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临床试验/CTRI/2018/03/012346
CTRI/2018/03/012346已完成3 期

Assessment Of Vaitarana Basti And Rasna Guggulu In The Management Of Pain In Gridhrasi (Sciatica) A Randomized Controlled Clinico Experimental Study

IPGT and RA Gujarat Ayurved university Jamnagar1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年8月3日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Assessment will be done on the basis of special designed proforma

研究概览

简要总结

This study was a randomized, parallel group, activecontrolled trial comparing the safety and efficacy of Vaitarana Basti(16 days) and Rasna guggulu 1gms/day (30 days), Vaitarana basti(16 days) and Rasna guggulu 1 gms/day (30 days) in 101 patients withSciatica that was conducted in Panchakarma Hospital, IPGT&RA, GujaratAyurveda University, Jamnagar. The primary outcome measures were assessed onthe basis of relief found in the cardinal features of the disease. Pain by VisualAnalogue Scale, Stambha (stiffness), Suptata (numbness), Spandana(throbbing/pulsating), Aruchi (anorexia), Tandra (drowsiness), Gaurava(heaviness) muscle power and Straight Leg Raising are the criteria’s which was assessedaccording to their respective standard grading’s before treatment, aftertreatment and after follow up period of 4 weeks.

A total of 101 patients were enrolledfor the study and allotted to three groups by randomization sequence. From thissample 96 patients completed the study and 5 patients discontinued due topersonal reasons. The main findings of the study were: Vaitarana Basti is more effective in managing Vata Kaphatype of Gridhrasi while Rasna guggulu is better for Vatikatype of Gridhrasi. Upon the assessment on effect of therapies, combinedeffect of Vaitarana basti and Rasna guggulu provided best resultsin comparison to Vaitarana Basti and Rasna guggulu givenseparately. Vaitarana basti gave better results than Rasna gugguluin individual administration of medicines.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Diagnosed cases of Gridhrasi with symptoms like Ruja, Stambha, Suptata, Spandana, Tandra, Gaurava, Arochaka.
  • •Patients of age group between 20 and 65 years, belonging to both sex.
  • •Patients indicated for basti karma Willing to sign the consent for study participation.

排除标准

  • •Uncontrolled diabetes mellitus, hypertension, tuberculosis of spine and hip joint, malignancy of spine or other organs Fracture related to spine Cardiac diseases (ischemic heart disease, coronary artery disease, myocardial infarction etc.) Anemia (hemoglobin % <07.00 mg/dl) Pregnancy.
  • •Patients contraindicated for basti.

结局指标

主要结局

Assessment will be done on the basis of special designed proforma

时间窗: 7 days

次要结局

  • Assessment will be done on the basis of special designed proforma(60 days)

研究者

发起方
IPGT and RA Gujarat Ayurved university Jamnagar
申办方类型
Research institution and hospital

研究点 (1)

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