A Randomized Controlled Clinical Trial To Evaluate Sandhaneeya Effect of Rasonadiyoga In The Management Of Bahirprakoshtasthi Bhagna w.s.r To Colles Fracture.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the sandhaneeya effect of Rasonadiyoga in the
研究概览
简要总结
Title-RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE SANDHANEEYA EFFECT OF RASONADIYOGA IN THE MANAGEMENT OF BAHIRPRAKOSHTASTHI BHAGNA W.S.R TO COLLE’S FRACTURE.
Null Hypothesis (H0) : Rasonadiyoga is not effective in the management of Bahirprakoshasthi bhagna w.s.r. Colle’s fracture.
Alternative Hypothesis (H1) : Rasonadiyoga is effective in the management of Bahirprakoshasthi bhagna w.s.r to Colle’s fracture.
Study design– Randomized Controlled Clinical Trial
(1)Inclusion criteria-
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Patients in the age group 18-60 years.
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Patients of either sex.
-
Patient who are willing for trial and ready to give informedconsent.
4.Patients having Colle’s fracture type 1 (Transverse fracture of distal radial metaphysis) and type 2 (type 1 + ulnar styloid fracture) [FRYKMAN CLASSIFICATION] which can be reduced by closed reduction method with or without general anaesthesia.
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Fractures of styloid process of ulna.
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Cracked, broken and displaced colle’s fracture.
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Patients requiring external fixation and k- wiring.
(2) Exclusion criteria-
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Patients above the age of 60 years and below the age of 18 years.
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Patients having uncontrolled diabetes and hypertension, SERO positive, tuberculosis, Cardiac or systemic disorders.
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Patients with history of ischemic heart disease, metastatic tumour, injury to the blood vessels and nerves.
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Patient is not willing to undergo trials or refused to give informed consent.
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Fractures other than colle’s fracture.
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Open or compound fractures.
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Colle’s fracture having significant angulation and deformity.
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Patients suggestive of Osteomyelitis and other bone diseases
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Radio-ulnar Subluxation.
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Fractures requiring open reduction and internal fixation.
Sample size- total 60 (30 for each group)
Patients coming to OPD, IPD and patients of Orthopaedician attach to our hospital with Bahirprakoshasthi bhagna ( Colle’s fracture ).
Simple randomized sampling (Lottery method)
Group A - Rasonadiyoga
Group B - Syrup Calcium + vitamin D3
Total duration of drug administration is 6 weeks. The mode of drug administration will be by oral route.
Follow up- Follow up will be on 14th, 28th, 42nd day.
Result- Result will be drawn as per assessment criteria and statistical analysis.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group 18-60 years.
- •Patients of either sex.
- •Patient who are willing for trial and ready to give informed consent.
- •4.Patients having Colle’s fracture type 1 (Transverse fracture of distal radial metaphysis) and type 2 (type 1 + ulnar styloid fracture) [FRYKMAN CLASSIFICATION] which can be reduced by closed reduction method with or without general anaesthesia.
- •Cracked, broken and displaced colle’s fracture.
- •Patients requiring external fixation and k- wiring.
排除标准
- •1.Patients above the age of 60 years and below the age of 18 years.
- •Patients having uncontrolled diabetes and hypertension, SERO positive, tuberculosis, Cardiac or systemic disorders.
- •Patients with history of ischemic heart disease, metastatic tumour, injury to the blood vessels and nerves.
- •Patient is not willing to undergo trials or refused to give informed consent.
- •Fractures other than colle’s fracture.
- •Open or compound fractures.
- •Colle’s fracture having significant angulation and deformity.
- •Patients suggestive of Osteomyelitis and other bone diseases
- •Radio-ulnar Subluxation.
- •Fractures requiring open reduction and internal fixation.
结局指标
主要结局
To evaluate the sandhaneeya effect of Rasonadiyoga in the
时间窗: 6 weeks study with follow up on 14th,28th, 42nd day
management of Bahirprakoshtasthi bhagna w.s.r to Colle’sÂ
时间窗: 6 weeks study with follow up on 14th,28th, 42nd day
fracture.
时间窗: 6 weeks study with follow up on 14th,28th, 42nd day
次要结局
- 1. To provide cheap, economic and side effect free drug for the(promotion of bone healing.)
研究者
Dr Mayuri Vijay Unde
MES Ayurved Mahavidyalaya