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临床试验/CTRI/2024/05/066993
CTRI/2024/05/066993招募中2/3 期

Comparative Clinical Trial To Evaluate The Efficacy Of Mashasaindhav Tail Nasya, Jambeera Pinda Sweda And Agnikarma In Avabahuka With Special Reference To Frozen Shoulder

Dr Vijay Prabhakar Shingade2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
To study the efficacy of Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma in Avabahuka

研究概览

简要总结

Avabahuka is one among the vatavyadhi which affects the normal functioning of the upper limbs, specially shoulder joint. Avabahuka can be correlated to frozen shoulder in modern science. Frozen shoulder is one of the most common disorder of the joint diseases. Research has shown a prevalence rate of frozen shoulder in the general population is 3% - 5% . Its peak incidence is between the ages of 40 - 60 yrs and is more common in women. Frozen shoulder clinically referred to as adhesive capsulitis, has been described as a condition of unknown etiology and characterized by gradually progressive, painful restriction of shoulder joint. The incidence of Frozen shoulder is increasing day by day. Due to Restricted movements of the affected joint, the life of the patient becomes miserable. Therefore there is a need of effective treatment to manage such a condition called frozen shoulder. The present study Randomized control Trials will be carried out with aim to evaluate the efficacy of Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma in Avabahuka with special reference to frozen shoulder. For present study patients fulfilling the diagnostic criteria of Frozen Shoulder, between the age group of 20 to 60 years with irrespective of gender, religion, socioeconomic status will be selected. Calculated Sample size is 120, it is divided into 3 groups. So, 40 patients will be taken for study in each group. Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma will be carried out in Group-A, Group-B and Group-C patients respectively. Trial drug for Group-A will be purchased from GMP certified pharmacy. This drug will be administered through nasal route with 4 ml quantity in each nostril for 14 days. Jambeera pinda sweda will be carried out in Group-B patients for 14 days. Agnikarma with suvarna shalaka  will be done in Group-C patients in 5 settings within 14 days. All SOP of Nasya karma, Jambeera pinda sweda and Agnikarma will be strictly followed during and after treatment. All the findings will be entered in case record form (CRF) and for better understanding tabulation and graphical presentation will be done. Observations will be drawn on before treatment (0th day), during treatment (7th day), after treatment (15th day) and at follow up (30th day). Result of study will be calculated statistically with appropriate statistical method. Result will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on the basis of statistical analyasis and will be unbiased.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Those who are fit for nasya Those who are fit for jambeera pinda sweda Those who are fit for agnikarma Patients will be selected irrespective of gender, occupation and habitat age group 20-60 years Patients presenting with classical clinical features of Avabahuka w.s.r. to Frozen Shoulder.

排除标准

  • Those who are not fit for nasya karma Those who are not fit for jambeera pinda sweda Those who are not fit for agnikarma Autoimmune disorders like SLE, RA etc.
  • Diabetic patients having diabetic neuropathy and increased glycemic index.
  • Dislocation and fracture of Shoulder joint.
  • Patients having thyroid disorders and tuberculosis.

结局指标

主要结局

To study the efficacy of Mashasaindhav tail nasya, Jambeera pinda sweda and Agnikarma in Avabahuka

时间窗: 14 Days

次要结局

  • To find out an effective, economic and easily available curative therapy for the treatment of Avabahuka.

研究者

发起方
Dr Vijay Prabhakar Shingade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vijay Prabhakar Shingade

Honorable Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta

研究点 (2)

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