| CTRI Number |
CTRI/2024/12/077594 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Agnikarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to see the effect of some Ayurvedic Intervention to compare Duration of Analgesia Achieved by Agnikarma and Tab. Diclofenac Sodiumwith only Tab. DiclofenacSodium in Management of Janusandhishoola With Special Reference to Osteoarthritis. |
|
Scientific Title of Study
|
A Clinical study to compare the Duration of Analgesia Achieved by Agnikarma and Tab. Diclofenac Sodium with only Tab. Diclofenac Sodium in Management of Janusandhishoola With Special Reference to Osteoarthritis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Babaji Auti |
| Designation |
Ms Scolar Shalyatantra (Ayurveda) |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8454938384 |
| Fax |
|
| Email |
snehaauti1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Narkhede |
| Designation |
MS (Shalya Tantra) Assistant Professor |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9850200998 |
| Fax |
|
| Email |
dryogeshnarkhede10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Narkhede |
| Designation |
MS (Shalya Tantra) Assistant Professor |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
MAHARASHTRA
411028
India |
| Phone |
9850200998 |
| Fax |
|
| Email |
dryogeshnarkhede10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Aarogya Kendra Malwadi Hadapsar Pune 411028 Maharashta India |
|
|
Primary Sponsor
|
| Name |
Sane guruji Aarogya Kendra Malwadi Hadapsar pune |
| Address |
OPD No 3 Department OF shalyatantra Sane Guruji Aarogya Kendra Malwadi Hadapsar Pune Maharashtra 411028 India |
| 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 Sneha Babaji Auti |
Sane Guruji Aarogya Kendra Malwadi Hadapsar Pune |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8454938384
snehaauti1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MAMs Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya kendra Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tablet Diclofenac Sodium 75 mg | Dose:tab Diclofenac sodium 75 mg 1BD ROute:Oral
Duration 3 days pragbhakt
Diclofenac has Analgesic,antiinflammatory and antipyretic properties. | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita, Procedure details: Supine position will be given maximum pain point will be selected & marked with marker Suvarna shalaka will be heated on the flame Agnikarma with Suvarna shalaka applied on selected point Agnikarma will be done on day 0 And Day 3 till samyak dagdha appear.goghrita will be applied on dagdh area Along with Tablet-Diclofenac sodium 75mg 1BD for 3 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Knee joint pain, stiffness, restricted movements of knee joint.
2. X-ray showing osteoarthritis.
3Age 40-70 yrs, irrespective of Gender & socio economic conditions. |
|
| ExclusionCriteria |
| Details |
1. K/C/O-HIV,
2. K/C/O-HBsAg,
3. K/C/O-DVT
4. K/C/O-Varicose vein,
5. K/C/O-Sciatica,
6. K/C/O-Rheumatoid Arthritis,
7. K/C/O-DM,
8. K/C/O-Diclofenac hypersensitivity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesia by Agnikarma plus Tab. Diclofenac
Sodium with Tab. Diclofenac Sodium individually.
|
15 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study reduction in pain. Improve knee joint Range Of Movement (ROM)
To observe the duration of analgesia in Osteoarthritis with both the
treatment. |
15 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Agnikarma has been explained as one among the Anushastra Having greater importance in the management of disease. use of NSAIDs for long duration they can cause potential side effects on body hence there is need to search for a safe option. so to avoid the adverse effects of it and to provide relief of symptoms,use of analgesics with Agnikarm can give more benefits. lot of research work has been done on Agnikarma in osteoarthritis,still to see whether we can minimize the use of analgesic and increase the Duration of Analgesia in Osteoarthritis,this comparative study has been taken. |