跳至主要内容
临床试验/CTRI/2019/05/019121
CTRI/2019/05/019121尚未招募不适用

Utility of individualized homoeopathic medicine in managing pain of adhesive capsulitis : A prospective open label observational clinical study

DG CCRH1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Primary endpoint

研究概览

简要总结

Adhesivecapsulitis, commonly referred to as frozen shoulder, is associated withsynovitis and capsular contracture of the shoulder joint and can be classifiedas either primary or secondary. In presentscenario homoeopathic medicines could be a valid alternative treatment to providea significant improvement in pain and stiffness along with significant benefiton overall well being of the patients. Unfortunately there isinsufficient evidence to make conclusion about the utility of individualisedhomoeopathic medicine in management of adhesivecapsulitis.

So a study is need to undertake toexplore the possible effects of individualized homoeopathic medicines inrelieving pain and stiffness, reduction in limitation, and disability inactivities of daily life in the patients suffering from adhesive capsulitis.

Theresearchers at CRU Siliguri proposed to undertake an open label observationalclinical study to evaluate the utility of individualized homoeopathy inmanagement of pain and stiffness in patients with adhesive capsulitis

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.Patients of both gender 2.Patients within age of 30-70 years 3.Patients presenting with clinical symptoms of adhesive capsulitis of one or both shoulder 4.Patients in the stage of acute/freezing/painful stage and adhesive/frozen stiffening phase of adhesive capsulitis 5.Patient willing to give informed consent.

排除标准

  • •1.Severe degeneration of shoulder joint with marked joint narrowing with recent shoulder surgery within last 6 months 2.Deformity of shoulder (>12o); evidence by imaging or other evidences and requiring surgical intervention 3.Self-reported joint disorders (e.g. inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prosthesis of the upper limbs) other than adhesive capsulitis 4.Cases with other systemic diseases and with any vital organ failure and any self-reported immune-compromised states 5.Patients unwilling to give informed consent.

结局指标

主要结局

Primary endpoint

时间窗: Primary endpoint | Pain VAS score at the end of 2 months treatment.

Pain VAS score at the end of 2 months treatment.

时间窗: Primary endpoint | Pain VAS score at the end of 2 months treatment.

次要结局

  • Secondary endpoint(•ORIDL and WHOQOL scale assessment after 2 months treatment.)

研究者

发起方
DG CCRH
申办方类型
Contract research organization

研究点 (1)

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