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临床试验/CTRI/2025/08/092446
CTRI/2025/08/092446尚未招募2/3 期

A randomized comparative clinical study to evaluate the effect of Hijama Mutaharrika with Roghan-e-babuna and Short- wave diathermy in the management of Waja’al- zahr (non-specific low back pain).

State unani medical college and hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
1. VAS

研究概览

简要总结

Low back pain is a prevalent issue worldwide affecting numerous individuals in modern times. In Unani system of medicine Waja occurs due to abrupt changes in the temperament of Su e mizaj Mukhtalif and Tafarruq e Ittesal. The newly developed abnormal temperament becomes hot or cold contrary to the original temperament and causes pain. Low back pain is a disease in which pain arises from internal and external muscles and ligaments surrounding the lumbar and lumbosacral region. It is a common disorder in urban and rural population, which is associated with substantial morbidity for about 80 percent of the general population not only in industrialized world but also in rural communities. Low back pain is divided into two categories: 1. Specific 2. non- specific. In specific low back pain the cause can be detected and In Non-specific low back pain there is no specific cause can be detected. The prevalence of LBP is also concerning in India affecting nearly 60 percent of the population at some point of their lives.The annual occurrence of the low back pain is estimated 5 percent per year, leading to prevalence ranging from 60 to 90 percent. This condition limits the functional ability, impacting occupational activities and imposing a significant socio-economic burden. In Allopathic system of medicine initial treatment of low back pain often involve the use of certain topical and systemic analgesics and anti-inflammatory drugs such as Acetaminophen, NSAIDS and steroid therapy. Though, they relieve pain and symptoms with high recurrence ratealong with causing certain adverse effects like hepatotoxicity, nephrotoxicity and gastrointestinaltoxicity. As there seems to be lack of permanent relief solution and need for alternative approaches that are both effective and safe. There are different kind of treatment in the Unani system of medicine which are more effective than Allopathic system of medicine. In Ilaj-Bit- Tadbeer various regimens such as- Hijama (cupping), Dalk(massage), Abzan(sitz bath) and Fasd(Venesection), Nutool (irrigation), riyazat (exercise) and taleeq(leeching ) etc. are more effective and devoid of any side effect.

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

入选标准

  • Patients willing to participate in the study and follow the instruction.
  • Age group 20 to 60 years.
  • Patients of both genders.
  • No radiation of low back pain in other region.
  • Clinically or radiologically diagnosed patients of waja’al-zahr.
  • ODI scoring: 10 percent to 60 percent (mild to severe)
  • No apparent spine deformity like Kyphosis, Scoliosis and Lordosis etc.
  • BMI more than 29kg/m2.

排除标准

  • Patient below age 20 years and above 60 years
  • H/O Tumor or malignancy
  • Pregnant and lactating women
  • Diabetic and Hypertensive patients
  • Patient of Rheumatoid Arthritis and Gout.
  • H/O Trauma or surgery of lumbosacral region
  • Patient on steroid therapy
  • Patients taking analgesic drug treatment in past one week.

结局指标

主要结局

1. VAS

时间窗: 7th,14th,21st,28th day

2. Oswestry low back pain questionnaire.

时间窗: 7th,14th,21st,28th day

次要结局

  • SF36

研究者

发起方
State unani medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mantasha Khan

State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)

研究点 (1)

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