A randomized comparative clinical study to evaluate the effect of Yogaraja Guggulu Rasayana and Lashuna Rasayana in Janu Bheda W.S.R to Osteoarthritis of the Knee joint.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment is done on 0th and 30th day
研究概览
简要总结
This is a randomizedcomparative clinical study to evaluate the effectiveness of group A- YogarajaGuggulu Rasayana which will be given for 30 days in the dosage of 6 tablets ODof 450mg after Koshta Shodhana of 1 day with Eranda Taila and Shunti Kashaya. GroupB- Lashuna Rasayana for 30 days in dosage of 12 capsules of 500mg OD with milkafter 1 day of Koshta Shodhana with Eranda Taila and Shunti Kashaya. The groupB subjects after 30 days of medicine will be given 20gm of Trivrut Lehya withmilk for 1 day, morning on empty stomach for Shodhana. There will be 15subjects in each group and selection will be based on permuted blockrandomization method. The study will be conducted in Sri DharmasthalaManjunatheshwara college of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi.The primary outcomes are WOMAC scale for Osteoarthritis, Pain Visual Analog Scale,range of motion and functional ability. Secondary outcome measures are gait, swelling,stiffness and tenderness. The assessment will be done on 0th day and 30th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All participants fulfilling the diagnostic criteria from the age of 30 to 70 years Participants willing to sign the informed consent form to participate in the research.
排除标准
- •Subjects suffering from illnesses like Rheumatoid Arthritis, Gouty Arthritis ,Systemic Lupus Erythematous, Fracture Any other metabolic and auto Immune joint pathologies Pregnant women and lactating women Patients unfit for Guggulu or Lashuna intake.
结局指标
主要结局
Assessment is done on 0th and 30th day
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
4)Functional ability
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
Time required to cover 30 meters in seconds
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
10 sit up time required
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
1)WOMAC index of Osteoarthritis
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
2)Pain Visual Analog Scale
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
3)Limitation of range of moments with the help of Goniometer
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
time taken to climb 10 steps
时间窗: Assessment will be done on the basis of Subjective and Objective criteria on 0 and 30th day
次要结局
- 1)Gait(2)Swelling)