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临床试验/CTRI/2025/04/085512
CTRI/2025/04/085512尚未招募2/3 期

Efficacy of Agnikarma and Katibasthi with Devadaru Baladi Taila in the Management of Katisandhigata Vata (lumbar spondylosis) An Open Labelled Randomised Comparative Clinical Trial

Institute of Teaching and Research in Ayurveda,Jamnagar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月7日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Relief in pain stiffness numbness over lumbar region

研究概览

简要总结

Sandhigata Vata is a clinical condition develops when the vitiated Vayu becomes localized in Kati Pradesha due to Dhatukshaya (degenerative pathology). Considering the sign and symptoms of Kati Sandhigata Vata such as Katishoola (low back pain), Katisuptata (low back numbness), Akunchana Prasarane Pravrutti Savedana (painful joint movements) and Katistambha (low back stiffness), it can be correlated with Lumbar spondylosis.Lumbar spondylosis is the most prevalent disorder in modern era. The prevalence of musculoskeletal pain in older adult . So, this disease is a significant threat especially to working population. Patients of lumber spondylosis are bound to choose analgesics, anti-inflammatory drugs, steroid injections or physiotherapy as conservative treatment to improve the quality of life. In advanced stage of lumbar spondylosis, the surgical therapies like spinal fusion, spinal decompression etc. are the only option. But these procedures are not fulfilling the goal of patients because of very high cost and its therapeutic limitation. Even after surgery also patients have to take analgesics for longer duration.

Acharya Sushruta explained that Agnikarma can be done when severe painful condition in Twaka, Mamsa, Sira, Snayu, Sandhi and Asthigata vedana due to Vata Prakopa and especially beneficiary in Vata-Kaphaj Vikaras.

Katibasthi is also a standardized procedure in lumbo sacral complaints. In this procedure, hot medicated oil is make hold in the lumbar aspect which relieves the lower back complaints by the action of oil, the way of procedure and certain other factors. Agnikarma is carried out at the most tender point in the lumbar region  in 4 sittings with an interval of 7 days  with minimum of 15 bindus per sitting. Each dagdha having a gap of 0.5cm and after the procedure Yashtimadhu grta have to be applied. Katibasthi  carried out  warm  Devadaru Baladi Taila which is having properties like

Ushna Veerya, Katuvipaka,Vatakaphahara, Deepana, Vayasthapana, Brimhana, Balya, Rasayana and actions like Vedhanashamaka, Shothahara and Vatalunomana plays vital role in this pathology. So, this oil is used in Sirasnayusandhigata Vata. The Guru Guna, Ushna Veerya, Snigda Guna of Sneha will counteracts with Laghu, Sheeta and Rooksha Guna of Vata, so when Vata dosha is controlled ultimately the problem can be subsided. The medicated oil is hold in a cap like hollow structure made of black gram floor for 15-20 min of constant temperature maintained at the lumbar region.The parameters  like tenderness, numbness, stiffness, disability will be assessed

and marked on the specially designed research proforma. Follow up will be taken weekly, after 1 month and later after 2 months after the completion of procedure. The data generated during the present study will be presented in a systemic manner and shall be analysed statistically. The important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients between age group 30-70 years of either gender.
  • •2.Patient suffering from pain, stiffness, numbness irrespective to demographic data.
  • •3.X-ray investigation with reduction in intervertebral disc space, loss of lordosis and presence of lumbar scoliosis taken for the study.
  • •4.Patients who are of niramaja condition included.

排除标准

  • •1.Patients below 30 years and above 70 years.
  • •2.Patients of uncontrolled diabetes mellitus (RBS above 150mg/dl), R.A. (Rheumatoid arthritis) positive, hypertension.
  • •3.Other diseases like paralysis, Parkinson’s disease, severe anaemia, cardiac diseases, renal diseases and endocrine diseases, severe anaemia and Malignancy.
  • •4.Pregnant/lactating female.
  • •5.Agnikarma Ayogya patients as per classics i.e. Pitta Prakruti diseased with Rakta-Pitta, Atisara, Durbala, Bheeru, Vranita, Aswedya and those having srotorodha, balabramsha.
  • •6.Other diseases like sacroiliac joint arthritis, lymphomas, pelvic malignancy, etc., patients will be excluded.
  • •7.Patients suffering from trauma,fracture, systemic diseases, Sciatica with neurological damage, contraindications to Agnikarma such as patients affected with multiple wounds, sciatica with SLR test positive less than 30°and more than 70°.

结局指标

主要结局

Relief in pain stiffness numbness over lumbar region

时间窗: 1st day 7th day 14th day 21st day 28th day

次要结局

  • Absence of recurrence in followup period.(60 days)

研究者

发起方
Institute of Teaching and Research in Ayurveda,Jamnagar
申办方类型
Research institution and hospital

研究点 (1)

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