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临床试验/CTRI/2018/07/015072
CTRI/2018/07/015072尚未招募2 期

A Clinical Comparative Study on Effect of Erandamula Ghanavati, Panchatikta Kshira Basti with and without Kati Basti in Katigrah with special reference to Lumbar Spondylosis

Government Ayurved College Nagpur1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年3月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1. Evaluate the effect of Erandamula Ghanavati, Panchatikta Kshira Basti along with Kati Basti particularly on the Roland and Morris index, low back pain and disability questionnaire and clinical features of Katigrah with special reference to Lumbar Spondylosis. 2. To compare the effect of Erandamula Ghanavati, Panchatikta Kshira Basti along with Kati Basti with Erandamula Ghanavati annd Panchatikta Kshira Basti.

研究概览

简要总结

Lumbar spondylosis is the most common progressive disorder in the ageing lumbar spine. It results from the process of degeneration of the vertebral discs and facet joints of lumbar spine. In Ayurveda its feature resembles with that Katigrah. In Ayurvedic texts its management is done on the basis of Samanya Chikitsa of Vatavyadhi which contain Snehana, Svedana, Basti and oral drugs. In this study will be evaluate the efficacy of Erandamula Ghanavati orally along with Panchatikta Kshira Basti and Kati Basti. Amidst this background, the eyes tried are looking towards Ayurveda with great hope of getting relieved from the deadly agonizing pain.

Low back pain can be correlated with Katishula in Ayurved, meaning Shula at the particular site Kati, Kasheruka and Trik Asthi. The particular symptom Katishula may be found in different disease having varied etiology. Particularly while relating lumbar spondylosis, the main significant cause of Katishula is Asthi Dhatu Kshaya.

Vata Dosha as described by Sushruta is responsible for Ruja or Shula (Su.Su.17/12)[11]. Vata is not only related with Katishula for its dominant role played in the pathology of Shula, but also Vata has said to have inversely proportionate relationship with Asthi Dhatu as Ashrya-Ashryi relation (A.H.Su.11/27-28)[12].Asthi Dhatu Kshaya result in Vata Prakopa and vice versa. Bony degenerative changes may relate Asthi Dhatu Kshaya and thus cause of vitiation of Vayu.

Aim is to evaluate the efficacy of Erandmula Ghanavati along with Panchatikta Kshira Basti and Kati Basti.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

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

入选标准

  • 1.The Roland-Morris low back pain and disability questionnaire; if RDQ score>
  • Radiological changes, degenerative changes in Lumbar spine.
  • Patients having sign and symptoms of Katigrah according to classics.
  • Patient willing and able to participate in the study.
  • Chronic low back pain more than three month.

排除标准

  • History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
  • Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded.
  • Patient with co morbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis, tubercular arthritis.
  • Patient with any deformity of hip or back altering the gait and posture of the patient, ankylosing spondylitis, spinal inflammatory disorders.
  • Patient with uncontrolled hypertension (?160/100mm of Hg) and uncontrolled diabetes (Blood sugar level fasting >125mg/dl and post lunch >200mg/dl) will be ruled out.
  • Patient with evidence of malignancy.
  • Patient on prolonged (?6weeks) medication with corticosteroids, non-steroidal anti-inflammatory drug, antidepressants, anti-cholinergic etc.
  • or any drugs that may influence on the outcome of the study.
  • Patient who have a past history of any other systemic disorders will be excluded in doubtful cases.
  • Pregnant / lactating women.
  • Patients who had participated in any other clinical trial since last six months.

结局指标

主要结局

1. Evaluate the effect of Erandamula Ghanavati, Panchatikta Kshira Basti along with Kati Basti particularly on the Roland and Morris index, low back pain and disability questionnaire and clinical features of Katigrah with special reference to Lumbar Spondylosis. 2. To compare the effect of Erandamula Ghanavati, Panchatikta Kshira Basti along with Kati Basti with Erandamula Ghanavati annd Panchatikta Kshira Basti.

时间窗: 1)Before start of treatment i.e.day zero 2)Duration of Treatment: Erandamula Ghanavati(30 days, Panchatikta Kshira Basti(15 days) Kati Basti(15 days) Effect of all above will be assessed on 16 th day. This will be second assessment. 3)Effect of all above will be assessed on 31rst day. this will be third assessment and will be termed as after treatment.

次要结局

  • 1. To study literature of Katigrah from texts.(2. To study lumbar spondylosis from modern point of view.)

研究者

发起方
Government Ayurved College Nagpur
申办方类型
Other [Government Ayurved College Nagpur]

研究点 (1)

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