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临床试验/CTRI/2024/05/067894
CTRI/2024/05/067894尚未招募3 期

To Evaluate the Efficacy of Add on Treatment of Oral Drug Formulation with Agnikarma in the Management of Jaanu Sandhigata Vata W.S.R. to Osteoarthritis of Knee Joint - A Randomized Controlled Trial.

CCRAS, PG - STAR1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月12日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Pain, assessed by VAS

研究概览

简要总结

Vitiated vata get settled in sandi Pradesh and aging Dhatus undergo Kshaya (degeneration), thus leading to Sandhivata 1.

Sandhigatavata  is  a  madhyamamargagataroga  and  it  happens  due  to  the  lodging  of  vayu  in sandhi   pradesha, formation   of   oedema   along withthere  is  difficulty  in flexion  and  extension  of  the joints. It is the most common articular disorder which begins asymptomatically in the 2nd and 3rd decades25% females and 16% males have symptomatic OA. Till the age of 55, it occurs equally in both sexes; after 55,the incidence is higher in women2.

Osteoarthritis is the most prevalent form of arthritis, and the societal burden is expected to increase with the increasing prevalence of obesity and the ageing of the community. There is no cure, and current therapeutic strategies are primarily aimed at reducing pain and improving joint function3.

For the management of OA, patients need to take analgesics and regular use of analgesics and steroids in old age may produce adverse effects4.Surgical therapy-like knee joint replacement and even after surgery patient has to continue some medicine for a long duration.

Ayurvedic approach of Agnikarma is to relieve the pain in OA, which is a nonpharmacological treatment and it has definite role in Jaanu Sandhigata Vata. .Sushruta has given direction for treatment of the Sandhigata Vata by Agnikarma5. Our clinical stratergy evolved from simple exploratory evalauations in herbal formulation of Guduchi(TinosporaCardifolia), Shunthi ( ZinziberOfficinalae ),Amalaki  ( EmbelicaOfficinalae ),Shallaki  ( Boswelia Serrata )

in powdered form .

To overcome such limitations of modern management, the present study is effective, safe, simple and economic treatment in the management of janusandigatavata. Hence “TO EVALUATE THE EFFICACY OF ADD ON TREATMENT OF ORAL DRUG FORMULATION WITH AGNIKARMA IN THE MANAGEMENT OF JAANU SANDHIGATA VATA W.S.R TO OSTEOARTHRITIS OF KNEE JOINT – A RANDOMIZED CONTROLLED TRIAL” is taken.

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of Jaanu Sandhigata vata (Osteoarthritisof knee joint) will be selected irrespective of gender, Socioeconomic status, Religion and Occupation.
  • 2.Jaanu Sandhigata Vata (Osteoarthritis of knee joint- Unilateral or bilateral).
  • Kellgren and Lawrence Classification System of Osteoarthritis (Grade 0,1,2,3).

排除标准

  • The patients of infective, neoplastic and Traumatic injuries of knee joint.
  • Patients who have received intra articular corticosteroids,Post surgical and Obese individuals.
  • Patients suffering from Hypertension, Diabetes Mellitus, Rheumatoid Arthritis, Systemic Lupus Erythmatous and Other Systemic disorders.
  • Pregnant and Lactating women.
  • Patients who are contra indicated for Agnikarma.

结局指标

主要结局

Pain, assessed by VAS

时间窗: 0, 7th, 14th, 21st day

次要结局

  • • Tenderness(• Swelling)

研究者

发起方
CCRAS, PG - STAR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Asha H Ballari

SVM Ayurvedic Medical College, ILKAL

研究点 (1)

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