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CTRI Number  CTRI/2022/03/041492 [Registered on: 30/03/2022] Trial Registered Prospectively
Last Modified On: 29/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF SAHACHARADI TAILA MATRA BASTI IN THE MANAGEMENT OF KATISHOOLA VIS-A-VIS LOW BACK PAIN. 
Scientific Title of Study   RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF SAHACHARADI TAILA MATRA BASTI IN THE MANAGEMENT OF KATISHOOLA VIS-A-VIS LOW BACK PAIN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SUNEERA VED PRAKASH BANGA 
Designation  M D SCHOLAR PANCHAKARMA 
Affiliation  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA 
Address  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE OPD NO 6 DEPARTMENT OF PANCHAKARMA SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE

Pune
MAHARASHTRA
411028
India 
Phone  8570063732  
Fax    
Email  drsuneerabanga@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VANDANA AVHAD 
Designation  ASSOCIATE PROFESSOR DERARTMENT OF PANCHAKARMA 
Affiliation  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA 
Address  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE OPD NO 6 DEPARTMENT OF PANCHAKARMA SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE

Pune
MAHARASHTRA
411028
India 
Phone  9890608788  
Fax    
Email  drvandanapalve@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SUNEERA VED PRAKASH BANGA 
Designation  M D SCHOLAR PANCHAKARMA 
Affiliation  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA 
Address  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE OPD NO 6 DEPARTMENT OF PANCHAKARMA SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE

Pune
MAHARASHTRA
411028
India 
Phone  8570063732  
Fax    
Email  drsuneerabanga@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PANCHAKARMA SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE 411028 
 
Primary Sponsor  
Name  SANE GURUJI AROGYA KENDRA 
Address  DEPARTMENT OF PANCHAKARMA SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE 411028 
Type of Sponsor  Research institution and hospital 
 
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 SUNEERA VED PRAKASH BANGA  SANE GURUJI AROGYA KENDRA  OPD NO 6 DEPARTMENT OF PANCHAKARMA SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE
Pune
MAHARASHTRA 		 8570063732

drsuneerabanga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: KATISHOOLA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: , Procedure details: SAHACHARADI TAILA IS A FORMULATION OF AYURVEDIC HERBS TN FORM OF OIL. MATRA BASTI OF SAHACHARADI TAILA WILL BE ADMINISTERED FOR 8 DAYS IN PATIENTS OF KATISHOOLA)
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: , Procedure details: TILA TAILA IS A FORMULATION OF AYURVEDIC HERBS TN FORM OF OIL. MATRA BASTI OF TILA TAILA WILL BE ADMINISTERED FOR 8 DAYS IN PATIENTS OF KATISHOOLA)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  PATIENTS HAVING SYMPTOMS OF KATISHOOLA.
BASTI ARHA.
GENDER BOTH MALE AND FEMALE.
AGE 20 TO 60 YEARS. 
 
ExclusionCriteria 
Details  PATIENTS HAVING CONGENITAL STRUCTURAL DEFORMITIES
PATIENTS HAVING OTHER JOINT DEFORMITIES OR DISEASES WHICH ARE NOT RELATED TO KATISHOOLA
PATIENTS WITH SYSTEMIC DISEASE WHICH MAY CAUSE INTERFERENCE IN THE TREATMENT OF STUDY WILL BE EXCLUDED 
 
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 SAHACHARADI TAILA MATRA BASTI IN THE MANAGEMENT OF KATISHOOLA.  TREATMENT WILL BE GIVEN FOR 8 DAYS. PATIENTS WILL BE ASSESSED ON 0, 4, 8 AND 15TH DAY. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 1/ Phase 2 
Date of First Enrollment (India)   04/04/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   THIS IS A COMPARATIVE CLINICAL STUDY OF MATRA BASTI OF TWO DRUGS OF SAHACHARADI TAILA  AND TILA TAILA IN KATISHOOLA . THE PRIMARY OBJECTIVE IS TO EVALUATE THE EFFECT OF SAHACHARADI TAILA MATRA BASTI  AS  MODALITIES ARE SAME FOR BOTH DRUGS. ONE GROUP OF KATISHOOLA WILL BE TREATED WITH MATRA BASTI OF SAHACHARADI TAILA FOR 8 DAYS. SECOND GROUP OF KATISHOOLA WILL BE TREATED WITH MATRA BASTI OF TILA TAILA FOR 8 DAYS. OBSERVATION WILL BE DRAWN FROM THE OUTCOME OF PATIENTS. 
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