| CTRI Number |
CTRI/2025/08/093297 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To see and Compare efficacy of Agnikarma (Heat Therapy),Jalauka Avacharna (Leech Therapy) and Cupping Therapy for Frozen Shoulder |
|
Scientific Title of Study
|
A Triple Arm Open Label Randomized Controlled
Comparative Clinical Trial To Evaluate The Efficacy Of Agni Karma, Jalauka Avacharana And
Cupping Therapy In The Management Of Avabahuka [Frozen Shoulder |
| 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 Naveen Kumar |
| Designation |
M D Panchkarma scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room NO. 29 1st floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Umri Road, Sector 8,Kurukshetra, Haryana – 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
8929404551 |
| Fax |
|
| Email |
nk73573@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashish Mehta |
| Designation |
Professor & Chairperson of PG Department of Panchkarma |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room NO. 67 1st floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Umri Road, Sector 8,Kurukshetra, Haryana – 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Kumar |
| Designation |
M D Panchkarma scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room NO. 29 1st floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Umri Road, Sector 8,Kurukshetra, Haryana – 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
8929404551 |
| Fax |
|
| Email |
nk73573@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies & Research Shri Krishna AYUSH University |
| Address |
Sector 8 Umri Road Kurukshetra 136118 Haryana 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 Naveen Kumar |
Institute for Ayurved Studies and Research ,Shri Krishna AYUSH University Kurukshetra |
Room no. 29 First Floor Institute for Ayurved Studies and Research ,Shri Krishna Government Ayurvedic Hospital Umri Road sec. 8 Kurukshetra
Kurukshetra
HARYANA |
8929404551
nk73573@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Wet cupping Therapy | (Procedure Reference: Sushruta Samhita Sutra Sthana Chapter 13, Procedure details: Prachhan Karma (small superficial incision) as describe in Ayurveda text, when drop of blood ooze out then apply cup by using suction pump to create vaccum.Leave it for 5-15 minute based on the purposeful bloodletting.Remove the cup gently & clean the area with a proper antiseptic /4 sitting at interval of 7 day & follow up for 2 week after trial )
| | 2 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushruta Samhita Sutra Sthana Chapter 13, Procedure details: Medicated Leeches has to attach properly to area of skin affected in shoulder joint, when it attach properly it form a horseshoe shaped around its neck , then it need to be covered by thin wet cotton swab.Allow leech attachment for 45 minute & after that detach leech manually if it didn’t detach itself.Now clean the bite site thoroughly & apply turmeric powder / Jatyadi Ghrita & do mild bandage /4 sitting at interval of 7 day & follow up for 2 week after trial )
| | 3 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Reference: Sushruta Samhita Chikitsa Sthana Chapter 12, Procedure details: Bindu type of Agni Karma will be done by red hot Panchadhatu Shalaka till the Lakshana of Samyak Twakdagdha at the part of anterior-superior part of shoulder joint / 4 sitting at interval of 7 day & follow up for 2 week after trial)
|
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having the typical sign and symptoms of Avabahuka and Frozen shoulder between Age group of 30-50 years, of either gender.Patients willing to undergo trial.Patients suffering from controlled Diabetes Mellitus.Patient suitable for Agnikarma. Jalauka Avacharna and Cupping therapy.Patient had signed the consent form. |
|
| ExclusionCriteria |
| Details |
Age below 30 years and above 50 years,Suffering from specific arthritis like OA, RA etc.,Patients of shoulder joint fracture within last six months,Patients having any surgical procedure on shoulder joint in the last six months,Patients suffering from uncontrolled Diabetes Mellitus and hypertension, and localized skin
infection. HIV, Hepatitis, etc. Haematological diseases,Auto Immune disorder like SLE, RA etc.,Pregnant women and lactating mothers, Patient not suitable for Agnikarma, Jalauka Avacharna and Cupping therapy,Patient had not signed the consent form. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Proportion of patient showing improvement in the level of range of motion after trial. |
1st- 0 Day
2nd- After completion of Trial
3rd- 2 week after completion of follow up after trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the symptoms of patient sandhi shool (pain).
Reduction in the symptoms of patient stabadhta (stiffness).
Reduction in sandhi shosh.
|
1st- 0 Day
2nd- After completion of Trial
3rd- 2week after completion of follow up after trial |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
04/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this open-label, controlled comparative clinical trial, 45 patients with Avabahuka (frozen shoulder) will be enrolled after meeting the necessary criteria. In Group A, 15 patients would be treated with Bindu-type Agnikarma, an Ayurvedic procedure that uses a red-hot Panchadhatu Shalaka, in four sessions spaced 7 days apart. Group B would also have 15 patients, who would receive Jalauka Avacharana (Leech therapy) in four sessions, with the same 7-day intervals. In Group C, the last 15 patients will undergo Cupping Therapy , also over four sessions at 7-day intervals. Before starting the treatment, all patients would be tested for essensial investigation to ensure they meet the study’s requirements. The effectiveness of the treatments will be measured by looking at the range of motion (ROM) in the shoulder using a grading scale i.e. Gradiation of Motion of Shoulder Joint Scale and assessment of pain and disability with The Shoulder Pain and Disability Index (SPADI) scale. The ROM will be measured using a goniometer, while the SPADI will help to evaluate pain and disability by questionnaire. After the treatments, the results will be analyzed statistically. |