Randomised controlled clinical trial to evaluate the add on effect of asthapad rajat shalaka agnikarma in management of katigat vata w.s.r. to lumbar spondylosis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Ashtapad Rajat Shalaka Agnikarma in reducing pain,
研究概览
简要总结
Title - RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE ADD ON
EFFECT OF ASHTAPAD RAJAT SHALAKA AGNIKARMA IN MANAGEMENT OF
KATIGAT VATA W.S.R.TO LUMBAR SPONDYLOSIS.
Null hypothesis [H0] - Ashtapad rajat shalaka agnikarma is not significantly effective in katigata vata
with special reference to lumbar spondylosis .
Alternate hypothesis [H1] - Ashtapad rajat shalaka agnikarma is significantly effective in katigata vata
with special reference to lumbar spondylosis.
Study design - Randomized controled clinical trial
Inclusion criteria -
Clinical features of Katigata Vata / lumbar spondylosis confirmed by Xray
Patients of either sex between 30 to 60 years.
Willing & able to participate and complete the study.
Selection will be irrespective of gender, religion and other socioeconomic status.
Exclusive criteria-
History of spinal surgery, fractures, malignancy, or systemic illness
Pregnant and lactating women
Tuberculosis of spine
Contraindications for Agnikarma (skin disorders, bleeding disorders,
uncontrolled diabetes, etc.)
Sample size- 70 (35 for each group)
Sample population -
Patients coming to OPD, IPD parent ayurveda rugnalaya and camps in
the periphery of parent research center and hospital with Katigata vata(Lumbar spondylosis)
Group A- Yograj guggul vati + Dashmularistha +Ashtapad Rajat Shalaka agnikarma
Group B- Yograj guggul vati + Dashmularistha
Total duration of therapy is 10 days. The mode of drug administration will be oral route and local agnikarma therapy
Follow up - Follow up will be on 7th ,10th day
Result - Result will be drawn as per assessment criteria and statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Clinical features of Katigata Vata / lumbar spondylosis confirmed by Xray Patients of either sex between 30 to 60 years.
- •Willing & able to participate and complete the study.
- •Selection will be irrespective of gender, religion and other socioeconomic status.
排除标准
- •History of spinal surgery, fractures, malignancy, or systemic illness Pregnant and lactating women Tuberculosis of spine Contraindications for Agnikarma (skin disorders, bleeding disorders, uncontrolled diabetes, etc.).
结局指标
主要结局
To assess the efficacy of Ashtapad Rajat Shalaka Agnikarma in reducing pain,
时间窗: 10 days study with follow up on 7th & 10th day
stiffness, and improving functional status in Katigata Vata with special
时间窗: 10 days study with follow up on 7th & 10th day
reference to lumbar spondylosis.
时间窗: 10 days study with follow up on 7th & 10th day
次要结局
- Improvement in stiffness of the lower back.(Improvement in range of movements of the lumbar spine.)
研究者
Dr Sandeep Rajendra Girase
MES AYURVED MAHAVIDYALAYA
