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CTRI Number  CTRI/2023/11/060367 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 28/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To Compare The Effect Of Kati Basti With Mahamaasha Taila & I.F.T [Interferential Therapy] In Gridhrasi W.S.R To Sciatica 
Scientific Title of Study   A Comparative Clinical Study on The Effect Of Kati Basti With Mahamaasha Taila & I.F.T [Interferential Therapy] In Gridhrasi W.S.R To Sciatica 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Venkatesh Krishna Gaonkar 
Designation  P.G Scholar 
Affiliation  DHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE  
Address  Dept. of PG studies in Panchakarma,Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355
Dept. of PG studies in Panchakarma,Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355
Uttara Kannada
KARNATAKA
581362
India 
Phone  9480916289  
Fax  9480916289  
Email  venkateshgaonkar111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahalakshmi K M 
Designation  Reader 
Affiliation  DHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE, SIDDAPUR UTTARA KANNADA 
Address  Dept. of PG studies in Panchakarma,Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355

Uttara Kannada
KARNATAKA
581355
India 
Phone  9900979629  
Fax  9900979629  
Email  drmahalakshmi15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahalakshmi K M 
Designation  Reader 
Affiliation  DHANVANTARI AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE, SIDDAPUR UTTARA KANNADA 
Address  Dept. of PG studies in Panchakarma,Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355

Uttara Kannada
KARNATAKA
581355
India 
Phone  9900979629  
Fax  9900979629  
Email  drmahalakshmi15@gmail.com  
 
Source of Monetary or Material Support  
Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355  
 
Primary Sponsor  
Name  Dr Venkatesh Krishna Gaonkar  
Address  Dept. of PG studies in Panchakarma,Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkatesh Krishna Gaonkar  Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada  Dept. of PG studies in Panchakarma,Dhanvantari Ayurveda College Hospital And Research Centre, Siddapur Uttara Kannada -581355
Uttara Kannada
KARNATAKA 		 9480916289
9480916289
venkateshgaonkar111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dhanvantari Ayurveda College, Hospital and Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kaTibastiH, कटिबस्तिः (Procedure Reference: , Procedure details: Warm taila is uniformly poured into the constructed brim at extent 2 inches above the skin level. Taila is allowed to remain in the brim for 20 minutes. Temperature of the taila is maintained throughout the procedure by replacing warm taila. This procedure is repeated for 7 days)
2Comparator Arm (Non Ayurveda)-Interferential TherapyPatient is made to lie in prone position with lumbar region exposed adequately. 4 electrodes are placed in two pairs to be placed diagonal to each other over lumbar region. Regulation of current is to be done without causing discomfort to the patient.This procedure is carriedout for 20 mins for 7 days.
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Pain,Stiffness,Range of movements etc are assessed after Kati Basti with Mahamaasha Taila   7th day (after trial), Follow up on 14th and 21st days 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   09/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 SCIATICA”.

 

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 of DHANVANTARI 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.

 

 
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