A Comparative Clinical Study To Evaluate The Efficacy Of Chaturbhadra Kalpa Basti And Yoga Basti In The Management Of Amavata (Rheumatoid Arthritis).
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS scale, ROM by Goniometer, Anthropometric measurement of big joints by measuring tape & Jeweler’s ring sizer measurement for small joints.
研究概览
简要总结
“Amena sahita vata Amavataâ€.
The virulent ama circulates in the whole body propelled by the vitiated Vata dosha producing blockage in the body channels (srotorodha) that takes ashraya in the Sandhi giving rise to Amavata. Amavata is a disease of Rasavaha Srotas affecting abhyantara and madhyama roga marga, as it involves Marma, Asthi and Sandhi.
Rheumatoid Arthritis is an inflammatory autoimmune disease which causes swelling, pain, stiffness in multiple joints but most commonly in small joinys of hands and feet, knee, elbow, wrists etc.
The typical onset of the disease occurs in adult in their sixties. Women are two to three times more often affected than men. In 2019, 18 million people worldwide were living with Rheumatoid Arthritis. About 70% of people living with Rheumatoid Arthritis are women and 55% are older than 55 years. 13 million people with Rheumatoid Arthritis experience severity of moderate or severe level that could be benefitted from rehabilitation. RA affects about 0.24 to 1 percent of the global population while in India its about 0.75 percent of the population.
Early diagnosis and management can reduce symptoms, slow the disease and prevent disability. Contemporary medicine includes NSAIDS, DMARD’s, Immunosuppressants, steroids and some surgical procedures etc. Despite of all that chances of recurrence is more. But with Ayurveda treatment recurrence can be decrease as it effects the root causes not just symptoms and specially Basti chikitsa is labelled as Ardha Chikitsa for Vata vyadhi. With the Basti along with other oral treatment and pathya ahara-vihara, deformities can be prevented, so person can improve their quality of life by performing daily routine activities easily.
Acharya Kashyapa has explained a different krama of four continuous Anuvasana (unctuous) Basti in the beginning and at the end, four continuous Niruha Basti (cleansing) in between, is known as Chaturbhadra Kalpa Basti and it is free from complications. Yoga Basti is used when Vata does not have good strength and is associated with Kapha. In Yoga Basti, 3 Niruha Basti and 5 Anuvasana Basti by most of the Acharya.
For Group A- Chaturbhadra Kalpa Basti for 12 days
For Group B- Yoga Basti for 8 days
Anuvasana- Brihat Saindhavadi Taila- 120 ml- Immediately after food
Niruha Basti – Vaitarana Basti- 320 ml- before food
After completion of treatment and follow up as a result expecting decrease in joint pain, stiffness, swelling, etc. and increase range of movement as well.
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
- 30.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •Participants fulfilling diagnostic criteria.
- •Participants fulfilling 2010 ACR EULAR classification criteria for Rheumatoid Arthritis.
- •Participants of either Gender and age between 30 to 60 years.
- •Participants fit for Anuvasana and Niruha Basti karma.
排除标准
- •Participants are not fit for Anuvasana and/or Niruha Basti as per Ayurvedic classics.
- •Participants with major systemic illnesses.
- •Those who have undergone surgical treatment in affected joints.
- •Participants who report any untoward symptoms during the period of study.
- •Participants on steroids or were on steroid before 6 months.
结局指标
主要结局
VAS scale, ROM by Goniometer, Anthropometric measurement of big joints by measuring tape & Jeweler’s ring sizer measurement for small joints.
时间窗: For Group A 0th, 12th, 19th and 26th days. | For Group B 0th, 8th, 15th and 22nd days.
ESR, CRP (Quantitative).
时间窗: For Group A 0th, 12th, 19th and 26th days. | For Group B 0th, 8th, 15th and 22nd days.
次要结局
- Sandhishula (pain in joints), Sandhistabdhata (stiffness in joints), Sandhisotha (swelling in joints), Restriction of movements, Angamarda (body ache), Aruci (tastelessness), Trsna (polydipsia), Alasya (malaise), Gaurava (feeling of heaviness), Jwara (fever), Apaka (indigestion), Sunata-anganam (swelling).
研究者
Dr Naitik Tanmay Gopiani
G. J. Patel Institute Of Ayurvedic Studies And Research
