| CTRI Number |
CTRI/2016/10/007391 [Registered on: 20/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
09/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of agnikarma and raktamokshan in backache |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of Agnikarma and Raktamokshana in Management of Gridhrasi Sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Durgesh Nandini |
| Designation |
M S Ayu Shalya Tantra |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
OPD No 11 Department of shalya tantra IPGT and RA Hospital Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9532108003 |
| Fax |
|
| Email |
durgesh8756@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Gupta |
| Designation |
PROF HOD |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
OPD No 11 Department of shalya tantra IPGT and RA Hospital Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428317639 |
| Fax |
|
| Email |
drskgupta17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S K Gupta |
| Designation |
PROF HOD |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
OPD No 11 Department of shalya tantra IPGT and RA Hospital Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428317639 |
| Fax |
|
| Email |
drskgupta17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute forPost GraduateTeaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India |
|
|
Primary Sponsor
|
| Name |
Institute forPost GraduateTeaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Institute forPost GraduateTeaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India 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 S K Gupta |
Institute forPost GraduateTeaching and Research in Ayurveda Jamnagar |
OPD NO 11
DEPARTMENT OF SHALYA TANTRA
Jamnagar
GUJARAT |
9428317639
drskgupta17@gmail.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 |
GRIDHRASI SCIATICA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
agnikarma |
Intervention Agnikarma
Shalaka Panchdhatu Shalaka
Type Bindu Dahana Vishesa
Dose 20 30 bindus sittings
Duration 4 Sittings on 1 week interval One month
Follow up period 1 Month
|
| Comparator Agent |
raktmokshan |
Intervention Raktamokshana
Instrument Modified Shringa Yantra
Site at Kati pradesha and 4 Angula below the Jaanu Sandhi Knee Joint
Number of Shringa 4 5 in Katipradesha and one at 4 Angula below the Jaanu Sandhi Knee Joint
Sitting 2 sittings at 15 days interval
Follow up period 1 Month after 15 days
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Gridhrasi sciatica
Patients of age group of 25- 65 years of either sex
Contolled Diabetes Mellitus
Contolled TB of spine & hip joint
Contolled Hypertension
|
|
| ExclusionCriteria |
| Details |
Uncontrolled Diabetes Mellitus
Uncontrolled TB of spine & hip joint
Malignancy
Fracture related to spine
Uncontrolled Hypertension
Heart diseases
Anemia
Pregnancy
Age below 25 and above 60 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
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 |
2 months |
|
|
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 |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
08/01/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a open label comparative clinical evaluation of agnikarma and raktamokshan in the management of gridhrasi sciatica routine blood investigation will be performed to rule out other systemic pathology x ray of L S spine A P and Lateral view will be carried out beore and after treatment special scoring scale has been prepared based on information in ayurvedic classical texts which will be utilized for assessment and evaluation |