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CTRI Number  CTRI/2021/03/032470 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 29/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL STUDY TO SEE THE EFFECT OF BALA TAILA ENEMA IN LOW BACK ACHE RADIATING TO LOWER LIMB 
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF BALA TAILA MATRA BASTI IN GRIDHRASI 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yadukrishnan V P 
Designation  Final year PG Scholar 
Affiliation  Alvas Ayurveda Medical College and Hospital vidyagiri moodbidri 
Address  Department of Panchakarma Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri Dakshina kannada district

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8431159213  
Fax    
Email  yadukrishnan10793@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen B S 
Designation  Professor HOD Department of Panchakarma 
Affiliation  Alvas Ayurveda Medical College and Hospital vidyagiri moodbidri 
Address  Department of Panchakarma Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri Dakshina kannada district

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9964006795  
Fax    
Email  praveenbs76@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yadukrishnan V P 
Designation  Final year PG Scholar 
Affiliation  Alvas Ayurveda Medical College and Hospital vidyagiri moodbidri 
Address  Department of Panchakarma Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri Dakshina kannada district

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8431159213  
Fax    
Email  yadukrishnan10793@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYYAGIRI MOODBIDRI 
 
Primary Sponsor  
Name  Dr Yadukrishnan V P 
Address  Valamputhussery illam vakayad po naduvannur VIA calicut kerala 673614 
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 Yadukrishnan V P  Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri  Panchakarma theatre Department of Panchkarma Room number 201 2nd floor Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri Dakshina Kannada
Dakshina Kannada
KARNATAKA 		 8431159213

yadukrishnan10793@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethics Committee Alvas Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRIDHRASI,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Matra basti with Balataila   Poorva karma -Patient is made to lay down sthanika abyanga with bala taila is done over lower abdomen buttocks and thigh region followed by nadi sweda Pradhana karma- patient is made to lie down on left lateral position with right leg flexed at knee and left leg fully extended matrabasti is given with Bala taila (72 ml) using basti syringer paschath karma-patient is made to li down in supine position with legs slightly raised for 15mins. 
Comparator Agent  matra basti with sahachara taila  Poorva karma -Patient is made to lay down sthanika abyanga with sahachara taila is done over lower abdomen buttocks and thigh region followed by nadi sweda Pradhana karma- patient is made to lie down on left lateral position with right leg flexed at knee and left leg fully extended matrabasti is given with sahachara taila (72 ml) using basti syringer paschath karma-patient is made to li down in supine position with legs slightly raised for 15mins. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients with symptoms of radiating pain from sphik(buttock) and kati(lumbar region) to prishta(back), uru(thigh), janu(knee), janga(calf) and pada(feet)
patients who are fit for basti karma 
 
ExclusionCriteria 
Details  Traumatic, Infective, Degenerative condition of spine.
Congenital spinal anomalies.
Pregnant and Lactating Women.
Patients who is contra indicated for basti karma. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ruk(pain)
stamba(stiffness)
toda (pricking sensation)
tandra(weakness)
gaurava(heaviness)
aruchi(anorexia)
sciatica frequency index
sciatica bothersomeness index
 		 60 days
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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/ Phase 3 
Date of First Enrollment (India)   08/04/2021 
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="0"
Months="2"
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   It is a randomized controlled clinical study to evaluate the efficacy of Bala Taila Matra Basti in Gridhrasi. Study consists of two groups a trial group(Bala Taila Matra Basti) and a control group( Sahachara Taila Matra Basti). 40 patients of Grudrasi (20 each group) are selected by randomization technique from Alvas Ayurveda Medical College. The patients of respective group are administered with respective Matra Basti for a period of 7 days. The pre and post treatment assessments are made and the follow up is done on the 14th day, 30th day, 45th day and 60th day. 
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