| CTRI Number |
CTRI/2014/04/004552 [Registered on: 21/04/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Other (Specify) [Palliative and Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurved agnikarma (application of Heat) in Management osteoarthritis (OA) |
|
Scientific Title of Study
|
À clinical study of agnikarma and panchatikta guggulu in the management of sandhivata w.s.r to osteoarthritis of knee joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T S Dudhamal |
| Designation |
Assistant Professor |
| Affiliation |
IPGT and RA |
| Address |
Assistant Professor
Dept of Shalya Tantra
IPGT and RA
GAU
Jamnagar
Assistant Professor
Dept of Shalya Tantra
IPGT and RA
GAU
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesh V Sarma |
| Designation |
M S (sch) |
| Affiliation |
IPGT and RA |
| Address |
PG boys hostel room no 70
IPGT and RA
GAU
Jamnagar
Dept of Shalya Tantra
IPGT and RA
GAU
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7878226291 |
| Fax |
|
| Email |
sarma.anish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Assistant Professor |
| Affiliation |
IPGT and RA |
| Address |
Assistant Professor
Dept of Shalya Tantra
IPGT and RA
GAU
Jamnagar
Assistant Professor
Dept of Shalya Tantra
IPGT and RA
GAU
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Teaching Hospital
GAU
JAMNAGAR |
|
|
Primary Sponsor
|
| Name |
Post graduate teaching hospital |
| Address |
I P G T and R A gujrat ayurved university 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 T S Dudhamal |
department of Shalyatantra, first floor mof aswini bhavan building, Post Graduate Teaching Hospital |
IPGT & RA
GAU
Jamnagar
Jamnagar
GUJARAT |
9428671939
drtsdudhamal@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 |
Sandhigata vata
osteoarthritis knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AGNIKARMA |
PANCHADHATU SHALAKA
BINDU DAGDHA AROUND AFFECTED KNEE JOINT 04 SITTINGS ONE PER WEEK FOLLOW UP 1 MONTH |
| Comparator Agent |
PANCHATIKTA GHRITA GUGGULU AND AGNIKARMA |
PANCHATIKTA GHRITA GUGGULU 2 TAB OF 500MG EACH THRICE DAILY 1 HOUR AFTER MEAL WITH WARM MILK FOR 4 WEEKS
ORALLY
FOLLOW UP 1 MONTH
PANCHADHATU SHALAKA
BINDU DAGDHA AROUND AFFECTED KNEE JOINT 04 SITTINGS
ONE PER WEEK
FOLLOW UP 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)
Patients between age group 45-70years of both sex |
|
| ExclusionCriteria |
| Details |
1 Age below 45 years and above 70 years
2 Patients of Diabetes Mellitus Rheumatoid
arthritis Knee joint effusion
3 Other diseases like Paralysis Parkinson s
Disease Severe anaemia and malignancy
4 Secondary joint pain due to Tuberculosis AIDS
Leprosy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Betterment in Vedana Pain
Stambha Stiffness and Vata purna drutisparsha Crepitus will be assessed subjectively
Shotha Swelling
Gonometric measurement of flexion and extension of knee joint |
among 4 sittings every week patient will be assessed, and in the follow up period of 4 weeks also every week we will assess patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in X ray Knee joint |
Efficacy and saftey |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/03/2013 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis is the commonest form of joint disease and very painful disabling in advancing years. Patients of osteoarthritis need to take analgesics for daily and lifelong. In O A surgery knee joint replacement is very costly and patient has to continue analgesics for long duration. These analgesics and steroids in old age produce averse effects like gastritis hyperacidity renal failure etc. Agnikarma (therapeutic application of heat) which is a non pharmacological treatment relieves the clinical features of the condition without the use of analgesics for longer duration. The combined treatment modality of para surgical and oral medication is tried to assess the efficacy of agnikarma (theurapeutic heat) in one group and Agnikarma with panchatiktaka ghritha guggulu (ayurved medicated formulation) in another group. The agnikarma was done with a special panchadhatu Shalaka (metal rod designed with of five metals like Copper- 40%, Iron- 30%, Zinc- 10%, Silver- 10% and
Tin -
10% ). Agnikarma was done at medial and lateral site of affected knee joint. Total 15 bindu dagdha (dot like points were made with red hot metal rod) at every time for four times in a month. Agnikarma was done by weekly interval in four sitting in both groups. Assessment of relief in sign and symptoms was done after every seven days upto one month and followed up for one month. After completion of study encouraging result was observed in symptomatic relief. The re was complete pain relief in more than 80% patients after completion of treatment. ROM was improved in 50% of patients. In x-ray finding there was no change after completion of treatment as that was the structural defect. Finally study concluded that there is symptomatic relief with Agnikarma procedure in cases of OA knee joint. |