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临床试验/CTRI/2024/08/072551
CTRI/2024/08/072551尚未招募不适用

An Open Label Double Arm Comparative Clinical Study On The Effect of Siddha Basti and Siddha Basti with Valuka Sweda in Amavata(Rheumatoid arthritis)

Dr Pranathi G Kashyap1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月2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
30
试验地点
1
主要终点
• Significant improvement in Sandhi shola (joint pain) measured using VAS(Visual analog scale)

研究概览

简要总结

In the present era, due to a sedentary lifestyle, consumption of incompatible food, hectic work schedules, improper physical activities, stress and many such reasons, individuals are prone to develop distressing clinical conditions which are mainly caused due to impaired digestion and metabolism. Amavata is one such crippling disease claiming maximum loss of human power where there is formation and deposition of Ama at all levels of body physiology.

                                                            The symptoms of Amavata have strong parlance with Rheumatoid arthritis observed as an autoimmune and a systemic inflammatory disease that is characterized by a progressive and disabling course with a prevalence rate of 0.24% 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 times greater risk of developing severe arthritis than the general population.

 In contemporary science, NSAIDs, DMARD, immunosuppressants and Steroids are widely used which do only symptomatic relief with no cure but have high chances of developing co-morbidities. In Ayurveda, Siddha basti mentioned in Vangasena samhitaand Valuka sweda mentioned in Yogaratnakaraare mainly indicated for Amavata(Rheumatoid arthritis) as both the treatment modalities do vata kapha prashamana which is the main cause for the disease. Basti karma has been selected as it is the prime treatment for vata dosha not only in curative and preventive aspects of diseases but also in promotive aspects hence considered as chikitsardha by our Acharyas. Valuka sweda does kapha, shotha and shoolahara inturn subsides ama. Hence this study is undertaken to evaluate the effect of Siddha basti and the additive effect of Sarvanga Valuka sweda along with Siddha basti  in Amavata (Rheumatoid arthritis).

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)(—)
性别
All

入选标准

  • 1.Amavata with features of Rheumatoid arthritis as specified in 2010 ACR-EULAR classification criteria.
  • 2.Irrespective of serological negativity and positivity are included for the study.
  • 3.Patients fit for Basti karma.
  • 4.Patient of either gender with the age group 30 to 60 years.
  • 5.Recent onset and less than or equal to 5 years of chronicity.
  • 6.Considering disease activity and functional impairment STAGE-1, STAGE-2 7.Patients voluntarily willing to participate in the study and ready to sign consent form.

排除标准

  • 1.Patients with known case of uncontrolled hypertension and diabetes mellitus.
  • 2.Patients with cardiac manifestations.
  • 3.Patients diagnosed with other degenerative and inflammatory joint diseases, history of knee implants and total knee replacement surgeries.
  • 4.Patients with the signs and symptoms of Pravruddha amavata21 with joint deformities STAGE-3, STAGE-
  • 5.Active tuberculosis, Ulcerative colitis, Irritable bowel syndrome or other sever systemic and endocrine disorders.
  • 6.Patients of Ano-Rectal disorders.
  • 7.Pregnancy and lactating women.
  • 8.Patients with cerebrovascular accident.
  • 9.Patients who are receiving chemotherapy and radiotherapy.

结局指标

主要结局

• Significant improvement in Sandhi shola (joint pain) measured using VAS(Visual analog scale)

时间窗: 0th day(before treatment),9th day(after treatment) and 24th day(after treatment)

• Significant improvement in Sandhi sthabdhata(morning stiffness) using Gradings

时间窗: 0th day(before treatment),9th day(after treatment) and 24th day(after treatment)

• Significant improvement in Sandhi shotha(joint swelling) using gradings

时间窗: 0th day(before treatment),9th day(after treatment) and 24th day(after treatment)

• Significant improvement in Tenderness using gradings

时间窗: 0th day(before treatment),9th day(after treatment) and 24th day(after treatment)

次要结局

  • • Significant improvement in DAS 28Score(• Improved Quality of life related to joints.)

研究者

发起方
Dr Pranathi G Kashyap
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pranathi G Kashyap

Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital

研究点 (1)

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