| CTRI Number |
CTRI/2015/12/006449 [Registered on: 21/12/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/12/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a clinical trial on sandhigata vata (lumbar spondylosis) |
|
Scientific Title of Study
|
a clinical comparative study of agnikarma and raktamokshana in sandhigata vata with special referance to lumbar spondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR FORAM P JOSHI |
| Designation |
MS AYU SCHOLAR SHALYA |
| Affiliation |
IPGT AND RA, JAMNAGAR |
| Address |
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY HOSPITAL ROAD JAMNAGAR GUJARAT
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY HOSPITAL ROAD JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9924468211 |
| Fax |
|
| Email |
vd.fpjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VYASDEVA MAHANTA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
IPGT AND RA, JAMNAGAR |
| Address |
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY HOSPITAL ROAD JAMNAGAR GUJARAT
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY HOSPITAL ROAD JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9408323779 |
| Fax |
|
| Email |
drvyasayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR FORAM P JOSHI |
| Designation |
MS AYU SCHOLAR SHALYA |
| Affiliation |
IPGT AND RA, JAMNAGAR |
| Address |
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY HOSPITAL ROAD JAMNAGAR GUJARAT
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY HOSPITAL ROAD JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9924468211 |
| Fax |
|
| Email |
vd.fpjoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT RA GAU Jamnagar Gujarat India |
|
|
Primary Sponsor
|
| Name |
IPGT RA GAU Jamnagar Gujarat India |
| Address |
SHALYA TANTRA DEPARTMENT IPGT AND RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT 361008 |
| 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 FORAM P JOSHI |
ipgt and ra, gujarat ayurved university jamnagar |
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008 Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9924468211
vd.fpjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic lower backache
stiffness and restricted painfull lumbar joints movements, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AGNIKARMA |
GROUP A- MINIMUM 15 PATIENTS OF SANDHIGATA VATA(LUMBAR SPONDYLOSIS) WILL UNDER GO THROUGH AGNIKARMA. |
| Comparator Agent |
RAKTAMOKSHANA |
GROUP B- MINIMUM 15 PATIENTS OF SANDHIGATA VATA(LUMBAR SPONDYLOSIS) WILL UNDER GO THROUGH RAKTAMOKSHANA. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA 1.Patients suffering from Sandhigata Vata (lumbar Spondylosis). 2. Patients between age group 40-70 years of both sex.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA 1. Age below 40 years. 2. Patients of uncontrolled Diabetes Mellitus, R.A. +VE 3. Other diseases like Paralysis, Parkinson’s diseases, Severe Anemia, Malignancy. 4.Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of specially prepared Performa for assessing relief in sign and symptoms by scoring pattern |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of specially prepared Performa for assessing relief in sign and symptoms by scoring pattern |
60days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Treatment modalities like Agni karma and Raktamokshan are the non-pharmacological and result oriented therapies, recommended in Ayurveda for such type of disease condition. Hence, this study has been planned to carry out the comparative study to evaluate the efficacy of Agnikarma and Raktamokshana i.e. Sandhigata Vata (Lumbar spondylosis). |