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临床试验/CTRI/2024/07/070014
CTRI/2024/07/070014尚未招募2 期

An open label comparative study to evaluate the efficacy of Marma chikitsa and Agnikarma in the management of Avabahuka WSR to Frozen shoulder.

Dr Aswathy K1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年9月2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
110
试验地点
1
主要终点
1)Pain relief will be there.

研究概览

简要总结

This study is a randomized , open label comparative study to evaluate the efficacy of marma chikitsa and agnikarma in the management of avabahuka WSR to frozen shoulder. The primary outcomes are relief in pain and stiffness with increase range of movements and thereby patient leading a healthy life within a month. The secondary outcomes are the patient regains his day to day activities, functional progressions, reinforce confidence in future and motivation to keep moving shoulder and full body.

Study design - An open labeled randomized comparative clinical study.

The patients will be divided randomly into two groups by computer generated randomized method.

GROUP  A

Intervention - 50 patients of avabahuka will be treated with Agnikarma as well as Ashtavargam kashayam .

Instrument - Swarna shalaka.

Type - Bindu dahana visesha.

Position - At the most tender point of the shoulder joint.

Dose - 06 sittings in 15 days with regular intervals.

Follow up period - 15th day, 1st month, 3rd month.

GROUP B

Intervention - 50 patients of avabahuka will be treated with Marma chikitsa as well as Ashtavargam kashayam.

Site of the marma - Kakshadhara, Amsa, Amsaphalaka, Kurpara, Aani and Kshipra will be identified.

Method - Each marma will be stimulated by giving adequate digital pressure with thumb or finger for 15/16 times for one second. This procedure will be repeated thrice with resting 5 minute in between. Marma chikitsa will be given after the first assessment in a gap of 2 days.

Duration - 15 days.

Follow up - 15th day, 1st month, 3rd month.

SUBJECTIVE PARAMETERS

Pain in the shoulder region or upper arm(shoola).

Stiffness in the shoulder region or upper arm (stambha)

OBJECTIVE PARAMETERS

Restricted range of motion of shoulder joint(ROM) bahupraspanda haratvam such as adduction, abduction, flexion, extension, internal rotation, external rotation.

Range of movement calculated by adduction, abduction, flexion, extension, internal rotation, external rotation were recorded according to the actual values of goniometric readings.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patient fulfilling diagnostic criteria.
  • Patient irrespective of gender, religion, occupation,socioeconomic status etc will be included in the study.
  • Shoulder pain for at least 3 months and less than 12 months duration.
  • Patients with controlled diabetes mellitus and other systemic diseases such as hyperthyroidism and hypothyroidism.
  • Patients fit for agnikarma as per classics.

排除标准

  • Patients suffering from major trauma having dislocation or fracture of shoulder joint.
  • Patients of uncontrolled Diabetes mellitus.
  • Other diseases like Paralysis, Parkinson’s disease, cardiac diseases, renal diseases and endocrine diseases, severe Anemia, and Malignancy, tuberculosis 4)Pregnant and lactating female.
  • Patients contraindicated for Agnikarma as per classics.
  • Patients who need other emergency interventions like surgery.
  • Those patients who are regularly taking dependent on some specific medicines like anticoagulant, antiplatelet medicines, immunosuppressive medicines.
  • HIV and HbsAg reactive patients.

结局指标

主要结局

1)Pain relief will be there.

时间窗: 15 days

2)Stiffness will be reduced.

时间窗: 15 days

3) Range of movement will increase.

时间窗: 15 days

次要结局

  • 1) Regained day to day activities.(2) Functional progressions(power and endurance).)

研究者

发起方
Dr Aswathy K
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aswathy K

Madhya Pradesh Medical Science University, Jabalpur, Madhya Pradesh

研究点 (1)

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