| CTRI Number |
CTRI/2025/03/082776 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Other (Specify) [Procedure] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical Study for assessing the effectiveness of Angamardana using ksheerabala taila in treating Frozen shoulder . |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Angamardana with Ksheerabala Taila in the management of Apabahuka W.S.R 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 Apoorva B N |
| Designation |
P.G.Scholar |
| Affiliation |
K.V.G Ayurveda Medical College and Hospital |
| Address |
Room No-1 Panchakarma OPD , K.V.G Ayurveda Medical College and Hospital, Ambateadka, Krunjibhag, Jattipalla, Sullia .
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9008108232 |
| Fax |
|
| Email |
apoorvabn02@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanath Kumar D G |
| Designation |
Professor and HOD |
| Affiliation |
K.V.G Ayurveda Medical College and Hospital |
| Address |
Room No-1 Panchakarma OPD , K.V.G Ayurveda Medical College and Hospital, Ambateadka, Krunjibhag, Jattipalla, Sullia .
Dakshina Kannada KARNATAKA 574237 India |
| Phone |
9448152543 |
| Fax |
|
| Email |
sanathdg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanath Kumar D G |
| Designation |
Professor and HOD |
| Affiliation |
K.V.G Ayurveda Medical College and Hospital |
| Address |
Room No-1 Panchakarma OPD , K.V.G Ayurveda Medical College and Hospital, Ambateadka, Krunjibhag, Jattipalla, Sullia .
Dakshina Kannada KARNATAKA 574237 India |
| Phone |
9448152543 |
| Fax |
|
| Email |
sanathdg@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Ayurveda medical college and Hospital
Ambate Adka Kurunjibag
Sullia
Dakshina Kannada district
Karnataka State
India
574327 |
|
|
Primary Sponsor
|
| Name |
Dr Apoorva B N |
| Address |
PG Scholar, Department of Panchakarma
K.V.G Ayurveda Medical College and Hospital , Ambate adka , Kurunjibhag, Jattipalla , Sullia, 574327 |
| 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 APOORVA B N |
K.V.G AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Department of Panchakarma
Room No-1
Ambate Adka, Kurunjibag, Sullia 574327
Dakshina Kannada KARNATAKA |
9008108232
apoorvabn02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurveda Medical college Ethics committee |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical Lakshana of Apabahuka and symptoms of Frozen shoulder.
Patients of both gender who are Mardana yogya /Abhyanga according to Ayurveda classics irrespective of occupation and Socio economic Individuals between 18 to 70 years of age.
|
|
| ExclusionCriteria |
| Details |
Patients with the history of fracture, dislocation of shoulder joint.
Patients who are Mardana ayogya / Abhyanga according to ayurveda classics.
Patients below 18 years and above 70 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain and stiffness
Improvement in the shoulder joint range of movements that are assessed through
1. VAS Scale scoring -pain assessment.
2. SPADI Score for shoulder pain and disability function assessement. |
Before treatment on(0th day)
7th day of the treatment.
14th day Follow Up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0" 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
|
Many of the diseases in the present era are not life threatening, but adversely affecting day to day activities. At present, pain in the shoulder joint and arm has significantly increased in the general population due to improper lifestyle choices and food habits. Apabahuka is a disease caused by Vata dosha which effects Amsa Sandhi and does Shoshana of Shleshaka Kapha, Mamsa, Sira, Snayu which in turns leads to Bahupraspanditahara ,Shoola and Sthamba,due to which patient is unable to lift the arm . Apabahuka can be correlated to Frozen shoulder or adhesive capsulitis present with pain associated with marked restriction of elevation and external roatation. Contemporary treatment in the early stage is with analgesics , intra-and extracapsular glucocorticoid injections and regular ‘pendulum exercises’of the arm to mobilise .This promises a temporary relief but when symptoms aggravate, people tend to search other modalities of treatment due to incapability of the drugs to give permanent relief. Therefore there is need for research in other non-invasive procedure which is cost effective and has better efficacy comparatively . Ayurveda literature explains different treatments like Nasya, Uttarabhaktika Snehapana and Snehana in the management of Apabahuka. The word Snehana indicates both Bahya and Abhyantara Sneha. Bahya Sneha can be administered in the form of Abhyanaga. Abhyanga done with pressure is termed as ‘‘Mardana’’. Acharya Tiruka in his work ‘‘Angamardana’’explains mardana techniques in different regions of the body . These are termed as Hastas. There are total 26 Hastas mentioned in Angamardana for different parts of the body, among them Vijayamala hasta , Vipareeta vijayamala Hasta , Shaila Hasta, Dheera Hasta , Chakra Hasta , Vipareeta Chakra Hasta and Taranga Hasta for Neck , Shoulder , and Arm respectively . These Hastas helps to perform Mardana systematically . Ksheerabala Taila is having vatahara property and Indicated in all Vatavyadhi. Hence this study is taken to evaluate the efficacy of Angamardana in Apabahuka with Ksheerabala taila . |