| CTRI Number |
CTRI/2019/05/018923 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
treatment of neck pain with shalaka (ayurvedic treatment ) |
|
Scientific Title of Study
|
a comparative study on the efficacy of agnikarma with loha shalaka and tamra shalaka in the mangement of sandhigata vata w.s.r cervical radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
jaydip patel |
| Designation |
pg student |
| Affiliation |
parul ayurveda hospital |
| Address |
opd no 116 , shalya department , parul ayurveda hospital , parul university , limda
Vadodara
GUJARAT
391760
India |
| Phone |
9979952774 |
| Fax |
|
| Email |
jbpatel1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H G TRIVEDI |
| Designation |
Professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
opd no 116 , shalya department , parul ayurveda hospital , parul university , limda
Vadodara
GUJARAT
391760
India |
| Phone |
9773412926 |
| Fax |
|
| Email |
trivedi0hari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr suresh pandya |
| Designation |
Professor |
| Affiliation |
parul ayurveda hospital |
| Address |
opd no 116 , shalya department , parul ayurveda hospital , parul university , limda
GUJARAT
391760
India |
| Phone |
9427899033 |
| Fax |
|
| Email |
sureshpandya912@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurveda and hospital , limda , vadodra ,Gujarat |
|
|
Primary Sponsor
|
| Name |
Department Of Shalya Tantra |
| Address |
parul institute of ayurveda ,parul university , limda vadodra |
| Type of Sponsor |
Private medical college |
|
|
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 |
| jaydip patel |
parul ayurveda hospital |
opd no 116, shalya department ,parul institute of ayurveda and hospital , parul university , limda ,vadodra
Vadodara
GUJARAT |
9979952774
jbpatel1992@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, patient suffering from tingling sensation in upper limbs , , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
loha shalaka |
a pure iron shalaka is made and heated on fire till it gets red hot and it is applied on neck region where there is pain , once in evry 7 days |
| Comparator Agent |
tamra shalaka |
pure copper shalaka is made and heated on fire till it gets red hot and it is applied on neck region where there is pain , once in evry 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients fullfill in diagnostic criteria |
|
| ExclusionCriteria |
| Details |
history of trauma , tuberculosis of spine , tumour , and uncontrolled diabetes |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain will be reduced |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stiffness will be reduced |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/05/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
alternative hypothesis - in sandhigata vata the efficacy of agnikarma with tamra shalaka is better then the efficacy of agnikarma with loha shalaka |