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临床试验/CTRI/2024/03/064682
CTRI/2024/03/064682已完成3 期

Effect of sahachara taila anuvasan basti given on the same and alternate day of erandamuladi niruha basti under kala basti in the management of lumbar spondylosis (kati shoola)- An open labelled randomised comparative clinical trial.

Institute of Teaching and Research in Ayurveda Jamnagar 3610081 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Relief in pain

研究概览

简要总结

The title of research project isEFFECT OF SAHACHARA TAILA ANUVASANA BASTI GIVEN ON THE SAME AND ALTERNATE DAY OF ERANDAMULADI NIRUHA BASTI UNDER KALA BASTI IN THE MANAGEMENT OF LUMBAR SPONDYLOSIS (KATI SHOOLA)- AN OPEN LABELLED RANDOMISED COMPARATIVE CLINICAL TRIAL.I****ntroduction: There are two different protocols suggesting use of Anuvasana Basti, after use of Niruha Basti. Charakacharya and Dalhana mentions use of Anuvasana Basti on the same day of Niruha, to avoid Vata Dosha vitiation, and Chakrapani mentions next day Anuvasana Basti, which is followed majorly in practicality. Thus, the comparison of these two treatments is expected from this study. The disease considered here is lumbar spondylosis, which is degenerative in nature; and produces pain, stiffness and reduced ROM. Its prevalence is around 70% amongst all musculoskeletal pains. 

Aims and objectives: To assess and compare the efficacy of Sahachara Taila Anuvasana Basti administered on the same day andalternate dayof Erandamuladi Niruha Basti under Kala Bastiin the management of Lumbar spondylosis (Kati Shoola).

Materials & Methods: The study was initiated after ethical clearance from IEC and registration with CTRI. Total 30 patients enrolled in the study underwent randomization and 15 patients in each group were allotted. All the participants were administered KalaBasti, with Anuvasana by *Sahachara Taila-*120 ml, and Niruha by Erandamooladi Niruha Basti. In Group A, Anuvasana Basti was given on next day of Niruha, while in Group B, same day Anuvasana Basti was administered. The treatment was adopted for 16 days in Group A, and 10 days in Group B. Evaluation of efficacy in subjective and objective parameters, assessment of Basti pattern was carried out and statistical assessment was done.

Results and Discussion:Results: Both the groups showed highly significant result individually in all symptoms, while statistically significant results were observed. Clinically, Group B was better than Group A in relieving pain (VAS), ODI (Oswestry Disability Index) and ROM (Range of Motion). Group A showed better result clinically in stiffness. Duscussion: In Katishoola (lumbar spondylosis), Vata with Aama/Kapha Avarana is involved. Erandamooladi Niruha Basti, being Kaphahara and Vatanulomana, removes Avarana and clears Srotas. In ADAB, stronger Lekhana and Deepana actions relieve stiffness better. In SDAB, same-day Anuvasana Basti balances Vata through Snigdhata, improving pain (VAS), ODI, and ROM.

Follow up:Follow up was done after 15 days of treatment.

Adverse effects:This treatment have no any unwanted effects.

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

入选标准

  • Patients presenting with any of the signs and symptoms of Lumbar spondylosis (Kati shoola).
  • Degenerative changes on X-ray LS Spine- AP, Lateral view.
  • Patients who are indicated for Basti Karma.
  • Willing and able to participate in the study.

排除标准

  • Patients below 30 years and above 60 years of age.
  • Diagnosed patients of chronic diseases like, uncontrolled Diabetes mellitus, Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis, Lumbar spondylitis, Lumbar spondylolisthesis.
  • Patients having spinal tumor, malignant diseases of the pelvis, tuberculosis of vertebral bodies, Congenital Anomalies like Spina Bifida.
  • Patients having fracture/dislocation, underwent recent lumbar surgery or implanted instrumentation or prostheses.
  • Pregnant and lactating women.

结局指标

主要结局

Relief in pain

时间窗: 16 days for group A | 10 days for group B

次要结局

  • Radiological changes(16 days for group A)

研究者

发起方
Institute of Teaching and Research in Ayurveda Jamnagar 361008
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anil Kumar

ITRA Jamnagar

研究点 (1)

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