| CTRI Number |
CTRI/2025/12/099211 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two Ayurveda heat therapies to reduce thumb pain and improve hand movement in De Quervains disease |
|
Scientific Title of Study
|
A Pragmatic Clinical Trial to evaluate the effectiveness of Agnikarma with Ksaudra against Agnikarma with Pancaloha salaka in De-Quervains tenosynovitis |
| 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 FAHMA JEBIN K V M |
| Designation |
PG SCHOLAR |
| Affiliation |
VPSV Ayurveda College,Kottakkal |
| Address |
Department of Shalyatantra
VPSV Ayurveda college kottakkal Edarikode PO
Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
7034000587 |
| Fax |
|
| Email |
fahmaadnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunitha P V |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Shalyatantra
VPSV Ayurveda college kottakkal
Malappuram
Kerala
676501
India
Malappuram
KERALA
676501
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunitha P V |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Shalyatantra
VPSV Ayurveda college kottakkal
Malappuram
Kerala
676501
India
Malappuram
KERALA
676501
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda College Kottakkal |
| Address |
VPSV Ayurveda College Kottakkal Edaricode P.O Malappuram District Kerala Pin-676501 |
| Type of Sponsor |
Other [Aided 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 |
| Dr Fahma Jebin K V M |
VPSV Ayurveda College Hospital Kottakkal |
OPD Shalyatantra
VPSV Ayurveda College Hospital Kottakkal Room no 101A Edaricode PO Malappuram Kerala Pincode-676501
Malappuram
KERALA |
7034000587
fahmaadnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) VAIDYARATNAM P.S.VARIER AYURVEDA COLLEGE KOTTAKKAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M654||Radial styloid tenosynovitis [de Quervain]. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Susrutha samhitha-Sutrasthana-Chapter 12, Procedure details: Participants satisfying the inclusion criteria will be selected & randomly divided
into two groups.
Group I will undergo- Agnikarma with Ksaudra on 1st day
Group II will undergo -Agnikarma with pancaloha Salaka on 1st day
Duration of Assessment– 14 days
Follow up –45th day
PROCEDURE OF AGNIKARMA
• Based on the SOP followed in the Department of Shalyatantra,VPSV Ayurveda College
Hospital, Kottakkal.
• Ksaudra(honey) will be procured from FSSAI certified company
MATERIALS REQUIRED
• Betadine solution
• Sterile cotton
• Surgical gloves
• Kidney tray
• Sterile dish
• Honey
• Gas stove
• Borosilicate glass pipette
• Cow’s ghee
• Probe thermometer
• Swab holding forceps
• Pancaloha Salaka
Purvakarma
• All the prerequisites of Agnikarma will be collected.
• The procedure will be explained in detail, & written consent will be taken.
• The participant will be advised to take snigdha & slimy food (picchila anna) before
the procedure.
• The participant will be allowed to lie in the supine position, & the radial side of the
affected wrist will be exposed.
• The area over the tender points along the course of the tendon & around the radial
styloid process will be cleaned & made aseptic using betadine solution, & the five
predetermined sites will be marked.
• The surrounding area will be covered with sterile cotton.
Pradhana karma for Group -I
• A sufficient amount of honey will be taken in a sterile dish.
• The honey will be heated over the stove up to 110°C, & its temperature will be
measured with a probe thermometer.
• Five drops of honey (one drop at each site) in a bindu pattern will be dropped at the five
predetermined sites along the course of the tendon using a borosilicate pipette with a
stopper.
• An approximate 1 cm gap will be maintained between each drop, & the honey will be
wiped off after cooling using ghrta -soaked cotton
Pradhana karma for Group -II
• Pancaloha Salaka will be heated on a gas stove until it becomes red hot.
• The red-hot Pancaloha Salaka will be applied over the five predetermined sites along
the course of the tendon in a bindu pattern. An approximate 1 cm gap will be maintained
between each point of Salaka application.
Paścāt karma
• Madhu & ghrta will be applied immediately after the procedure over the sites of
Agnikarma.
• Participants will be observed for 30 minutes for any increase in pain.
• Participants will be advised to continue the application of honey & ghee for 1 week.
• The site will be observed on the assessment days.
• Internal medications will not be given to the participants during these days.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Susrutha samhitha-Sutrasthana-Chapter 12, Procedure details: Pradhana karma for Group -II
• Pancaloha Salaka will be heated on a gas stove until it becomes red hot.
• The red-hot Pancaloha Salaka will be applied over the five predetermined sites along
the course of the tendon in a bindu pattern. An approximate 1 cm gap will be maintained
between each point of Salaka application.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants satisfying diagnostic criteria of De-Quervains tenosynovitis
2.Participants having a VAS score of atleast 4 for pain
3.participants giving written informed consent |
|
| ExclusionCriteria |
| Details |
1.Participants who are contraindicated for Agnikarma
2.Participants with history of surgery,fractures of wrist joint and hand in the last 1 year
3.Participants with diagnosed cases of Rheumatoid arthritis and Gout
4.Pregnant women and lactating mother
5.Participants with diagnosed cases of uncontrolled Diabetes mellitus (HbA1C-greater than 7.5 percent) and uncontrolled hypertension(160/100 mmHg) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain using VAS Scale
Tenderness using tenderness grading scale |
1st day (before and after the procedure),8th,15th day and follow-up on 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Swelling using Swelling Grading Scale
Improvement in functional tests -Finkelstein test, Eichhoff’s test and WHAT test using
Grading Scale
Improvement in range of motion-active thumb abduction and active wrist ulnar
deviation, assessed using goniometer and Grading scale |
1st day (before and after the procedure),8th,15th day and follow-up on 45th day |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
De-Quervains tenosynovitis is a painful condition affecting the tendons on the radial side of the wrist, impairing thumb movement and daily activities. In Ayurveda, this condition can be correlated with Snayugata Vata, where Agnikarma is indicated as a primary line of treatment. This Pragmatic Clinical Trial aims to evaluate the relative effectiveness of Agnikarma with Ksaudra and Agnikarma with Pancaloha Salaka in managing De-Quervains tenosynovitis. A total of 34 participants satisfying the inclusion criteria will be randomly assigned into two groups at the Shalyatantra OPD of VPSV Ayurveda College Hospital, Kottakkal. Group I will undergo Agnikarma with Ksaudra and Group II will undergo Agnikarma with Pancaloha Salaka as a one-time intervention, with assessments on day 1 (before and after the intervention), day 8, day 15, and follow-up on day 45. Outcomes will be evaluated using clinical parameters including Visual Analogue Scale for pain, Tenderness-for primary objective and Swelling grading, Finkelstein’s Eichhoff’s test, WHAT test, and goniometric assessment for thumb abduction and wrist ulnar deviation for secondary objective. Data will be analyzed using appropriate statistical tools and outcome will be presented in the form of dissertation. The objective of this study is to determine the most appropriate Agnikarma approach for effective clinical management of De-Quervains tenosynovitis. |