跳至主要内容
临床试验/CTRI/2024/11/076351
CTRI/2024/11/076351尚未招募2 期

A Randomised Comparative Clinical Study to Evaluate the Efficacy of Paribhadradi pralepa and Paribhadradi ointment in the management of Janu Sandhigata Vata ( Knee Osteoarthritis)

Not sponsored1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
The expected outcome of the study would ideally demonstrate the efficacy of both

研究概览

简要总结

In this study, patients will be recruited from the Outpatient Department of Kaya Chikitsa  at M.C. DAV Hospital in Jalandhar. Selection will be based on specific inclusion and exclusion criteria. Prior to enrollment, routine investigations will be conducted to ensure eligibility for participation in the study.This study aims to compare the efficacy of Paribhadradi Pralepa and Paribhadradi Ointment in managing symptoms of knee osteoarthritis, focusing on pain relief, functional improvement, and quality of life. Knee osteoarthritis (Janu Sandhigata Vata) is a prevalent condition that causes pain and disability. Traditional Ayurvedic treatments,( Paribhadradi Pralepa and Paribhadradi Ointment )comparative efficacy requires systematic evaluation..Paribhadradi Pralepa & Paribhadradi Ointment will be applied on Knee joints only at night and keep it on until the following morning, approximately eight hours.The findings of proposed study will support the integration of Ayurvedic treatments in the management of osteoarthritis and warrant further investigation into long-term effects and mechanisms of action

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

  • Patients in the age group of 40 to 70 years of either sex.
  • Patients having signs and symptoms of Janusandhigata Vata of Shotha (edema), Vatapurnadriti Sparsha (on palpation revealed as air filled bag) and pain with Prasaran (extension) and Akunchan (flexion) movements.
  • Patients having chronicity of disease Janusandhigata Vata (KOA) for less than 5 years.
  • Patients willing to sign consent form for the clinical trial.
  • Kellgren Lawrence (Radiological scale) of e” ≥2 13.

排除标准

  • Patients below 40 years and above 70 years of age.
  • Patients of Rheumatoid arthritis, Ankylosing and traumatic arthritis.
  • Patients suffering from paralysis, muscular dystrophy, polio or bony deformities.
  • Patients having systemic conditions such as Tuberculosis, Brucellosis, Osteomyelitis, Gouty Arthritis, Psoriatic Arthritis and Systemic Lupus Erythematosus
  • Patients having neoplasm of spine and other complicated diseases like CCF, DM, Uncontrolled HTN, Unstable Angina, Recent MI etc.
  • Patients using anti-inflammatory medicines including Allopathic medicine and AYUSH medicines.

结局指标

主要结局

The expected outcome of the study would ideally demonstrate the efficacy of both

时间窗: 15 days

Paribhadradi Pralepa and Paribhadradi ointment in improving pain, functionality, and

时间窗: 15 days

quality of life in patients with knee osteoarthritis, while also ensuring their safety and

时间窗: 15 days

tolerability profile.

时间窗: 15 days

次要结局

  • Reduction in hospital visits after completion of trial(30 days)

研究者

发起方
Not sponsored
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Dr Chander Shekhar Sharma

Dayanand Ayurvedic College, Jalandhar city,Punjab

研究点 (1)

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