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CTRI Number  CTRI/2019/07/020353 [Registered on: 24/07/2019] Trial Registered Prospectively
Last Modified On: 23/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma Procedure ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of medicated ghee with enema treatment along with local procedure in low backache . 
Scientific Title of Study   A comparitive clinical study on the efficacy of Panchatikta Ghrita with ksheera as snehapana and as ksheera basti along with kati basti in katishoola w.s.r. lumber degenerative disc disease. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neelam kaalia 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda  
Address  Department of Panchakarma ,7th floor, All India Institute of Ayurveda, Sarita Vihar , New Delhi -110076

South West
DELHI
110076
India 
Phone  7838495779  
Fax    
Email  neelamkaalia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santosh Kumar Bhatted  
Designation  Associate Professor  
Affiliation  All India Institute of Ayurveda 
Address  Department of Panchakarma, 7th floor ,All India Institute of Ayurveda ,Sarita Vihar , New Delhi - 110076

South
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Santosh Kumar Bhatted  
Designation  Associate Professor  
Affiliation  All India Institute of Ayurveda 
Address  Department of Panchakarma , 7th floor ,All India Institute of Ayurveda ,Sarita Vihar , New Delhi - 110076

South
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda ,Sarita Vihar , New Delhi - 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda  
Address  All India Institute of Ayurveda ,Sarita Vihar , New Delhi - 110076 
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 Santosh Kumar Bhatted  All India Institute of Ayurveda   Department of Panchakarma , 7th floor,All India Institute of Ayurveda ,Sarita Vihar , New Delhi - 110076
South
DELHI 
9414048459

santoshbhatted@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M85||Other disorders of bone density and structure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of ksheera basti with panchatikta ghrita along with kati basti with dhanwantar taila in katishoola.  paachana for 5 days with koshtha shudhi on 6th day. Group 2- Ksheera basti with Panchatikta ghrita for 8 days and 7 days parihara kala followed by katibasti with Dhanwantar taila for 8 days . administration of tryodashanga guggulu for 30 days .follow up period - 61th -90th day. 
Intervention  Effect of Panchatikta ghrita with ksheera as snehapana in katishoola  paachana for 5 days with koshtha shudhi on 6th day Group 1- senehapana with panchatikta ghrita for 15 days followed by katibasti with dhanwantar taila for 8 days. administration of tryodashanga guggulu for 30 days. follow up period - 61th-90th day 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  clinical presentation of katishoola
chronicity of disease <10 yrs
diagnosed lumbar degenerative disc disease
socio-economic status -all 
 
ExclusionCriteria 
Details  ANY TRAUMATIC CONDITIONS OF SPINE & HIP
RHEUMATOID ARTHRITIS , GOUT
PREGNANCY AND LACTATION
OTHER SYSTEMIC DISORDERS
CONTRAINDICATIONS OF BASTI AND SNEHAPANA IN RESPECTIVE GROUP. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain
 
90 days  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life by Maine Seatle Back Questionnaire  90 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 2 
Date of First Enrollment (India)   15/08/2019 
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)?  

Brief Summary  


OBJECTIVES OF THE RESEARCH PROJECT:

PRIMARY:

To compare the efficacy of  Snehapana with Panchatikta Ghrita with that of  Ksheera Basti with Panchatikta Ghrita along with Kati Basti with Dhanwantar Taila[i] in terms of pain management in Kati Shoola  (low back pain) due to Lumbar Degenerative Disc Disease.

SECONDARY:

To evaluate the efficacy of  Snehapana with Panchatikta Ghrita with that of  Ksheera Basti with Panchatikta Ghrita along with Kati Basti with Dhanwantar Taila in improving the quality of life in patients of Kati Shoola  (low back pain) due to Lumbar Degenerative Disc Disease.

SELECTION CRITERIA:

INCLUSION CRITERIA

EXCLUSION CRITERIA

1. Age group 25- 70 years of either gender

1. Any traumatic conditions of spine & hip

2. Clinical presentation of Katishoola

2. Rheumatoid arthritis, Gout

3. Chronicity of disease < 10 yrs

3. Pregnancy and lactation

4. Diagnosed Lumbar Degenerative Disc Disease.

4. Other systemic disorders

5. Socio Economic status - all

5. Contra- indications for Snehapana or Basti Karma in respective group

  CRITERIA FOR DIAGNOSIS

1.Clinical examination
2. Low back pain
3. Bragard’s sign
4. Radiological evidences like MRI of lumbar spine (if available) to assess the degenerative changes in the lumbar disc.

5. S.L.R. test

FOR ASSESSMENT OF STUDY OUTCOMES:

1)    Oswestry low back pain disability questionnaire.

2)    Quebec back pain disability scale.

3)    Lumbar spine mobility test.

4)    The low back outcome score (LBOS) scale of Greenough & Fraser.

5)    Quality of life by Maine Seattle Back Questionnaire.


 
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