| CTRI Number |
CTRI/2026/02/104167 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to evaluate effect of Agnikarma with honey in Frozen shoulder |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the effect of Agnikarma with Madhu in the management of Avabahuka |
| 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 Prachi Madhukarrao Bhole |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalya And Rugnalya |
| Address |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Chhatrapati Sambhajinagar Department of Shalyatantra OPD No 16
Kanchanwadi , Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8411857241 |
| Fax |
|
| Email |
prachibhole22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Nivruttirao Gundre |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalya And Rugnalya |
| Address |
CSMSS Ayurved Mahavidyalya And Rugnalya Chhatrapati Sambhajinagar Department of Shalyatantra OPD No 16
Kanchanwadi , Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9518548733 |
| Fax |
|
| Email |
rgundre200@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Madhukarrao Bhole |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalya And Rugnalya |
| Address |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Chhatrapati Sambhajinagar Department of Shalyatantra OPD No 16
Kanchanwadi , Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8411857241 |
| Fax |
|
| Email |
prachibhole22@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalya And Rugnalya , Kanchanwadi , Chhatrapati Sambhajinagar,Maharashtra 431011 |
|
|
Primary Sponsor
|
| Name |
Dr Prachi Madhukarrao Bhole |
| Address |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Chhatrapati Sambhajinagar Department of Shalyatantra OPD No 16
Kanchanwadi , Chhatrapati Sambhajinagar |
| 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 Prachi Madhukarrao Bhole |
CSMSS Ayurved Mahavidyalya And Rugnalya |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Chhatrapati Sambhajinagar Department of Shalyatantra OPD No 16
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA |
08411857241
prachibhole22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidyalay Chhatrapati Sambhajinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut sutra 12, Procedure details: 1.Purva karma:
1. The patients will be explained about the procedure.
2. Written consent will be taken from every patient .
3. The position will be depending upon pain site and comfort.
4. The shoulder region will be cleaned with an antiseptic solution &
allowed to dry.
5.The area of maximum tenderness will be palpated & marked.
2.Pradhana karma:
1.Madhu (Honey) will be taken & heated over the gas burner till frothing.
2. Then ,with the help of a glass pipette, Madhu was poured in a drop -wise manner on the marked points(where maximum tenderness felt)
3.Paschat karma:
1. Ghruta will be applied as a cooling agent.
)
(1) Medicine Name: madhu, Reference: sushrut sutra 12, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Avabahuka
Selection will be irrespective of sex religion and socioeconomic status
Agnikarma yogya rogi |
|
| ExclusionCriteria |
| Details |
Subluxations or recurrent dislocations of the shoulder joint
Patients suffering from rotator cuff injuries other diseases like paralysis pregnant women
Agnikarma ayogya rogi |
|
|
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 |
| Pain and Stiffness is decreased and Range of Motion is increased |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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 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
|
Avabahuka is one such disease that hampers the routine activity of
an individual to carry out daily activities such as routine work , personal
hygiene, eating, dressing . Among the Doshas, Vata Dosha is superior in
all aspects, strong in its ability and activity. Vata disorders occupy top
most position in the field of pathological condition due to faulty life
style.
The frozen shoulder is characterised by gradually progressive,
painful restricted movements of shoulder joint (particularly internal
rotation and abduction),(rendering the patient unable to sleep on the
affected side).
The study will be conducted on 60 diagnosed patients of avabahuka i.e. frozen shoulder
Screening of patients for inclusion
Initial assesment for patient selection
Informed written consent
Randomization and group allocation
Trial group(A)-30 patients-Agnikarma with madhu
Control group(B)-30 patients -Agnikarma with loha shalaka
Follow up for assesment(maximum 14 days)
Observation and results will be noted
Statistical analysis
Discussion and conclusion |