| CTRI Number |
CTRI/2015/07/006026 [Registered on: 20/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
20/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Agnikarma with panchtikta guggulu in knee joint pain |
|
Scientific Title of Study
|
A Further Study on Agnikarma with Panchatikta
Guggulu in the Management of Sandhigatavata w.s.r. to Knee Joint Osteoarthritis
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S K GUPTA |
| Designation |
MS Ayu Ph D |
| Affiliation |
IPGTRA |
| Address |
DEPARTMENT OF SHALYATANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
DEPARTMENT OF SHALYATANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
09428317639 |
| Fax |
|
| Email |
drskgupta17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARTH PANDYA |
| Designation |
MS Ayu SCHOLAR |
| Affiliation |
IPGTRA |
| Address |
DEPARTMENT OF SHALYATANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
DEPARTMENT OF SHALYATANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
09033640082 |
| Fax |
|
| Email |
drparthpandya88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S K GUPTA |
| Designation |
MS Ayu Ph D |
| Affiliation |
IPGTRA |
| Address |
DEPARTMENT OF SHALYATANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
DEPARTMENT OF SHALYATANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
09428317639 |
| Fax |
|
| Email |
drskgupta17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGTRA GAU |
| Address |
IPGTRA GAU Jamnagar |
| 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 |
IPGTRA |
DEPARTMENT OF SHALYTANTRA IPGTRA GUJARAT AYURVED UNIVERSITY JAMNAGAR
Jamnagar
GUJARAT |
09428317639
drskgupta17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC IPGTRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
knee joint pain swelling decreased knee joint movements crepitations in knee joint stiffness of knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnikarma |
Agnikarma locally done at knee joint carried out weekly for 1 month
|
| Comparator Agent |
Panchtikta guggulu |
Panchtikta guggulu tablet 1gm thrice given orally for 1 month |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Janugata Sandhivata (O.A. of knee joint) |
|
| ExclusionCriteria |
| Details |
Age below 45 years and above 70 years
Patients of Diabetes mellitus, R.A (Rheumatoid Arthritis) positive, Knee Joint Effusion
Other Diseases like Paralysis, Parkinson’s disease, severe Anemia, Malignancy
Pregnancy
Sandhigata Vata other than Janugata Sandhivata
Known cases of secondary O.A. due to T.B., Syphilis, AIDS, Leprosy etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve from sign and symptoms of osteoarthritis like pain swelling tenderness stiffness flexion and extension of knee joints |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in symptoms of osteoarthritis
improve quality of life |
2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2014 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was an open randomized parallel group trial to validate the effect of Agnikarma and Panchtikta Guggulu in management of Janusandhigata Vata(knee joint osteoarthritis). Total 30 patients were allocated randomly into two groups. 15 patients were treated by Agnikarma and 15 patients were treated by Agnikarma along with Panchtikta Guggulu tablet orally. Agnikarma was dont at afected knee joint by Panchdhatu shalaka. Agnikarma procedure was carried out at weekly intervals and total four sittings were done. Panchtikta Gugglu tablets were given orally 2 tablets thrice a day with luke warm water for. Duration for both the treatments was 1 month. In cardinal symptoms of Janugata sandhivata, 53.33% patients showed marked improvement and 26.67% patients got moderate improvement after Agnikarma in group A where only Agnikarma was done. In group B where Agnikarma done along with orally given Panchtikta Guggulu 46.67% patients got marked improvement and 33.33% patients got moderate improvement. The study was concluded that on the basis of relief % in cardinal symptoms Agnikarma along with Panchtikta Gugglu tablet orally had better effect than only Agnikarma.
|