跳至主要内容
临床试验/CTRI/2019/03/018321
CTRI/2019/03/018321尚未招募不适用

‘A Randomized Controlled clinical trial to evaluate the efficacy of Agnikarma with Tamra Shalaka and Panchdhatu Shalaka in management of Manya Sandhigata Vata.’

PDEAs college of ayurved and research center1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
To compare the effect of Agnikarma with Tamra Shalaka and Panchadhatu Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis.

研究概览

简要总结

In present era, peoples are prone to many neck related problems because of lifestyle, improper and professionally adopted postures, food habits, stress, travelling, etc. which may develop symptoms of cervical Spondylosis. It can be correlated with the Sandhigata Vata (Manyagata) in Ayurveda which is one of Vatavyadhis. The management of the symptoms is done by using steroids, analgesics, and anti-inflammatory drugs in day to day life. It is observed that these treatments does not give long term relief and may produce adverse effects. As structural changes are permanent but a treatment which will provide symptomatic relief to perform regular work without any complications is the need of the hour.

 Cervical Spondylosis is an age related chronic degenerative disorder of intervertebral disc and bodies of cervical spines.

xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" / Degenerative changes are common in the cervical spine. Indeed they are found almost universally in some degrees in persons over 50 years of age. Nowadays joint disorders are prevailing even in early age group after 3rd decade of life. About 50% of people over the age of 40-45 experience neck pain and stiffness and symptoms of cervical Spondylosis.

Repeated trauma related to specific occupation like carrying axial loads, professionally adopted postures, etc. and smoking plays important role in producing Cervical Spondylosis even in lesser groups. It shows symptoms like pain, stiffness of neck, sometimes with referred symptoms in an upper limb like tingling, numbness, radiating pain in the course of nerve.

 As structural changes are clearly permanent, only symptomatic relief can be provided by administration of powerful analgesics and another conventional tools available in modern medicine like Ultrasound, Short-wave diathermy, massage and intermittent traction. Physiotherapy and strengthening exercises shown some benefits. All been used but none have shown to be effective in large clinical trials. Surgical procedures like laminectomy, cervical arthrodosis, etc. Are good but expensive and may show postoperative complications.

 According to Acharyas, Sandhi (joints) is sthana of kapha dosha. Kaphavritta Vyana Vayu is a chief causative factor to produce pain and restricted movements of joints.

Kaphavritta Vyan Vayu is responsible for Guruta (heaviness) in whole body, pain in all joints and bones, etc.

In Ayurved, acharyas have mentioned various therapeutic and parasurgical procedures, vatahara yogas to manage Sandhigata Vata. Parasurgical proceedures like Agnikarma, etc. are practiced in such condition as they are easy, provide quick relief from symptoms and have no complications. Agnikarma is indicated in vata-kaphaj disorders. Agnikarma is effective, powerful and useful in diseases which are not amenable to Aoushadha , Shastra and kshara. It gives no room for the diseases to reoccur. It can be done to the skin, muscles, veins, tendons, joints and bones.

For Agnikarma different types of materials are used as they each show their unique effect on particular diseases. Pippali, ajashakrud, godant, shar, shalaka, jambavostha, lohadi dhatu, khoudra, guda, sneha, are advised to use for agnikarma. Jambavostha, suchi, shalaka, ghrit, madhu, madhuchista, tail, vasa, hema (gold), tamra (copper), rupya (silver), etc are also used.

So my topic is to compare and to evaluate the efficacy of Agnikarma with Tamra shalaka and Panchadhatu shalaka in management of Manya Sandhigata Vata with special reference to cervical Spondylosis which has been not done yet, hence this topic is selected.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • •A) Patients having symptoms of Cervical Spondylosis B) Patients with Sandhigata Vata (Manyagata) Lakshanas : Shool (pain), Shotha (swelling), Atopa (grating), Sthambh (Stiffness) Sandhihata (restricted movements) C) Related symptoms like; Bhrama (Giddiness), Shirashool (headache), Chimchimayan Hasta (tingling sensation in hands) Suptata (numbness).
  • •D) Patients who will give written consent for the trial,irrespective of Gender, Religion, Occupation, Socio-economic status.

排除标准

  • •Known cases of: a) Skin diseases and localized wounds.
  • •b) Tuberculosis of spine (Pott’s spine), c) Diabetic Neuropathy, d) HIV and HBsAg positive patients, e) Rheumatoid Arthritis, Gouty Arthritis, Psoriatic Arthritis, f) Ischemic Heart Disease, g) History of injury, fracture, surgery to Spine and Cervical Spondylolisthesis h) Congenital anomalies of spine I) Carcinoma of Spine.

结局指标

主要结局

To compare the effect of Agnikarma with Tamra Shalaka and Panchadhatu Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis.

时间窗: 1. On 0 and 7th Day agnikarma will be performed and observations will be noted. | 2. On 15th day and 30th day, follow up with assessment to rule out any reoccurrence of complaints.

次要结局

  • 1. To study the efficacy of Agnikarma with Tamra Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis.(2. To study the efficacy of Agnikarma with Panchadhatu Shalaka in management of Manya Sandhigata Vata with special reference to Cervical Spondylosis.)

研究者

发起方
PDEAs college of ayurved and research center
申办方类型
Private medical college

研究点 (1)

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