| CTRI Number |
CTRI/2025/04/085312 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study will test how well a traditional Ayurvedic oil treatment called Mahanarayana Taila Seka and a special ankle bandage known as Swastika Bandhana work together to treat ankle sprains, helping to reduce pain and swelling, support the ankle, and improve movement during healing. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the combined efficacy
Of Mahanarayana Taila Seka and Swastika Bandhana in Gulpha
Marmaghata vis-à-vis ankle sprain
|
| 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 Shashanka Parameshwara Bhat P |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ayurveda Mahavidyalaya And Hospital, Hubballi |
| Address |
Ayurveda Mahavidyalaya And Hospital Heggeri Extension Hubballi 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9481467664 |
| Fax |
|
| Email |
drshashankpbhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddanagouda A Patil |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubballi |
| Address |
Dept Of Shalya Tantra
Ayurveda Mahavidyalaya And Hospital Heggeri Extension Hubballi 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9448565198 |
| Fax |
|
| Email |
drsapatilms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddanagouda A Patil |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital Hubballi |
| Address |
Dept Of Shalya Tantra
Ayurveda Mahavidyalaya And Hospital Heggeri Extension Hubballi 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9448565198 |
| Fax |
|
| Email |
drsapatilms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya and Hospital, Heggeri, Hubballi
580024 |
|
|
Primary Sponsor
|
| Name |
Dr Shashanka Parameshwara Bhat P |
| Address |
H No 11/44 G
C/O Subrahmanya Bhat P
Swami Vivekananda Road
Kuthpady Udyavara
Udupi- 574118
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurveda Mahavidyalaya and Hospital Hubballi |
Ayurveda Mahavidyalaya and Hospital Heggeri Colony Hubballi - 580024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashanka Parameshwara Bhat P |
Ayurveda Mahavidyalaya and Hospital |
Department of Shalyatantra
Room no 16 and 17
Heggeri Colony Hubballi 580024
Dharwad
KARNATAKA |
9481467664
drshashankpbhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurveda Mahavidyalaya and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:S934||Sprain of ankle. Ayurveda Condition: GULPA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | snehanasekaH, स्नेहनसेकः | (Procedure Reference: Sushruta Samhita, Procedure details: Lukewarm sneha seka with Mahanarayana Taila followed by swasthika bandhana)
(1) Medicine Name: Mahanarayana Taila, Reference: Bhaishajya Ratnavalli, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 12 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Grade I and Grade II clinical features of Ankle Sprain.
Subject presenting clinical features of Gulpha Marmaghata/Ankle sprain.
|
|
| ExclusionCriteria |
| Details |
Patients with fracture, dislocation, and open wound of Ankle joint.
Patients with H/O ligament bony reconstructive surgery to ankle and foot.
Grade III ankle sprain |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain reduction before and after outcome
|
Assessed on 0th, 3rd , 6th, 9th, and 12th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in range of movements
|
Assessed on 0th, 3rd , 6th, 9th, and 12th day |
Reduction in swelling
|
Assessed on 0th, 3rd , 6th, 9th, and 12th day |
Reduction in tenderness
|
Assessed on 0th, 3rd , 6th, 9th, and 12th day |
|
|
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)
|
27/04/2025 |
| 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="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
|
This study aims to evaluate the combined efficacy of Mahanarayana Taila Seka and Swastika Bandhana in the management of Gulpha Marmaghata, which can be correlated to ankle sprains in modern medicine. The ankle joint, vital for mobility, is prone to sprains due to sudden twisting or rolling, causing ligament injuries. While ankle sprains are common, especially in women and children, they often lead to pain, swelling, and instability. Current treatments, including RICE and anti-inflammatory medications, offer temporary relief but lack long-term healing properties. Traditional Ayurvedic treatments, including Mahanarayana Taila Seka and Swastika Bandhana, have shown potential in promoting faster healing by addressing the underlying cause of ligament injury. The study aims to critically analyze the literature on Gulpha Marmaghata and ankle sprains, while assessing the effectiveness of these Ayurvedic therapies in comparison to modern treatment protocols. The hypothesis proposes that the combined approach significantly improves healing and recovery in ankle sprain cases. |