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临床试验/CTRI/2022/04/041669
CTRI/2022/04/041669尚未招募2 期

"Study The Efficacy Of Shunthibaladwaya Kashaya In The Management Of Janusandhigata Vata W.S.R To Knee Osteoarthritis."

Dr Shalini Negi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月18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
50
试验地点
1
主要终点
subjective assessement i.e Sandhishool,shoth,stambh,vatapurnadritisparsh

研究概览

简要总结

TITLE OF DISSERTATION

“STUDY THE EFFICACY OF SHUNTHIBALADWAYA KASHAYA IN THE MANAGEMENT OF JANU SANDHIGATA VATA W.S.R TO KNEEOSTEOARTHRITISâ€

AIM AND OBJECTIVES

AIM:

*     Tostudy the efficacy of ShunthibaladwayaKashaya in the management of JanuSandhigata Vata W.S.R to knee osteoarthritis.

OBJECTIVES:

*     Tostudy the Janu Sandhigata Vatain Ayurvedic and modern aspectsin detail.

*     Toevaluate the efficacy of ShunthibaladwayaKashaya in the management of JanuSandhigata Vata.

RESEARCHQUESTION

*     PrimaryResearch Question: Is Shunthibaladwaya Kashaya effective inthe management of Sandhigata Vata.?

 *     SecondaryResearch Question: Is Shunthibaladwaya Kashaya safe in themanagement of Sandhigata Vata.?

HYPOTHESIS

Null Hypothesis (H0):

*     Shunthibaladwaya Kashaya is not effective in themanagement ofJanu Sandhigata Vata.

 AlternateHypothesis (H1):

*     Shunthibaladwaya Kashaya is effective in themanagement ofJanu Sandhigata Vata.

DI  DIAGNOSTIC CRITERIA

Janusandhishool(paininkneejoint),shoth(swelling),stambha(stiffness),vaatpurnadrutisparsh(crepitus),restrictedmovement of knee joint.

data collection relevant toobjectives:

Patient: A detailed Case recordform including all the classical sign and symptoms of Janu Sandhigata Vata will beprepared. Data about basic demography like age, sex, occupation, diet etc. willbe collected & data about subjective criteria will be completed afterclinical examination of the patients

SOP OF SHUTHIBALADWAYA KASHAYA-

Raw materials of Shunthi,Bala,and Atibala will be purchase from local Ayurveda market and will beauthenticated and standardize in GMP certified center.

Sunthibaladwaya kashaya willbe prepared as per reference of sharangdharsanhita, madhayam khand ,similarlywe will be taking 5 gm of each ingrediants(i.e 15 gm of bharad or churna)&16 parts of water(240 ml) which will be reduced to 1/8 of liquid(30 ml)aftersimmering or cooking on a low flame.

DOSE- 30 ml BD after food

Anupan- warm water

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.patient having 30 to 70 years of either sex will be selected for study 2.clinical sign and symptoms of diagnosed patient of janu sandhigata vata will be selected i.e janusandhishool (pain in knee joint), shoth(swelling),stambha(swelling),vaatpurnadruti(crepitation) sparsh,restricted movement of knee joint.

排除标准

  • patient less than 30 years and more than 70 years
  • gouty arthritis
  • Rheumatoid arthritis
  • previous surgery on knee joint/traumatic joint injuries 5.heart disease/renal disease 6.hypertensive 7.pott,s spine/infection 8.pregnant and lactating mother.

结局指标

主要结局

subjective assessement i.e Sandhishool,shoth,stambh,vatapurnadritisparsh

时间窗: Day1,Day15,Day30,Day45,Day60

objective criteria i.e. range of motion ,Radiological assessement

时间窗: Day1,Day15,Day30,Day45,Day60

次要结局

未报告次要终点

研究者

发起方
Dr Shalini Negi
申办方类型
Other [self]

研究点 (1)

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