| CTRI Number |
CTRI/2025/09/094033 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Procedure- Massage , marma point stimulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study comparing the effect of marma abhyanga (therapeutic oil massage )alone versus marma abhyanga with varma manipulation (marma point therapy) in the management of frozen shoulder |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of marma abhyanga versus marma abhyanga with varma manipulation in the management of avabahuka 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.N.S.Vandana Dhanalakshmi |
| Designation |
Post graduate scholar |
| Affiliation |
Sdm College of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi |
| Address |
Sdm College of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi
Shalyatantra general opd nnumber 5,opd number 4
PIN-574118
Udupi
KARNATAKA
574118
India |
| Phone |
9074489835 |
| Fax |
|
| Email |
vandhu.ns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajneesh V Giri |
| Designation |
Head of the Department, Department of Shalyatantra, SDM Udupi |
| Affiliation |
Sdm College of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi |
| Address |
Sdm College of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi
Shalyatantra general opd number 5,opd number 4
PIN-574118
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.N.S.Vandana Dhanalakshmi |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sdm College of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi |
| Address |
Sdm College of Ayurveda,Hospital and Research Centre,Kuthpady,Udupi
Shalyatantra general opd number 5,opd number 4
PIN-574118
Udupi
KARNATAKA
574118
India |
| Phone |
9074489835 |
| Fax |
|
| Email |
vandhu.ns@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda, Hospital and Research Centre Kuthpady Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre, Kuthpady, Udupi,
Karnataka, India, 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrNSVandana Dhanalakshmi |
SDM College of Ayurveda,Hospital and Research Centre |
Department of Shalyatantra,
Shalyatantra General OPD number 4 and 5
SDM College of Ayurveda, Hospital and Research Centre
Kuthpady
Udupi
PIN- 574118
Udupi
KARNATAKA |
9074489835
-
vandhu.ns@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee, SDM Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M759||Shoulder lesion, unspecified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: -, Procedure details: Varma manipulation followed by Marma abhyanga with Parinatakeriksheeradi thaila for 5 minutes,once a day for 7 days)
(1) Medicine Name: Parinatakeriksheeradi thaila , Reference: sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Prasarinyadi kashaya, Reference: sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 2 Weeks | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: -, Procedure details: Marma Abhyanga with Parinatakeriksheeradithaila q.s for 5 minutes once a day for 7 days)
(1) Medicine Name: Prasarinyadi kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 2 Weeks(2) Medicine Name: Parinatakeriksheeradithaila, Reference: Sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Avabahuka according to classical signs and symptoms.
2. Patients of both sexes within the age group of 18-70 years.
3. Patients with informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from SLE, RA, CA, ALS, PLS.
2. Cervical spondylitis, radiating pain to upper limb
3. Patients with elbow, wrist and hand conditions.
4. Patients with open wounds, skin lesions in upper limb and shoulder region.
5. Patients who have undergone major shoulder surgeries.
6. Patients below 18 years of age and above 70 years.
7. Patients suffering from acute shoulder injury. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the role of Marma Abhyanga in the management of Avabahuka and the add-on effect of Varma manipulation with Marma Abhyanga in the management of
Avabahuka.
To compare the results of Marma abhyanga and Varma manipulation with Marma Abhyanga in the
management of Avabahuka. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shoulder Pain and Disability Index (SPADI) ,
Range of Joint Movement (using Goniometer)
Tenderness |
30 days |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
12/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/09/2025 |
| 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) |
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
|
Frozen shoulder is a condition characterized by pain, stiffness and restricted range of motion of the
shoulder joint, significantly impacting an individual’s ability to perform daily activities. The incidence rate
is 3-5% globally and 38% among the diabetic population2 insinuating its significant socioeconomic impact.
Conventional treatments involve medications like NSAIDs, physiotherapy, intra-articular injections, and in
severe cases, surgeries. Despite these interventions, recurrence post-management remains a challenge.
Avabahuka is a Vatavyadhi which affects the Amsa Sandhi causing Baahupraspanditahara and Vedana, the
clinical presentation comparable to that of Frozen Shoulder. Ayurveda offers several modalities that provide
comprehensive relief for Avabahuka, among which Marma Chikitsa stands as a lesser-known option.
Marma Chikitsa, encompassing indigenous yet efficient practices such as Keraliya Marma Abhyanga
Bandhana Vidhi and Tamil Siddha Varma Shastra, presents a promising avenue for addressing Avabahuka.
However, empirical evidence supporting Marma Chikitsa’s efficacy for Avabahuka remains scant.
Therefore, this study aims to rigorously evaluate the therapeutic potential of Marma Chikitsa to address the
persistent demand for safer and more efficacious interventions. |