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临床试验/CTRI/2020/04/024613
CTRI/2020/04/024613已完成2 期

A comparative clinical effect of Agnikarma and Physiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. to Frozen Shoulder

Institute for post graduate teaching and research in ayurved1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月16日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Relief in signs and symptoms of Avabahuka(frozen shoulder)

研究概览

简要总结

The research study entitled “A comparative clinical effect of Agnikarma and Physiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. to Frozen Shoulder.†Was aimed to evaluate and compare the efficacy of Agnikarma and physiotherapyalongwith Dashmooladi Kwatha in themanagement of Avabahuka w.s.r. frozen shoulder. This trial was summarized in review of literature, including Ayurvedic literature and modern literature of Avabahuka (frozen shoulder) and literature of Agnikarma.

Drug review comprises classical narration of Dashmooladi Kwatha with Pharmacognostical and analytical study.

Clinical study stats the open labelled comparative clinical studyof 111 clinical cases of frozen shoulders divided into two groups according computer generated randomization chart. Total 168 cases were screened through out the study with shoulder joint pain, among which total 111 cases were frozen shoulder falling in the study criteria. 57 cases were excluded due to failure for enrollment in the study. Rest 111 cases were enrolled for the study, 11 cases were dropped out and 100 cases completed the course of treatment and follow up as mentioned in study In group A (n=55), frozen shoulder patients managed through 4 sittings of Samyaka Bindu Dagdha Agnikarma with red hot Panchadhatu shalaka at most tender point of affected shoulder in seven days interval and Dashmooladi kwatha 50 g orally at evening after meal advised for 28 days. In group B (n= 56), physiotherapy was advised two times a day for fifteen minutes in each session with Dashmooladi kwatha 50 g orally at evening after meal advised for 28 days. Among which 49 patients in group A while 51patients in group B completed the treatment and follow up as per protocol. 6 patients in group A and 5 patients in group B were dropped out from the study. All the cases were screened for essential haematology, urology, bio-chemical and radiological investigations prior their enrolment for the study.  The effect of the treatment was assessed on the basis of relief in Pain, stiffness, Muscle power, muscle wasting, sensory loss, disability of arm, shoulder and hand (DASH) Score where subjective criteria were assessed by VAS scale and gradation. Active ranges of movements (AROM), were considered as the objective parameters. The AROM namely flexion, extension, abduction, adduction, internal rotation & external rotations in abduction were recorded according to the actual values of goniometric readings. All the cases were followed up for 1 month. The observed results in the study were subjected to statistical calculation to derive final conclusion.

Discussion on study was made on demographic observations and clinical findings. Conclusion of clinical study suggest that both the groups treatment protocol have shown Highly significant effect in shoulder pain, stiffness, DASH Score, abduction, flexion, internal rotation, external rotation, ESR in managing the cases of frozen shoulder whereas Significant difference was observed in Extension through therapy in both the groups. Highly significant difference was observed in comparative effect of therapy in pain, stiffness, DASH score and internal rotation whereas significant difference was noted in abduction. Non-significant difference was observed in comparative effects of therapy in relieving restricted flexion, extension, external rotation, ESR. Finally, study concluded that Agnikarma with Dashmooladi kwatha have better effect to manage shoulder pain as well as to restore joint function as compare to physiotherapy with Dashmooladi kwatha in the management of Avabahuka (frozen shoulder). Thus, it declares that, alternative hypothesis is accepted and null hypothesis is rejected i.e., Agnikarma along with Dashmooladi Kwatha ismore effective thanphysiotherapy along with Dashmooladi Kwatha in the management of Avabahuka w.s.r. tofrozen shoulder.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • Patients suffering from Avabahuka (Pain and Stiffness in shoulder region or upper arm and Restricted range of motion of shoulder joint (ROM) 2)Patients with the age group 40-70 years irrespective of sex religion occupation socio-economic status etc will be included in the study 3) Patients with controlled diabetes mellitus (FBS: <140mg/dl, PPBS:<180mg/dl) 4)Patients fit for Agnikarma 5)Duration of frozen shoulder up to 2 years.

排除标准

  • Age below 40 years and above 70 years 2) Shoulder joint dislocation/ fracture 3) Patients of uncontrolled Diabetes mellitus(FBS: >140mg/dl, PPBS:>180mg/dl) 4) Other diseases like Paralysis, Parkinson’s disease, cardiac diseases, renal diseases and endocrine diseases, severe Anemia, and Malignancy, 5) Pregnant and lactating female 6) Patients contraindicated for Agnikarma as per classics 7)Rotator cuff injuries 8)Recent history of trauma in the affected shoulder.

结局指标

主要结局

Relief in signs and symptoms of Avabahuka(frozen shoulder)

时间窗: After 1 month of treatment

次要结局

  • improves quality of life of person(after 1 month)

研究者

发起方
Institute for post graduate teaching and research in ayurved
申办方类型
Research institution and hospital

研究点 (1)

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