| CTRI Number |
CTRI/2026/01/102165 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [PROCEDURE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Kanji Yukta Patrapottali And Kanji Dhara Therapy For Pain Relief In Patients With Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Kanji Yukta Patrapottali And Kanji Dhara In The Pain Management Of Amavata W.S.R To Rheumatoid Arthritis |
| 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 Monali Prakash Keni |
| Designation |
MD Scholar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Kharghar |
| Address |
Panchakarma Dept Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Raigarh Maharashtra 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9372492717 |
| Fax |
|
| Email |
moalikeni29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpna Gholap Dhomse |
| Designation |
HOD And Professor |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Kharghar |
| Address |
Panchakarma Dept Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Raigarh Maharashtra 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
|
| Email |
kalpu.gholap@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpna Gholap Dhomse |
| Designation |
HOD And Professor |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Kharghar |
| Address |
Panchakarma Dept Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Raigarh Maharashtra 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
|
| Email |
kalpu.gholap@gamil.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurvedic Medical College And Hospital Kharghar Navi Mumbai 410210 India |
|
|
Primary Sponsor
|
| Name |
Dr Monali Prakash Keni |
| Address |
Panchakarma Dept Dr G D Pol Foundation YMT Ayurvedic College And Hospital Institutional Area Kharghar 410210 |
| 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 MONALI PRAKASH KENI |
Ymt Ayurvedic Medical College And Hospital Kharghar |
Ground Floor Panchakarma OPD YMT Ayurvedic Medical College And Hospital Institutional Area Sector 04 Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
9372492717
monalikeni29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DR GD POL FOUNDATION YMT AYURVEDIC MEDICAL COLLEGE AND CHARITABLE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरस्वेदः | (Procedure Reference: Keraliya Chikitsa Paddhaith, Procedure details: 1.Poorva Karma = Preparation 0f Patrapottali Pinda Ark,Nirgundi,Shigru,Eranda,Chinchapatra Leaves Are Cut Into Small Pieces And Fried In The Pan With Grated Coconut And Oil Till It Turns Brown. Mixture Is Divided Into Equal Parts And Tied In The Form Of Bollus.Patient Should Be Examined And Informed About Procedure And Be Given Proper Position Over The Dhroni.
2.Pradhan Karma =The Bolus Is Dipped In The Kanji Heated Over Mild Flame.Bolus Are Rubbed Over The Affected Area After Checking The Heat .The Bolus Is Repeatedly Heated In The Kanji.The Procedure is continue for 15 to 30 Mins.
3.Paschyat Karma= Wipe Off The Body And Cover With Cloth For 15 mins.
These Procedure Is Done For 7 Days.)
| | 2 | Comparator Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Shushruta Samhita Chikitsasthan 32/13, Procedure details: 1.Poorva Karma= The Patient Is Examined And Given Proper Position On Dhroni.
2.Pradhan Karma= The Warm Kanji Is Continuously Poured Over The Body Of Affected Area In A Rhythmic Manner For 30-40 Mins.
3.Paschyat Karma= Wipe Off The Body Parts And Allow To Rest For 15 Mins.
This Procedure Is Done For 7 Days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Showing Signs And Symptoms Mentioned In Classical Ayurveda Text (Sandhi Shool,Sandhi Shotha,Sandhi stabhdhata)
2.Patients Of Either Gender
3.Patient Diagnosed With Anti CCP Positive |
|
| ExclusionCriteria |
| Details |
1.Other Inflammatory Disease eg-Lupus or Psoratic Arthritis
2.Significant Comorbidities eg-Severe Liver or Kidney Disease
3.Pregnancy or Lactating Women
4.Recent Infection
5.Certain Medication eg-Immunosupressant
6.Allergic And Sensitivities
7.Patient Having Disabilities Arthritis,Patient Having Permanent Deformity will Not Be Chosen
8.Choronicity of Disease More Than 10 Years
9.Patients Taking Regular Steriods ,Anti inflammatory Drugs And Methotrexate
10.Sweden Ayogya As Per Ayurveda Text |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To Assess The Effect Of Kanji Yukta Patrapottali In Reducing Pain ,Swelling,Stiffness In Amavata |
Baseline, Day 7,Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyse The Effect Of Treatment Using Standard Tool Like DAS28 Score |
Baseline,Day 7 |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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
|
Title- A Comparative Clinical Study Of Kanji Yukta Patrapottali And Kanji Dhara In The Pain Management Of Amavata w.s.r. To Rhuematoid Arthritis
Objective - 1.To Assess The Effect Of Kanji Yukta Patrapottali In Reducing Pain,Swelling And Stiffness In Amavata. 2. To Compare The Effect Of Kanji Yukta Patrapottali And Kanji Dhara In The Pain Management Of Amavata.
Groups- Group A - Trial Group - Kanji Yukta Patrapottali Group B- Control Group -Kanji Dhara
Duration Of Procedure -7 Days
Name Of Student- Dr. Monali Prakash Keni Name Of Guide - Dr Kalpana Gholap Dhomse |