跳至主要内容
临床试验/CTRI/2024/05/067621
CTRI/2024/05/067621尚未招募2 期

EFFECT OF INDIVIDUALISED HOMOEOPATHIC TREATMENT IN 50 MILLESIMAL SCALE ON FUNCTIONAL OUTCOME OF ADHESIVE CAPSULITIS-AN OPEN LABEL PROSPECTIVE STUDY.

National institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
ASES SCORE (Assessing pain in shoulder))

研究概览

简要总结

Adhesive Capsulitis of Shoulder characterised by pain and majorly affecting the movements of the joint nearly complete loss of passive and active external rotation of the shoulder. Commonly seen in manual  workers with prevalance rate of 2-5% in general population. In prospective study of 41 patients with 5 to 10 years followup found only 39% of patients had full recovery. Only few studies had been happened in the past on the effectiveness of Homoeopathic medicine in Adhesive Capsulitis and no study was done under 50 millesimal scale of Homoeopathic medicines in treating adhesive capsulitis. In Adhesive capsulitis severe pain and restricted movements are present for long terrm, so Its necessary to observe the effectiveness of 50Millesimal scale on this condition. As  in this scale medicines can be repeated regularly with no Aggravations. Thus the study has been taken to see whether there is significant change in ASES score for Adhesive cpasulitis using individualised homoeopathic medicine in 50 millesimal scale.

The study will be carried out at National institute of Homoeopathy. The sources of the samples will be the patients attending out patient department and Indoor patient department of the hospital. One year study with 3 months followup of each and every case with sample size of 40 patients are considered for a study of Non randomised, open label, single arm, prospective clinical study. Proper case taking of all enrolled patients will be done as per protocol and guidelines in the Organon of medicine 5th and 6th edition. Individualised Homoeopathic medicines will be prescibed in 50 millesimal potency in suitable doses. Each case will be assessed montly to followup the remedy reaction and ASES score quessionaire will be taken from Patients at the base line and after 3 months of treatment. ASES score is 100 point scale that evaluates 2 dimesnions of shoulder function that is both Pain and Performance of activities of daily living.The score obtained by patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. Theresult will be publised in scientific journals.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient with clinically diagnosed case of Adesive capsulitis who are willing to give consent for study.

排除标准

  • Cases suffering from uncontrolled systemic illness or life threatening disease.
  • Pregnant women and lactating Mothers.
  • Patient who are taking Other mode of Treatment for the same.
  • Simultaneous participation in any other clinical trial.
  • Patient under substance abuse or dependence.
  • Diagnosed cases of unstable mental or psychiatric illness.

结局指标

主要结局

ASES SCORE (Assessing pain in shoulder))

时间窗: baseline and 3 months)

次要结局

  • ASES score ( Assesing Quality of life activities )(baseline and at 3 months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Savitha Sharma

National institute of Homoeopthy

研究点 (1)

Loading locations...

相似试验