EVALUATION OF THE EFFECT OF JAMBEERA PINDA SWEDA IN CERVICAL SPONDYLOSIS WRT CLINICAL SYMPTOMATOLOGY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 2. Change in the percentage score of Northwick Park Neck Pain Questionnaires.
研究概览
简要总结
Title of Study : EVALUATION OF THE EFFECT OF JAMBEERA PINDA SWEDA IN CERVICAL SPONDYLOSIS WRT CLINICAL SYMPTOMATOLOGY
Primary Objectivexml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" /
To evaluate the effect of JambeeraPinda Sweda in the management of Sign and symptoms of cervical spondylosis.
Secondary Objective
To observe the changes in the quality of life of the study participants by using SF-36 Questionnaire.
OUTCOMES
Primary outcome
· Relief in Signs & Symptoms (pain and associated complaints) of the disease by –
1. Change in the VAS score from the baseline to the 14th and 21st day.
- Change in the percentage score of Northwick Park Neck Pain Questionnaires from the baseline to the 14th and 21st day.
Secondary outcome
· SF-36 QOL assessment for any improvement from the baseline to the 14th day.
Treatment Period**-** 14 Days
Follow up period – 7 Days without treatment after the procedure (on 21st Day).
TREATMENT PROCEDURE
1-14 days – Jambeera PindaSweda in the Morning.
JAMBEERA PINDA SWEDA
The Jambeerapindasweda refers to the sudation performed by specially prepared bundles of Jambeera (citru acida) fruit pieces.
Material required:
Ingredients:
- Jambeera (chopped in to pieces)- 750 gm.
2. Saindhava- 30gm
- Turmeric powder- 60gm
4. RasnadiChurna- 5g.
5. Mahanarayan oil : For abhyanga- 100ml.
: For frying the ingredient-100ml.
: For reheating the Potali- Q.S
6. ksheerbala oil for talam-10ml
Preparation of potali:
Sliced lemon and other ingredients fried in 100 ml mahanarayan taila till the brown color appears. Then it should be divided in to 4 equal parts and made in to potalis accordingly.
Preoperative Procedure:
The Patient should be seated with leg extended on the droni and talam is applied with Ksheerabala taila.
Procedure:
Abhyanga should be performed with Ksheerabala taila. Out of the four Potalis ,the two potalis should be heated up to 40-450c by keeping on the hot pan containing Mahanarayan oil. These potalis are applied to the patients as per the general procedure for about 30-45 minutes.
Post operative Procedure:
After the procedure body should be wiped with clean towel, talam should be removed and Rasnadichoorna should be applied. The patient should be advised to take complete rest for half to one hour.
**METHODS OF ASSESSMENT
Prior to selection – (Screening)
· Informed Consent
·Eligibility evaluation
·Physical examination
·Visual Analogue Scale (VAS)
·Laboratory Investigations
·Digital X-ray Cervical Spine AP, Lateral and Oblique View.
During Selection-(Baseline o Day)
· General information-(Personal Identification and Demographic profile)
· Medical history, General Physical and Systemic examination
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.
· SF36 Questionnaire.
At the end of 7th day (during treatment)
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.
At the end of the treatment i.e. 14th day
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.
· SF36 Questionnaire.
At the end of 21st Day (Follow up without treatment)
· Physical examination and clinical assessment
· Visual Analogue Scale (VAS)
· Northwick Park Neck Pain Questionnaire.**
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cervical Spondylosis with clinical and radiological evidence of Cervical Spondylosis with or without cervical radiculopathy.
- •2.Willing Patients with informed consent obtained.
排除标准
- •Age below 30 years and above 65 years.
- •Cases of cervical Spondylosis with intractable pain, neurological deficit, severe deltoid or wrist extensors weakness.
- •Patients with any cervical pathology apart from Cervical Spondylosis excluding any clinical evidence of Cervical Spondylotic myelopathy.
- •Patients with poorly controlled Hypertension ( 140/90 mmHg).
- •Patients with poorly controlled Diabetes Mellitus having HbA1C of 7.5%
- •Patients with any hepatic or renal disorder, with liver enzymes twice the normal or S.
- •creatinine 1.4 mgm.
- •Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
2. Change in the percentage score of Northwick Park Neck Pain Questionnaires.
时间窗: 1. Change in the VAS score from the baseline to the 14th and 21st day. | 2. Change in the percentage score of Northwick Park Neck Pain Questionnaires from the baseline to the 14th and 21st day.
•Relief in Signs & Symptoms (pain and associated complaints) of the disease by –
时间窗: 1. Change in the VAS score from the baseline to the 14th and 21st day. | 2. Change in the percentage score of Northwick Park Neck Pain Questionnaires from the baseline to the 14th and 21st day.
1. Change in the VAS score
时间窗: 1. Change in the VAS score from the baseline to the 14th and 21st day. | 2. Change in the percentage score of Northwick Park Neck Pain Questionnaires from the baseline to the 14th and 21st day.
次要结局
- Improvement in health status by SF 36 Questionnaire(•SF-36 QOL assessment for any improvement from the baseline to the 14th day.)