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临床试验/CTRI/2023/11/060367
CTRI/2023/11/060367尚未招募2 期

A Comparative Clinical Study on The Effect Of Kati Basti WithMahamaasha Taila & I.F.T [Interferential Therapy] In GridhrasiW.S.R To Sciatica

Dr Venkatesh Krishna Gaonkar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月12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
40
试验地点
1
主要终点
Changes in Pain,Stiffness,Range of movements etc are assessed after Kati Basti with Mahamaasha Taila

研究概览

简要总结

TITLE OF THE STUDY:

"A COMPARITIVE CLINICAL STUDY ON THE EFFECT OF KATI BASTI WITH MAHAMAASHA TAILA & I.F.T [INTERFERENTIAL THERAPY] IN GRIDHRASI W.S.R TO SCIATICAâ€.

 Summary:

Kati Basti is the modification of Snigdha Basti in which sneha usually medicated taila is allowed to stay for a stipulated time over the lumbar spine area, commonly used in pain and inflammatory conditions of the spine . To place the oil a brim of circular or elongated is constructed and the oil is placed for time period maintaining the temperature. It is easy and can be administered without any complication. Mahamaasha Tailam is a unique preparation exclusively indicated in the management of Gridhrasi and it is in practice too.

On the other hand Interferential therapy which is one among the electro-physiotherapy is also widely practiced modality of treatment of sciatica.

 OBJECTIVE OF THE STUDY :

1.     To evaluate the efficacy of Kati Basti with Mahamaasha Taila in Gridhrasi  w.s.r. to Sciatica.

2.     To evaluate the efficacy of I.F.T.( Interferential Therapy) in  Gridhrasi  w.s.r. to Sciatica.

3.     To compare the efficacy of Kati Basti and I.F.T. in Gridhrasi  w.s.r. to Sciatica.

 MATERIALS AND METHODS:

 SAMPLE SOURCE : A minimum of 40 patients will be selected randomly  from IPD & OPD ofDHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE SIDDAPUR (U.K.) and equally devided into 2 groups  of 20 patients each in Kati Basti with Mahamaasha Taila group and I.F.T. group.

 METHOD OF COLLECTION OF DATA

 A) **STUDY DESIGN :**Present study is A COMPARITIVE clinical study.

B) **SAMPLING TECHNIQUE :**The subjects who fulfill  the inclusion criteria and exclusion criteria complying with the informed consent(IC) will be selected randomly for the study.

C)  SAMPLE SIZE : A minimum of 40 patients fulfilling the inclusion criteria and exclusion criteria of Ghridhrasi  will be selected and equally divided into two groups i.e. 20 patients in each group for the study irrespective of gender, religion, occupation and economic status.

D) **DESIGN OF STUDY :**A clinical study with minimum of  40 patients of Gridhrasi of either gender , aged between  25-65 years will be carried out as part of the research. The signs and symptoms will be assessed before and after treatment.

Group A :  20 patients will be subjected to Kati Basti with Mahamaasha Taila.

Group B :  20 patients will be  subjected to Interferential Therapy.

ASSESSMENT :

Patients will be assessed on 0th day i.e. before treatment , 7th day i.e. after treatment  and follow up assessment will be done on  14th day and 21st day.

 SUBJECTIVE PARAMETERS:

The assessment of results of treatment will be done on the basis of numerical scores assigned for each of the following signs and symptoms;

1.     Ruk (continuous pain) in the sphik, Kati, Uru Janu Jangha and Pada

2.     Toda (intermittent pain) in the sphik, Kati, Uru, Janu Jangha and Pada.

3.     Stambha (stiffness) in the sphik, Kati, Uru Janu Jangha and Pada.

4.      Spandana (fasciculation) in the sphik, Kati, Uru,Janu, Jangha and Pada.

 OBJECTIVE PARAMETERS:

1.     Walking distance.

2.     Sitting.

3.     Straight Leg Raising Test.

4.     Crossed SLR Test

5.     Femoral nerve stretch test/ Reverse SLR test

6.     Slump test

7.     Lasegue’s test

8.     Faber  test

9.     Bowstrings test

10.  Braggard’s Test.

11.  Visual Analog Scale

ASSESSMENT CRIETERIA:

A detailed proforma will be prepared for the assessment of subjective and objective parameters by grading them. The data obtained will be analyzed statistically with suitable method.

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
25.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with pratyatma lakshana of Gridhrasi ( as per Charaka Chikitsa 28/56) 2.Patients between age 25-65 yrs.
  • 3.Patients with IVDP, spondylosis with noninvolvement of urinary bladder and rectum.
  • 4.Patients fit for Kati Basti.
  • 5.Patients fit for I.F.T.

排除标准

  • 1.Patient with neoplastic condition of spine.
  • 2.Trauma of lumbar vertebra.
  • 3.Infection of spine.
  • 4.TB of spine or hip.
  • 5.Pregnant women.
  • 6.Patients with wounds or any injury over lumbar region.
  • 7.Dermatological conditions 8.Patients with any metal implantation or with pacemakers.
  • 9.Patient not fit for Kati Basti.

结局指标

主要结局

Changes in Pain,Stiffness,Range of movements etc are assessed after Kati Basti with Mahamaasha Taila

时间窗: 7th day (after trial), Follow up on 14th and 21st days

次要结局

  • Changes in Pain,Stiffness,Range of movements etc are assessed after I.F.T. (Interferential Therapy)(7th day (after trial), Follow up on 14th & 21st days)

研究者

发起方
Dr Venkatesh Krishna Gaonkar
申办方类型
Other [self]

研究点 (1)

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