A Pharmaco clinical Study To Evaluate The Efficacy Of Ashwagandha Ghrita (Withania somnifera Linn) and Bala Tail(Sida cordifolia Linn) in Janu Sandhivata wsr to Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. pain in joints
研究概览
简要总结
A OA patient experiences difficulty in persuing in day to day activity. therefore , i select this trial . this research evaluate the efficacy of ashwagandha ghrita & bala tail. this research is parallel group randomised clinical study of 60 patients.
group A (n=30)- the patients will be given ashwagandha ghria (6gm) twice a day with lukewarm water after meal.
group B(n=30)- the patients will be given bala tail for abhyang as local application(min 5 min) twice a day & ashwagandha ghrita(6gm) with lukewarm water twice a day after meal
duration of trail - 2 months
follow up - the follow up conducted during study period for once in 15 days. after completion of trial of 2 months , the follow up without drug after 15 days for one month.
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
- •1 Age group between 40 to 70 years 2 The patients with classical signs and symptoms of sandhivata given in various texts as well as the clinical features of disease of OA given in Modern medicine 3 Patient who gave the consent to participate in study.
排除标准
- •1 Age group less than 30 years and more than 70 years 2 Patients having past history or actively suffering from other inflammatory disease like RA Gout Septic Arthritis etc 3 Cases with severe deformities of joint and having major complications are excluded 4 Pregnant and lactating women 5 Patients having substantial abnormalities in Hematological Hepatic Metabolic function and systemic disorders like Diabetes and Hypertension 6 Avaranjanya Sandhivata.
结局指标
主要结局
1. pain in joints
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
2. crepitus
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
3. pain during extension and flexion
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
4. loss of motion and range
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
5. swelling in affected joint
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
6. morning stiffness(less than half an hour)
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
7. tenderness of joint
时间窗: - the follow up conducted during study period for once in 15 days. | After completion of trial of two month, the follow up without drug after 15th day
次要结局
- 1. CBC, ESR(2. Blood sugar (HbA1c/random/fasting/pp))
研究者
Rahul Kumar
State Ayurvedic College and Hospital, Lucknow