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Clinical Trials/CTRI/2023/11/060367
CTRI/2023/11/060367Not yet recruitingPhase 2

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 site in 1 country40 target enrollmentStarted: September 12, 2023Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Changes in Pain,Stiffness,Range of movements etc are assessed after Kati Basti with Mahamaasha Taila

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
25.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr Venkatesh Krishna Gaonkar
Sponsor Class
Other [self]

Study Sites (1)

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