Comparative study of Viddhakarma and Agnikarma in the management of Avabahuk W.S.R.to Frozen shoulder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparative study of Viddhakarma and Agnikarma in the management of Avabahuk W.S.R.to Frozen shoulder
研究概览
简要总结
Title: Comparative study of Viddhakarma and Agnikarma in the
management of Avabahuk W.S.R. to Frozen shoulder.
Null Hypothesis (H0) :- Viddhakarma not significantly effective in the management of Avabahuk than Agnikarma.
Alternative Hypothesis(H1) :- Viddhakarma significantly effective in management of Avabahuk than Agnikarma.
Study design:- Open Randomized Controlled Clinical Trial.
Inclusive Criteria:
- Diagnosed cases of Avabahuk with symptoms like shoulder
joint pain, restricted movements of shoulder, tenderness.
-
Age group between 18-65 years.
-
Selection shall be irrespective of sex, religion, socio-
economic status.
Exclusive Criteria:
- Diabetic Mellitus (>200 mg/dl), HTN (>140/100 mmHg),
Malignancy, HIV, HBsAG
2.Cardiac diseases
3.Anemia
4.Pregnancy
5.Bleeding disorders
6.Pitta Prakruti
7.Fracture of shoulder joint
Withdrawal Criteria:
-
Patients who request to withdraw
-
Developing diseases mentioned in the exclusion criteria
after enrollment.
- Out-migrating or temporarily going out, missing the
scheduled of procedure
-
During course of clinical study if any serious complications occurs which requires urgent treatment.
-
Symptomatic relief.
Note: Patients discontinuing the treatment will be replaced by
patients fulfilling the criteria of inclusion.
Sample Size:- Total 100 ( 50 for each group)
Patients coming in IPD and OPD of Shalyatantra department of research institute hospital and working hospital, with complaint of Avabahuk.
Group A - Trial group - Patients will be treated by Viddhakarma with disposable needle no. 26, 0.45mm in breadth, 13mm in length.
Group B - Control group - Patients will be treated by Agnikarma with Tamra Shalaka.
Study Duration - 18 Months
Duration of Treatment - 28 Days
Application of therapy on 0th, 7th, 14th and 21st day.
Follow up on 7th, 14th, 21st and 28th day.
Assessment on each follow up 7th, 14th, 21st and 28th day.
Subjective Parameters:
-
Painful shoulder movements
-
Shoulder Stiffness
-
Tenderness
-
Tingling Numbness
Objective Parameters:
-
Pain measurement with Visual Analogous Scale
-
Goniometric Scale Readings to assess shoulder movements.
Result and inference will be drawn on the basis of readings obtained before and after treatment by using the appropriate statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of Avabahuk with symptoms like shoulder joint pain, restricted movements of shoulder and tenderness at shoulderjoint.
排除标准
- •History of Neurogenic Shock or trauma or sight of blood 32
- •Skin infection at the place of puncture
- •History of injury, fracture to upper limb
- •Any type of comorbidity like diabetes, hypertension etc.
- •Patient on anticoagulant medications
- •Pregnant Women.
结局指标
主要结局
Comparative study of Viddhakarma and Agnikarma in the management of Avabahuk W.S.R.to Frozen shoulder
时间窗: 28 days | Application of therapy on 0th, 7th, 14th and 21st day. | Follow up on 7th, 14th, 21st and 28th day.
次要结局
- 1. To study in detail about Sandhigata Vata affecting Amsa Sandhi from Ayurvedic Texts(2. To study in detail about Frozen Shoulder.)
研究者
Dr Prathamesh Pramod Shetye
Yashwant Ayurvedic College PG Training and Research Centre, Kodoli.