A clinical study to compare effectiveness of Nasya Karma and snehapan with swalapamasha taila along with Sthanik abhyanga and Adtiya paka guggulu (Orally) in cases of avabahuk(WSR to Frozen Shoulder)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- SUBJECTIVE CRITERIA
研究概览
简要总结
AIM & OBJECTIVES:
- To assess the effectiveness of trial drug in improving the condition of disease.
2.To assess the effectiveness of trial drug (Svalpmasha Tail & Adityapak Gugglu) in improving quality of life in patients of Avabahuka w.s.r Frozen Shoulder.
-
To compare the efficacy of Svalp Masha Tail when used Externally (Abhyanga) & Internally (Nasya & Snehpan) & sanshamana chikitsa by Adityapak Guggul for internal administration in patients of Avabahuka w.s.r Frozen Shoulder.
-
To observe clinical improvement/ prognosis/ recurrence of disease during the follow up period.
PLAN OF STUDY
Selection of cases:
For the purpose of clinical trial, the patient of Avabahuka w.s.r Frozen Shoulder will be selected from OPD and IPD of ‘State Ayurvedic College and Hospital, Lucknow’ and other hospitals who will fulfil the criteria of selection of patients irrespective of their sex, caste and religion. A careful history, physical examination and necessary investigations will be performed as per Performa prepared for the present trial.
INCLUSION CRITERIA: 1. Patient of the age group between 25-65 years will be selected. 2. Sex: Both male & female. 3. All socioeconomically persons. 4. Patient voluntarily willing to participate in the trial. Symptoms- According to Astang Hridaya Ni. 15/43
Type of study: Phase 2, Rational, Randomized parallel group study. • Period of study- Total duration of clinical trial is 3 months. Follow up period- During the treatment - 15 Days. After the treatment - 15 Days. Sample Size: Minimum 50 patients of Avabahuka w.s.r Frozen Shoulder from OPD and IPD of State Ayurvedic College and Hospital and referred cases of other hospital will be selected and randomly divided in two group i.e., group A and group B with approximately 10% drop out. Grouping: Group A- In this group patient will be treated with Nasya (internal use of Svalp Masha tail) & Sthanik Abhyanga along with Adityapak Gugglu orally for 15 Days. Group B- In this group patient will be treated Snehpan (internal use of Masha tail) & Sthanik Abhyanga along with Adityapak Gugglu (orally) for 15 Days.
PLAN OF TREATMENT
Group A: In this group of patients, Nasya (Marsha Nasya) will be given with Svalpmasha Tail in each nostril 6 Drops & Sthanik Abhyanga on shoulder region to neck region for 15 min. in Evening & Adityapak guggul orally 2-tab (each tab. 500 mg) B.D. with lukewarm water after taking meal.
Group B: In this group of patients, Snehpana of Svalpmasha Tailam (30 M.l., B.D. with milk) will be given & Sthanik Abhyanga on shoulder and neck region for 15 min. in Evening along with Adityapak guggul orally 2-tab (each tab. 500 mg) B.D. with lukewarm water after taking meal.
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
- 25.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient of the age group between 25-65 years will be selected.
- •Sex: Both male & female.
- •All socioeconomically persons.
- •Patient voluntarily willing to participate in the trial.
排除标准
- •Patients below age of 25 years and above 65 years of age.
- •Patients not fit for treatment.
- •Patients having injury to Shoulder Joint.
- •Diabetic Neuropathy.
- •Gouty & Rheumatoid arthritis.
- •Any other Systemic Disorder.
结局指标
主要结局
SUBJECTIVE CRITERIA
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
Essential Criteria
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
1. Bahu Shoola(Shoulder Pain)
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
Non-Essential criteria:
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
1. Stiffness of Shoulder.
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
2. Wasting of Shoulder
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
3. lack of the movement of Shoulder
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
4.Radiation of pain to back of head & arms
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
5. Sleep Disturbance
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
6. Paresthesia
时间窗: before trial,15days , 30days,45days,60days, | after one month of trial
次要结局
- OBJECTIVE CRITERIA
研究者
Dr Kamal Kishor
State Ayurvedic College and Hospital Lucknow
