A COMPARATIVE STUDY OF PARIJATA (Nyctanthes arbor-tristis Linn.) AND SHINSHAPA (Dalbergia Sissoo Roxb.) W.S.R. TO GRIDHRASI ( SCIATICA)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in Subjective Criteria –
研究概览
简要总结
Aim of the Study: To provide a safe and simple herbal drug for patients with Gridhrasi (Sciatica) and to evaluate the comparative efficacy of the herbal drugs Parijata (Nyctanthes arbor-tristis) and Shinshapa (Dalbergia sissoo).
Participants: Forty participants fulfilling the inclusion criteria will be recruited from the Outpatient Department (OPD) of the Department of Kayachikitsa at Pt. Khushilal Sharma Govt. (Auto.) Ayurveda College and Institute Bhopal. The study protocol will be approved by the Institutional Ethics Committee, and informed consent will be obtained from all participants.
Study Groups: The 40 participants will be randomly divided into two groups of 20 each.
* Group A (Parijata Group): Participants in this group will receive the herbal drug Parijata.
* Group B (Shinshapa Group): Participants in this group will receive the herbal drug Shinshapa.
Assessment Criteria: Efficacy will be assessed by comparing the following subjective and objective parameters before and after the treatment period.
I. Subjective Criteria:
* Ruk (Pain)
* Stambh (Stiffness)
* Spandana (Pulsation)
* Toda (Pricking Pain)
II. Objective Criteria (CCRAS):
* Straight Leg Raising Test: The angle of elevation will be measured in degrees.
* Ankle Jerk: Assessed for presence and intensity.
* Knee Jerk: Assessed for presence and intensity.
* Plantar Reflex: Assessed for presence and intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 21 Years to 60 Years.
- •Duration of illness upto 2 years.
- •Radiating Pain Starting from the gluteal region towards the foot (especially big toe).
- •Non involvement of urinary bladder and rectum.
- •Sever pain on squatting.
- •Patients fulfilling the diagnostic criteria.
- •7.Positive straight leg raising test.
- •8.Patients willing to sign the consent for participation in study.
排除标准
- •Age below 21 Years above 60 Years.
- •Patients having spinal tomour, TB, malignant disease of the pelvis, fracture of spine, congenital or acquired skeletal deformity.
- •Duration of disease more than 2 years.
- •Recent traumatic condition of spine leading to paralysis.
- •5.Pregnant and lactating women.
结局指标
主要结局
Improvement in Subjective Criteria –
时间窗: 30 days
1. Ruk (Pain)
时间窗: 30 days
2. Stambh (Stiffness)
时间窗: 30 days
3. Spandana (Pulsation)
时间窗: 30 days
4. Toda (Pricking Pain)
时间窗: 30 days
次要结局
未报告次要终点
研究者
Dr Pallavi kodle
Pt. Khushilal Sharma Ayu. College Bhopal M.P.