跳至主要内容
临床试验/CTRI/2025/10/096574
CTRI/2025/10/096574招募中Phase 3 4

An Open Label Single Arm Clinical Study To Evaluate The Efficacy Of Koshtha Shodhana With Eranda Sneha Followed By Vaitarana Basti In Yogabasti Pattern In The Management Of Gridhrasi (Sciatica)

Dr Pavanbhai Jerambhai Sorathiya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:

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
Signs and Symptoms of Gridhrasi (Sciatica) and VAS (Visual Analogue Scale)

研究概览

简要总结

The research proposal titled  An Open Label Single Arm Clinical Study to Evaluate the Efficacy of Koshtha Shodhana with Eranda Sneha Followed by Vaitarana Basti in Yogabasti Pattern in the Management of Gridhrasi (Sciatica). It aims to assess the therapeutic potential of classical Ayurvedic Panchakarma therapies in treating Gridhrasi, which correlates to sciatica in modern medicine. Sciatica, a prevalent and debilitating condition characterized by radiating pain from the lower back to the legs, affects up to 40% of the population and is linked to lifestyle factors such as prolonged sitting, poor posture, and mechanical strain. Modern treatments like NSAIDs and corticosteroids provide only temporary relief and often cause adverse effects, highlighting the need for holistic alternatives.

In Ayurveda, Gridhrasi is classified under Nanatmaja Vata Vyadhi, primarily caused by vitiation of Vata (and sometimes Kapha). The classical management involves Snehana, Swedana, and Basti Karma, among which Basti is the prime therapy for Vata Vyadhi. This clinical study proposes an integrated Panchakarma protocol involving three days of Koshtha Shodhana (purgation) with Eranda Sneha (castor oil) followed by eight days of Yogabasti a combination of Vaitarana Niruha Basti and Sahachara Taila Matra Basti.

A total of 30 patients aged 30–60 years will be selected from OPD/IPD based on diagnostic criteria for Gridhrasi. The study will assess improvements in pain, stiffness, pricking sensations, numbness, and functional mobility using both subjective and objective parameters such as VAS, SLR, Bragard, and Sicard tests. Statistical analysis will evaluate pre- and post-treatment outcomes.

The expected result is significant symptom relief and functional improvement through Shodhana and Shamana actions, offering a safe, cost-effective, and root-cause-oriented management approach for Gridhrasi.

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participant fulfilling diagnostic criteria of Gridhrasi (Sciatica) like Ruk (Pain in lower back region radiating to lower limb) Stambha (Stiffness) Toda (Pricking like pain) Spandana (Twitching in all parts) and Associated symptoms like Aruchi (Anorexia) Tandra (Lethargy) and Gaurava (Heaviness in body) Participants of either gender and age between 30 to 60 years Participants willing to follow the prescribed Panchakarma protocol.

排除标准

  • Participants not fit for Matra basti and/or Niruha Basti as per Ayurveda classics Pregnant and Lactating women Participants with major systemic illnesses known cases of Uncontrolled Diabetes Mellitus and Hypertension Cardiac disorders Morbid obesity and other diseases which interferes with the course of the treatment Those who have undergone surgical treatment in affected joints Participants who report any untoward symptoms during the period of the study.

结局指标

主要结局

Signs and Symptoms of Gridhrasi (Sciatica) and VAS (Visual Analogue Scale)

时间窗: 1st, 11th, 27th day

SLR Test, Sicard Sign, Bragard test, Dehasyapravakrata (Scoliosis), Range of movement of hip joint by Goniometer

时间窗: 1st, 11th, 27th day

次要结局

未报告次要终点

研究者

发起方
Dr Pavanbhai Jerambhai Sorathiya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pavanbhai Jerambhai Sorathiya

G. J. Patel Institute Of Ayurvedic Studies And Research

研究点 (1)

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