| CTRI Number |
CTRI/2026/01/102465 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Other (Specify) [Procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of two Ayurvedic heat treatments to improve pain and shoulder movement in Frozen shoulder. |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study To Evaluate The Effect Of Gudagnikarma With Tamrashalaka Agnikarma In The Management Of Avabahuka With Special Reference To 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 |
Dayasagar Balajirao Jadhav |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Hospital , Sangamner |
| Address |
Shalyatantra OPD Number 6,Siddhakala Ayurved Mahavidyalaya and hospital Sangamner khurd, Pimparane Road, Sangamner, Ahmednagar, 422605
Shalyatantra OPD Number 6, Siddhakala Ayurved Mahavidyalaya and hospital Sangamner khurd, Pimparane road, Sangamner, Ahmednagar, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7263066920 |
| Fax |
|
| Email |
dayahalikar122421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish Kishor Saraf |
| Designation |
Head Of Department Of Shalyatantra |
| Affiliation |
Siddhakala Ayurveda Hospital , Sangamner |
| Address |
Siddhakala Ayurveda Mahavidyalaya , Sangamner , Siddhakala Ayurveda Hospital, Pimparane Road, Sangamner khurd , Sangamner , Ahmednagar -422605
Siddhakala Ayurveda Mahavidyalaya , Sangamner , Siddhakala Ayurveda Hospital, Pimparane Road, Sangamner khurd , Sangamner , Ahmednagar -422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dayasagar Balajirao Jadhav |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Hospital , Sangamner |
| Address |
Shalyatantra OPD Number 6,Siddhakala Ayurveda Mahavidyalaya and hospital, Sangamner khurd , Pimparane Road, Sangamner , Ahmednagar 422605
Shalyatantra OPD Number 6, Siddhakala Ayurved Mahavidyalaya and hospital, Sangamner khurd,Pimparane road, sangamner, Ahmednagar,422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7263066920 |
| Fax |
|
| Email |
dayahalikar122421@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurveda Mahavidyalaya And Research Centre, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar,Maharashtra, India, Pincode -422605 |
|
|
Primary Sponsor
|
| Name |
Dr Dayasagar Balajirao Jadhav |
| Address |
Siddhakala Ayurveda Mahavidyalaya And Research Centre, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar,Maharashtra, India, Pincode -422605 |
| 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 Dayasagar Balajirao Jadhav |
Siddhakala Ayurveda Mahavidyalaya And Hospital, Pimparne Road, Sangamner |
Shalyatantra OPD Number 6,Siddhakala Ayurveda Mahavidyalaya , Sangamner , Siddhakala Ayurveda Hospital, Pimparane Road, Sangamner khurd , Sangamner , Ahmednagar -422605
Ahmadnagar
MAHARASHTRA |
7263066920
dayahalikar122421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board Of Research And Statistics Committee Of Siddhakala Ayurveda Mahavidyalaya , Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Shushrut sutrasthan chapter 12, shloka no 4, Procedure details: •Pre-operative -Guda in small quantity is taken in a Sterile dish
•Operative – choose the most tender area of shoulder. The Guda is heated up to convert into a warmed molten form
•Apply hot Guda on most tender part with Bindu pattern up to 2-5 seconds
•Samyak dagdha lakshana mark the appropriate signs of agnikarma
•Applied Guda will not be removed instantly.
•If any bleb or ulcer developed at the site of Agnikarma Madhu Sarpi can be applied for healing.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Ashtanghruday, Procedure details: •Pre-operative- Clean the affected area with normal water.
•Operative - Choose the most tender area of shoulder. The Tamra Shalaka is heated till red hot.
•Pre heated Tamra shalaka is applied on the most tender part of shoulder in Bindu pattern (direct heat method).
•Samyak dagdha lakshana marks the appropriateness of the agnikarma done.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical Sign and Symptoms of Avabahuka, freezing & frozen stage frozen shoulder.
2. Patient aged 18-70 yrs.
3. Patient shall be irrespective of gender, religion, socio-economical class.
4.Controlled diabetes mellitus taking regular antidiabetic medicines |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled Diabetes
2. H.I.V, HbsAg Known case
3. History of trauma to shoulder joint.
4. Pregnancy
5.Thawing (Recovery) stage of frozen shoulder
6. Known case of shoulder pain or restricted movements other than frozen shoulder such as Fracture, Tear, cervical spondylosis, Myocardial ischemia, Arthritis, Dislocation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the comparative effect of Gudanikarma and Tamra shalaka Agnikarma in the management of Avabahuka with special reference to Frozen Shoulder with respect to pain, stiffness and associated symptoms. |
0th Day (Baseline Assessesment) , 3rd day (follow up),5th day (follow up) 7th Day (Final Assessesment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To prepare or standardize SOP for Gudaagnikarma.
2) To evaluate effect on other associated symptoms
3) To study adverse effect if any |
0th Day , 3rd Day , 5th Day , 7th Day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/02/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is Randomized Open Labelled Comparative Clinical Trial Comparing Safety And Efficacy Of Gudagnikarma With Tamrashalaka Agnikarma For 7 Days In 60 Patients Of Avabahuka In Two Groups And Observed VAS-NRS Scale And Goniometer Score . |