in symptoms of Amavata vis-a-vis Rheumatoid arthritis assessed based on subjective parameters like Sandhishoola, Sandhistabdhata, Sandhishopha and other Samanya Lakshanas like Angamarda, Aruchi, Trushna etc., ) and objective parameters ( like tenderness in joints, warmth in joints, Disease activity score 28 or DAS28, general functional capacity and Barthel’s index)
时间窗: all the parameters will be assessed at 3 different time points, namely 0th day, 8th day and 16th day.
次要结局
- Generation of in-depth analysed data on the different aspects of the disease.(Generation of data on quality of life with the test treatment modalities assessed based on Barthel’s index.)
研究者
Dr Manojna S Maliye
Sri Sri College of Ayurvedic science and Research Hospital