A comparative clinical study to evaluate the effect of Chaturbhadra kalpa basti krama and Kalabasti krama in the management of Katigraha with special reference 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
- 62
- 试验地点
- 1
- 主要终点
- Improvement in subjective and objective criteria like VAS scale, lumbar flexion measurement, lumbar extension measurement, SLRT
研究概览
简要总结
Title of Study
Comparative Clinical Study to evaluate the effect of Chaturbhadra Kalpa Basti Kram and Kala Basti Kram in the management of Katigraha with special reference to Lumbar Spondylosis.
Background
Katigraha is a condition of low back pain caused by vitiated Vata dosha.
Lumbar Spondylosis is its modern equivalent—characterized by degeneration of lumbar spine with pain and stiffness.
Basti karma (medicated enema) is the primary treatment for Vata disorders in Ayurveda.
Objective
To compare the effectiveness of Chaturbhadra Kalpa Basti (12-day Anuvasan-dominant schedule) vs. Kala Basti (15-day classical schedule of alternating Anuvasan and Niruha basti)
in reducing signs and symptoms of Katigraha w.s.r. Lumbar Spondylosis.
Methods
Study Type: Comparative Clinical Trial
Sample Size: 62 patients (31 in each group)
Drugs Used:
Shatipushkaradi Tail (Anuvasan Basti)
Shatipushkaradi Kwath (Niruha Basti)
Assessment:
Subjective: Pain scale (VAS), Coin test
Objective: Lumbar flexion/extension, SLRT (Straight Leg Raise Test)
Inclusion Criteria
Age 30–70 years
Diagnosed lumbar spondylosis (X-ray)
Classical signs of Katigraha (pain, stiffness)
Exclusion
Fractures, TB spine, RA, pregnancy, other joint deformities
Basti Protocols-
Chaturbhadra Kalpa Basti Group A
4 Anuvasan - 4 Niruha - 4 Anuvasan over 12 days
Kala Basti Group B
Standard kala basti kram for 15 days
Results Expected -
Chaturbhadra Kalpa Basti is hypothesized to be more effective due to its bruhana (nourishing) nature, especially for chronic degenerative Vata conditions like katigraha.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient having classical sign and symptoms of katigraha such as pain (shool) and stiffness (stambha).
- •2.Indications of Niruh and Anuvasan basti.
- •3.Patients fulfilling the selection criteria and between the age of 30 to 70 years.
- •4.Degenerative changes evident on X-ray LS spine.
排除标准
- •1.Fracture of lumbar spine.
- •2.Patient who not fit for basti (Bleeding piles, Rectal prolapse) 3.Children and Pregnant women, lactating mother and during menstrual cycle 4.Patients with other joint deformities or diseases such as TB of spine, spinal abnormality, congenital scoliosis.
- •5.Patients with rheumatoid arthritis will be excluded from the study.
- •6.Patients with immunocompromised disease, psychiatric diseases.
- •7.Patients taking oral pain killers, NSAID’s or Ayurvedic drug for pain and patients undergoing any local karma like lepa, upnah, agnikarma etc.
结局指标
主要结局
Improvement in subjective and objective criteria like VAS scale, lumbar flexion measurement, lumbar extension measurement, SLRT
时间窗: 4-5 Weeks
次要结局
- Improvement in stiffness(4-5 weeks)
研究者
Dr Amruta Vasant Pednekar
R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI