| CTRI Number |
CTRI/2025/03/083741 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO EVALUATE THE EFFICACY OF PRATISARANA TYPE OF AGNIKARMA WITH MRUTTIKA SHALAKA IN THE PAIN MANAGEMENT CAUSED DUE TO ACHILLES TENDINITIS |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PRATISARANA AGNIKARMA WITH MRUTTIKA SHALAKA IN THE MANAGEMENT OF GULPHASTHITHA SNAYUGATA VATA WITH SPECIAL REFERENCE TO ACHILLES TENDINITIS |
| 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 CHINNI VISHNU |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science Hospital and Research, 21st KM, Kanakapura main road, Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India |
| Phone |
8747925721 |
| Fax |
|
| Email |
chinnivishnu797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIVEK J |
| Designation |
PROFESSOR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science Hospital and Research, 21st KM, Kanakapura main road, Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India |
| Phone |
9945314963 |
| Fax |
|
| Email |
ayurvedabhishak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHINNI VISHNU |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science Hospital and Research, 21st KM, Kanakapura main road, Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India |
| Phone |
8747925721 |
| Fax |
|
| Email |
chinnivishnu797@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH, KANAKAPURA MAIN ROAD, UDAYAPURA POST, BENGALURU - 560082 |
|
|
Primary Sponsor
|
| Name |
Dr CHINNI VISHNU |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science hospital and Research, 21st KM, Kanakapura main road, Udayapura Post, Bengaluru- 560082 KARNATAKA India |
| Type of Sponsor |
Other [SELF] |
|
|
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 CHINNI VISHNU |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science hospital and Research, 21st KM, Kanakapura main road, Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA |
8747925721
chinnivishnu797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M766||Achilles tendinitis. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: sushrutha sutra sthana chapter 12, Procedure details: Subject is allowed to lie in prone position. The site of Agnikarma will be cleaned with normal saline. The most tender area will be identified. After heating of the Mruttika Shalaka, Pratisarana Agnikarma will be done over identified areas by rubbing the Shalaka thrice from above downwards. Then immediately Madhu Sarpi mixture will be applied over Agnikarma area)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: sushrutha sutra sthana chapter 12, Procedure details: Subject is allowed to lie in prone position. The site of Agnikarma will be cleaned with normal saline. Mark the most tender points with pen. Using a pipette heated Kshaudra is taken up & dropped over the marked site for 1-2 seconds & wiped off immediately using Madhu-Sarpi mixture)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with age of 21 – 60 years irrespective of gender, religion, caste, race or socio-economic status and who are willing to give consent.
2. Subjects fulfilling the diagnostic criteria of Achilles tendinitis |
|
| ExclusionCriteria |
| Details |
1. Subjects suffering from diabetic neuropathy, foot drop.
2. Subjects with fracture of calcaneum & paget’s disease affecting calcaneum.
3. Subjects with rupture of Achilles tendon.
4. Subjects associated with sever systemic diseases and auto immune disorders will be excluded.
5. Subjects with foot related surgical history |
|
|
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 see the significant reduction in pain, tenderness and improvement in range of movements of ankle joint.
|
0th day, 7th day, 14th day, 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the significant improvement in the quality of life based on code AQoL-8D, SF-36, EQ-5D and VISA-A survey affected with Achilles tendinitis
reduced pain, swelling and range of motion of ankle affected with Achilles tendinitis |
28th day |
|
|
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)
|
21/04/2025 |
| 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="2"
Months="0"
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
|
THIS STUDY HAS BEEN TAKENUP TO EVALUATE THE EFFICACY OF PRATISARANA AGNIKARMA WITH MRITTHIKA SHALAKA IN THE MANAGEMENT OF ACHILLES TENDINITIS
COMPARISION WITH BINDU AGNIKARMA WITH KSHAUDRA
RESEARCH QUESTION :
Whether Pratisarana Agnikarma with Mruttika Shalaka is effective
in the
management
of
Gulpha
Sthitha
Snayugata
Vata with special reference to
Achilles tendinitis?
NULL HYPOTHESIS –
H0 - There is no significant difference
in efficacy of Pratisarana Agnikarma with Mruttika Shalaka and Bindu Agnikarma with Kshaudra in the management of Gupha Sthitha Snayugata Vata with special reference to Achilles tendinitis.
ALTERNATIVE HYPOTHESIS –
H1 - Pratisarana Agnikarma with Mruttika Shalaka is more effective than Bindu Agnikarma with Kshaudra in the management of Gulpha Sthitha Snayugata Vata with
special reference to Achilles tendinitis.
H2 –Bindu Agnikarma with Kshoudra is more effective than Pratisarana Agnikarma with Mruttika Shalaka in the management of Gulpha Sthitha Snayugata Vata with special reference to Achilles
tendinitis. |