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CTRI Number  CTRI/2020/08/027409 [Registered on: 26/08/2020] Trial Registered Prospectively
Last Modified On: 25/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFICACY OF INTERFERENTIAL THERAPY AND KATI BASTI IN GRIDHRASI W.S.R. TO SCIATICA 
Scientific Title of Study   A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF INTERFERENTIAL THERAPY AND KATI BASTI IN GRIDHRASI W.S.R. TO SCIATICA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Biraj Jung Khadka  
Designation  PG Scholar 
Affiliation  RGUHS 
Address  Department of PG Studies in Panchakarma,Sri Sri College of Ayurvedic Science And Research Hospital, Bengaluru 560082, Karnataka

Bangalore Rural
KARNATAKA
560082
India 
Phone  9980650068  
Fax    
Email  birajjungkhadka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Puttur 
Designation  Professor 
Affiliation  RGUHS 
Address  Department of PG Studies in Panchakarma,Sri Sri College of Ayurvedic Science And Research Hospital, Bengaluru 560082, Karnataka

Bangalore Rural
KARNATAKA
560082
India 
Phone  9448176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh Puttur 
Designation  Professor 
Affiliation  RGUHS 
Address  Department of PG Studies in Panchakarma,Sri Sri College of Ayurvedic Science And Research Hospital, Bengaluru 560082, Karnataka

Bangalore Rural
KARNATAKA
560082
India 
Phone  9448176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Source of Monetary or Material Support  
Dr. BIRAJ JUNG KHADKA, PG SCHOLAR, DEPARTMENT OF P.G STUDIES IN PANCHAKARMA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU 560082, KARNATAKA. 
 
Primary Sponsor  
Name  Dr Biraj Jung Khadka 
Address  Department of PG Studies in Panchakarma,Sri Sri College of Ayurvedic Science And Research Hospital, Bengaluru 560082, Karnataka 
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 Biraj Jung Khadka  Sri Sri College of Ayurvedic Science and Research, Bengaluru  Dept. of PG studies in panchakarma, sri sri college of ayurvedic science and research hospital, bengaluru 560082, karnataka
Bangalore Rural
KARNATAKA 
9980650068

birajjungkhadka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sri sri institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Efficacy of Interferential Therapy in the Gridhrasi.  Before procedure: Subject will be asked to lie down in prone position and the lower back will be lubricated with electrode gel. Procedure: The four electrodes will be arranged in two circuits- apply to the lower back at right angles to each other. Electrodes will be attached by bandages. Machine will be switched on & the required frequency will be selected. After procedure: After 20 minutes, machine will be switched off & electrodes will be removed. study duration and assessment: - on the 0 day before treatment and on the 7th day after treatment. 
Intervention  Efficacy of Kati Basti with Maha Vishagarbha taila in the Gridhrasi.  Kati Basti with Maha Vishagarbha taila will be given for 7 days. i. Poorva karma: Preparation of the Ring: Required quantity of water will be added to dihusked black gram powder so as to make ring of circular shape. Preparation of subject: At the time of Kati Basti, subject will be asked to lie down in prone position and the lower back will be exposed. ii. Pradhana karma: Required quantity of Luke warm Maha Vishagarbha Taila will be poured slowly inside the ring and heat will be maintained for 45 minutes by replacing the warm oil frequently. iii. Paschath Karma: Ring will be removed & lower back will be massaged. study duration and assessment: - on the 0 day before treatment and on the 7th day after treatment.  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects of either gender between the age of 21 and 65 years.
Subjects presenting with clinical signs and symptoms of Gridhrasi.
Subjects fit for Swedana.
Subjects fit for Interferential Therapy.
Subjects with signs and symptoms of Sciatica.
 
 
ExclusionCriteria 
Details  Subjects suffering with T.B. spine, tumors of spine, focal neuropathy and any septic or infectious disease of spine.
Subjects suffering with Diabetes or Diabetic neuropathy, Gout, Rheumatoid Arthritis, fracture of hip bones, fracture of spine.
Subjects who are unfit for Swedana.
Dermatological conditions e.g. dermatitis, broken skin
Subjects with Pacemakers.
Spondylolisthesis.
Pregnant and Lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Interferential therapy in Gridhrasi.
To evaluate the effect of Kati Basti in Gridhrasi.
To compare the effect of Interferential Therapy and Kati Basti in Gridhrasi.
 
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study kati basti procedure in detail.
To study Interferential therapy procedure in detail. 
7 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   01/09/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The most common disorder which affects the movement of leg is low back pain, out of which many persons will have radicular pain and this comes under the sciatica. The prevalence of sciatic symptoms reported in the literature varies considerably ranging from 1.6% in the general population to 43% in a selected working population1. Such presentations were common in olden period too and in Ayurveda it is named as Gridhrasi.

                Gridhrasi is a vataja nanatmaja vyadhi. The name itself indicates the way of gait shown by the patient due to extreme pain just like a ‘Gridhra’ (vulture)2. It is one of the commonly seen vata vyadhi in clinical practice. Though it is not a life threatening disease, it causes significant impairment in terms of the daily activities of the affected person.

               Swedana is an effective treatment modality in the management of Gridhrasi3. Gridhrasi is a shoolapradhana vatavyadhi. Shulavyuparama i.e. relief from pain is one of the samyak swinna lakshana4. Kati basti is an effective treatment in Gridhrasi as it acts both as snehana and swedana. Kati basti is selected in this study because of its simplicity and instant efficacy. Maha Vishagarbha taila is indicated in all types of Vata Vyadhi5. Hence, Maha Vishagarbha taila is chosen for kati basti.

        Physiotherapy is a medical treatment which involves the physical methods such as massage, heat treatment and exercise, rather than by drugs or surgery6. Interferential therapy is a form of electrical stimulation produced using the principle of amplitude modulation whereby two medium frequency currents (in the kilohertz range, e.g., 4,000 Hz), which are slightly out of phase, are mixed (either within the tissues or within an electrical stimulator) to produce a low frequency current(0-250 Hz)7. It is a form of electrical current that is primarily used for pain relief7,8. It is said to be effective in case of Low back pain9.

          Modern medical treatment has its own limitation in managing this type of disease. Therefore Ayurveda and physiotherapy has a greater role to play in the treatment for such conditions. Both Kati basti and Interferential therapy are heat modality treatments used in sciatica, hence the present study is intended to compare the efficacy of Interferential therapy and Kati basti in the treatment of Gridhrasi.


 
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