跳至主要内容
临床试验/CTRI/2024/09/073318
CTRI/2024/09/073318招募中不适用

A Clinical study on the role of Jalukavasecana followed by Kalavasti with Yastyahvadi niruha AND Balaguducyadi Taila anuvasana in the management of Gambhira Vatarakta with special reference to Avascular necrosis of the femoral head.

S.V. Ayurvedic College and Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
To evaluate the efficacy of jalūkāvasecana followed by kālavasti in the management of gambhīra vātarakta (avascular necrosis of the femoral head) by using objective parameters - harris hip score, numeric pain rating scale and HOOS survey.

研究概览

简要总结

Vātarakta is one of the unique disorder where both vāta and rakta plays active role in the disease pathogenesis10. Ācharya Caraka mentions Vātarakta as raktaja vikāra in Vidhiśoṇitīya Adhyāya in sūtra sthāna (C.Su.24/12)7 and devoted an exclusive chapter to explain about the detailed aspects of Vātarakta in cikitsā sthāna (C.Ci.29)8. In Suśruta Saṃhitā, Vātarakta is described in Mahāvātavyādhi Adhyāya of cikitsā sthāna (Su.Ci.5/1-16)9.

 In VaÌ„tarakta, there is vitiation of vaÌ„ta and rakta where the excessively aggravated vaÌ„ta dosa is getting obstructed by aggravated rakta which further leads to the vitiation of raktadhaÌ„tu (C.Ci.29/10-11)10.

 AÌ„charya Caraka mentioned two types of VaÌ„tarakta i.e. UttaÌ„na and GambhiÌ„ra. In UttaÌ„na VaÌ„tarakta, twak and mamsa dhatu are going to be involved, where as in GambhiÌ„ra VaÌ„tarakta the remaining deep seated dhatus are involved (C.Ci.29/19)11.

 GambhiÌ„ra VaÌ„tarakta is a broader disease entity and avascular necrosis of the femoral head may be considered as one of its presenting form in modern perspective. That’s why in present study we are trying to compare GambhiÌ„ra VaÌ„tarakta with Avascular necrosis of the femoral head.

 Avascular Necrosis means necrosis of bone due to inadequate blood supply. It typically affects the epiphysis of long bones at weight-bearing joints. The most common sites for AVN are the femoral head, knee, talus, and humeral head. The most common cause is trauma and the non-traumatic causes includes excessive alcoholic intake as well as excessive consumption of systemic steroids12. In the present study avascular necrosis of the femoral head is considered as this is the commonest presenting form.

 The modern medical management of avascular necrosis of the femoral head depends on the severity of disease. Treatment outcomes correlate directly with the stages of disease. In early stages, management of avascular necrosis of the femoral head is done by bisphosphonates, non-steroidal anti-inflammatory drugs, extracorporeal shockwave therapy etc. In later stages management is done by surgical treatment that includes core decompression, femoral osteotomy, total hip arthroplasty etc12. As these treatment modalities are having a lot of intricacies in terms of safety profile and cost effectiveness there is a dire need of exploring safe and effective alternate therapy.

 In the present study, JaluÌ„kaÌ„vasecana and Vasti has been considered as the therapeutic interventions basing on the general line of treatment of VaÌ„tarakta (C.Ci.29/41)13, (C.Ci.29/35-37)14.

 By considering all the above-mentioned aspects of VaÌ„tarakta, JaluÌ„kaÌ„vasecana is selected as one of the therapeutic module in the present study which is the most unique and effective method of blood-letting indicated in the management of vaÌ„tarakta, if there is pain, burning sensation, pricking pain along with reddish discoloration of skin (C.Ci.29/35-37)14.

          In the spectrum of vasti, for niruÌ„ha vasti purpose, YasÌ£tÌ£yaÌ„hvaÌ„di NiruÌ„ha vasti is selected which has been mentioned as the best one for the management of VaÌ„tarakta (C.Si.3/46)15.

      For anuvaÌ„sana vasti purpose, BalaÌ„ GudÌ£uÌ„cyaÌ„di Taila is selected which is mentioned of having vaÌ„taraktahara property (Sahasrayoga-Taila Prakarana)16.

Thus, the present study is entitled as,

“A CLINICAL STUDY ON THE ROLE OF JALUÌ„KAÌ„VASECANA FOLLOWED BY KAÌ„LAVASTI WITH YASÌ£TÌ£YAÌ„HVAÌ„DI NIRUÌ„HA AND BALAÌ„ GUDÌ£UÌ„CHYAÌ„DI TAILA   ANUVAÌ„SANA IN THE MANAGEMENT OF GAMBHIÌ„RA VAÌ„TARAKTA WITH SPECIAL REFERENCE TO AVASCULAR NECROSIS OF THE FEMORAL HEAD”.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with signs and symptoms of GambhiÌ„ra VaÌ„tarakta.
  • Patients presenting with I,II, III stages of the modified Ficat and Arlet classification of Avascular Necrosis of the Femoral head.
  • Patients who are eligible for JaluÌ„kaÌ„vasecana and vasti.

排除标准

  • Patients below the age of 20 and above the age of 60 years.
  • Patients with uncontrolled diabetes, hypertension and other major systemic illness.
  • Patients with stage IV of the modified Ficat and Arlet classification of Avascular Necrosis of the Femoral head.
  • Patients who are not eligible for JaluÌ„kaÌ„vasecana and vasti.
  • Patients who are suffering from coagulopathies.

结局指标

主要结局

To evaluate the efficacy of jalūkāvasecana followed by kālavasti in the management of gambhīra vātarakta (avascular necrosis of the femoral head) by using objective parameters - harris hip score, numeric pain rating scale and HOOS survey.

时间窗: before treatment (0th day)and after completion of treatment (24th day)

次要结局

  • To evaluate the efficacy of jaluÌ„kaÌ„vasecana followed by kaÌ„lavasti in the management of gambhiÌ„ra vaÌ„tarakta (avascular necrosis of the femoral head) by using objective parameters.(follow up after one month(54th day))

研究者

发起方
S.V. Ayurvedic College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kuncha Akshitha

S.V. Ayurvedic College and Hospital

研究点 (1)

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