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临床试验/CTRI/2025/07/091228
CTRI/2025/07/091228尚未招募不适用

A randomized comparative clinical trial to evaluate the efficacy of Bharangimool churnavati and Nirgundi ghanavati in the management of Gridhrasi.

PDEAs College of Ayurveda and Research centre Nigdi pradhikaran Pune1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1.To compare the efficacy Of Bharangimool churnavati and Nirgundi Ghanvati In relieving pain given for 21 days in management of Gridhrasi

研究概览

简要总结

  • In the present era, lifestyle trends are shifting away from healthy living, leading to an increase in various health issue,  One such condition is Gridhrasi, is a nanatmaj vata vyadhi Lower          back pain is an incredibly common musculoskeletal disorder that affects leg movement. Among patients experiencing this condition, approximately 40% suffer from radicular pain, which          can be classified as part of the sciatica syndrome.   Gridhrasi , which manifest as pain starting from the lower back (kati) and radiating down to the buttocks, thighs (uru) Knees ( Janu),          Calves and feet.
  • This pain pattern closely resembles sciatica, a debilitating condition where hip pain extends downs the leg and foot due to compression of sciatic nerve.
  • In modern medicine Gridhrasi correlated with sciatica
  • In modern medicine sciatica pain is managed by using anti- inflammatory, muscle relaxants, physiotherapy and even the surgical intervention but the chances of re-occurrence as well.
  • Ayurveda provides several effective options in the management of Gridhrasi.
  • Vataj  Gridhrasi – This type is characterized by stiffne    ( Stambha), Pricking pain (toda), twitching or trembling sensation( Spandana) and severe pain (Ruk) Orginating from the gluteal region (sphik   pradesha) the pain radiates down to various body parts, including the pelvis ( kati), back ( Prushta) thigh( Uru) Knee (janu), foot (paada)
  • Vata- Kaphaj Gridhrasi – in addition to the symptoms mentioned above this type presents with lethargy (tandra), Heaviness ( Gaurav) and loss of appetite ( Aruchi)

Study Rationale:

  • Although lots of work have been done in the management of Gridhrasi , still alternative medicines are required
  • Bharangimool churnavati is easily available and cost effective, In modern medicine painkillers give symptomatic relief only.
  • No other work has been done on the effect Bharangimool churnavati in the management of Gridhrasi, hence this formulation has been selected for the study .
  • In the treatment of  Gridhrasi  drug of choice should have Vatashamak, kaphashamak   Bharangi have both vatshamak and kaphashamak properties.
  • Bharangimool churnavati is mentioned in Gadanigrah having all properties may reverse the pathogenesis of Gridhrasi.
  • A rational of the study To compare the efficacy Of Bharangimool churnavati with Nirgundi Ghanvati for relieving the symptoms of Gridhrasi.

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

入选标准

  • 1.SLR test positive patient with the help of goniometer. 2.Patients in the age group of 25-60 years ,irrespective of religion,caste,gender and socioeconomic status. 3.Patient with classical signs of Gridhrasi jaanujanghapadam kramat and sakthikshepnigrahanat should be there 4.Radiating pain from kati pradesh (lower back) to paad ( foot )should be there . Radiating pain along the course and distribution of sciatic nerve 5.Associated symptoms are- Patients having two or more following symptoms.
  • katishool (lower back pain) spand (throbbing /pulsating) toda (pricking sensation ) aruchi ( anorexia) Gourav(heaviness) paadshool (leg pain ).

排除标准

  • 1.Patients having congenital anomalies with lumbosacral spine kyphosis, scoliosis, lordosis.
  • 2.Known case of Spondylolisthesis, sacroiliac arthritis.
  • 3.Known case of uncontrolled diabetes mellitus , deep vein thrombosis.
  • 4.Pregnant and lactating mothers.
  • 5.Patients with paraplegia of lower limb.
  • 7.Known case of Infective disorders –tuberculosis of Spine, osteomyelitis of spinal bone.
  • 8.Patients with deep wounds penetrating till sciatic nerve.
  • 10.Patients having allergy to any content of drugs.

结局指标

主要结局

1.To compare the efficacy Of Bharangimool churnavati and Nirgundi Ghanvati In relieving pain given for 21 days in management of Gridhrasi

时间窗: 21 Days with follow up on 8th,15th,22nd day

次要结局

  • 1.To compare the efficacy Of Bharangimool churnavati and Nirgundi Ghanvati for relieving other symptoms given for 21 days in management of Gridhrasi .(2.To observe and compare the adverse effects in two groups within 21 days)

研究者

发起方
PDEAs College of Ayurveda and Research centre Nigdi pradhikaran Pune
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rutuja Chandrakant Solunke

PDEAs college of ayurved and Research centre Nigdi pune 411044

研究点 (1)

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