| CTRI Number |
CTRI/2026/02/104319 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain management of frozen shoulder by Agnikarma |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The Effect Of Conduction Method Of Agnikarma With Panchaloha Shalaka And Swarna Shalaka In The Pain 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 |
Dr Midun S Kumar |
| Designation |
PG Scholar |
| Affiliation |
BVVS AMCH BAGALKOT |
| Address |
Department of PG studies in Shalya Tantra Room Number 3
BVVS Ayurved Medical College and Hospital Bagalkot Karnataka
Department of Shalya Tantra Room No 3
BVVS Ayurved Medical College and Hospital
BVVS Campus Old Busstand road Bagalkot Karnataka
Bagalkot KARNATAKA 587101 India |
| Phone |
9489668211 |
| Fax |
|
| Email |
drmidunsk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS AMCH BAGALKOT |
| Address |
C/o V S Karant
Plot No 41 E 55 sector
Navanagar Bagalkot Department of Shalya Tantra Room No 3
BVVS Ayurved Medical College and Hospital
BVVS Campus Old Busstand road Bagalkot Karnataka Bagalkot KARNATAKA 587102 India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr M S Hiremath |
| Designation |
Principal Professor |
| Affiliation |
BVVS AMCH BAGALKOT |
| Address |
Principal Office
BVVS Ayurved Medical College and Hospital
BVVS Campus Old Busstand road Bagalkot Karnataka Principal office
BVVS Ayurved Medical College and Hospital
BVVS Campus Old Busstand road Bagalkot Karnataka Bagalkot KARNATAKA 587101 India |
| Phone |
9482631399 |
| Fax |
|
| Email |
malikdost4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Bhargava Gold and diamonds uchakkada Trivandrum 695506 |
|
|
Primary Sponsor
|
| Name |
Dr Midun S Kumar |
| Address |
Department of PG studies in Shalya Tantra BVVS Ayurved Medical College and Hospital Bagalkot Karnataka India 587101
|
| Type of Sponsor |
Other [Self Sponsorship] |
|
|
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 Midun S Kumar |
BVVS Ayurved Medical College ana Hospital |
BVVS Ayurved Hospital Department of Shalya Tantra Room no 3
BVVS Campus Old Busstand road Bagalkot Karnataka India 587101 Bagalkot KARNATAKA |
9489668211
drmidunsk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVVS Ayurved Medical College and Hospital Bagalkot Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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|
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 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म with Swarna Shalaka | (Procedure Reference: SUSRUTHA SAMHITHA, Procedure details: Procedure of Agnikarma in Stantard Group: The procedure will be performed once daily over 7 consecutive days in stantard group. a) Purva Karma Informed written consent will be taken. Patients will be comfortably positioned. Abhyanga will be carried over shoulder region with Moorchitha Tila Taila. The most tender point will be marked with a marker. 10 b) Pradhana Karma One end of Swarna Shalaka (Stantard group)is placed on the marked point perpendicular to surface. The other end will be heated, with candle, heat will be transferred slowly from heating end to the other end which is in contact with the patient. This procedure will be performed untill the patient confirms he/she feels the heat. c) Paschat Karma Ghritakumari will be applied on the site of Agnikarma))
| | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म with Panchaloha Shalaka | (Procedure Reference: SUSRUTHA SAMHITHA, Procedure details: Procedure of Agnikarma in Study Group: The procedure will be performed once daily over 7 consecutive days in study group. a) Purva Karma Informed written consent will be taken. Patients will be comfortably positioned. Abhyanga will be carried over shoulder region with Moorchitha Tila Taila. The most tender point will be marked with a marker. 10 b) Pradhana Karma One end of Panchaloha Shalaka (Study group)is placed on the marked point perpendicular to surface. The other end will be heated, with candle, heat will be transferred slowly from heating end to the other end which is in contact with the patient. This procedure will be performed untill the patient confirms he/she feels the heat. c) Paschat Karma Ghritakumari will be applied on the site of Agnikarma))
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Avabahuka (Frozen Shoulder).
Patients of either gender and between the age group of 20 to 70 years.
Patients providing signed informed consent and expressing willingness to undergo the proposed treatment |
|
| ExclusionCriteria |
| Details |
Recent history of fractures, dislocation and traumatic injuries of Shoulder Joint.
Pregnant Women and Lactating Women.
Patients with uncontrolled diabetes mellitus or hypertension |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain
Reduction in stiffness |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improve Range of movement
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2026 |
| 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
|
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Brief Summary
|
Avabahuka is mentioned as one among the Vataja Nanatmaja Vyadhi by Acharya Sharangadhara. It affects the normal functioning of upper limbs, which in turn causes much inconvenience to normal routine lifestyle of an individual. The prevalence of Frozen shoulder in the general population is reported to be 2% and prevalence of 11% in unselected individuals with diabetes. It is peak in the age group of 40-60 years and is more common in women. Avabahuka is caused mainly by the Vyana Vata vitiation and gets Sthana Samshraya in the Amsa Pradesha. There it does the Shoshana of Shleshaka Kapha, Mamsa, Sira and Snayu, leading to Bahupraspanditaharatwam (restricted movement of affected shoulder) due to Stambha (stiffness) in Amsa Pradesha and Shoola (pain). These clinical features closely resemble with painful stiffness and loss of motion of shoulder. Hence it can be correlated with Frozen Shoulder as described in modern system of medicine. Frozen Shoulder is an idiopathic condition which manifests clinically as shoulder pain with progressive restricted movement, both active and passive along with normal radiographic scans of glenohumeral joint. It can affect activities like eating, dressing, personal hygiene and other works. Thus, life of such a patient becomes miserable. It can also disrupt sleep and reduce the overall quality of life due to persistent discomfort and stiffness. In modern science, treatment modalities like analgesics, local intra articular injections of corticosteroids in glenohumeral joint followed by physiotherapy are adopted. Treatment of Avabahuka includes Snehana and Nasya. In the pathological process of Avabahuka, Vatavridhi occurs, which does Shoshana of Sthanika Kapha which leads to the features of Sandhigatavata. Agnikarma is one among the para- surgical procedures and is the most effective intervention in the management of painful conditions, especially musculoskeletal disorders. Our classics have mentioned Agnikarma in Sira, Snayu, Sandhi, Asthi Gata Vata with Ugra Ruja. In Agnikarma burn with special tools is done on specific sites. Different Dahanopakaranas have been mentioned by Acharyas such as Pippali, Godanta, Shalaka etc. and is indicated for Twak, Mamsa, Sira, Snayu, Asthi and Sandhigata Vyadhi. Agni being Ushna act against the qualities of Vata and Kapha doshas, hence Agnikarma has curative effects on Vataja and Kaphaja disorders, according to Acharya Dalhana. Agnikarma increases local Dhatwagni and thus helps curing diseases as well as reducing the chance of recurrence. Agnikarma will be carried out with the help of Panchaloha Shalaka and Swarna Shalaka. Panchaloha Shalaka will be made up of Kamsya, Tamra, Pithala, Loha, Naga, in 1:1:1:1:1 ratio11. The Shalaka prepared by combination of these Panchaloha retains heat for longer period. This facilitates proper Agnikarma and desired effects are obtained. Acharya Dalhana mentions Swarna to be one among the superior metal for the manufacturing of Yantras. Gold remains conductive for a longer time as compared to copper and silver, also gold does not corrode. Hence, an effort is made to evaluate the effect of conduction method of Agnikarma with Panchaloha Shalaka and Swarna Shalaka in the pain management of Avabahuka with special reference to Frozen Shoulder.
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