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临床试验/CTRI/2026/01/102575
CTRI/2026/01/102575尚未招募2/3 期

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.

Dr Sandeep Rajendra Girase1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年2月20日最近更新:
适应症
相关药物

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

发起方
Dr Sandeep Rajendra Girase
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sandeep Rajendra Girase

MES AYURVED MAHAVIDYALAYA

研究点 (1)

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