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
|
|
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
|
|
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.
|