| CTRI Number |
CTRI/2025/03/082821 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of sandhana kara lepa in ankle sprain |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of sandhana kara lepa in 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 KONDURU SREEJA |
| Designation |
PG scholar |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA
524107
India |
| Phone |
9176239728 |
| Fax |
|
| Email |
sreejakonduru0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saiprasad S Shettigar |
| Designation |
Associate professor |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8277766651 |
| Fax |
|
| Email |
eastwestpack@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Konduru Sreeja |
| Designation |
PG scholar |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9176239728 |
| Fax |
|
| Email |
sreejakonduru0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, Udupi - 576104
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Konduru Sreeja |
Muniyal institute of ayurveda medical sciences, Manipal |
Outpatient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA |
9176239728
sreejakonduru0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal institute of ayurveda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: SNAYUMARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Susrutha Samhitha Sutra Stana 18th Chapter 12th sloka, Procedure details: Ardhramaheesha Charmavat (0.25cms) Sandhana Kara Lepa will be applied to the
patient using warm water, wrapped with a plastic cover & Bandhana will be done using Crepe Bandage
once a day & will be retained for 24 hours for 15 days.)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Susrutha Samhitha Sutra Stana 18th chapter 12th sloka, Procedure details: Ardhramaheesha Charmavat (0.25cms) Marma Gutika Lepa will be applied to the
patient using warm water, wrapped with a plastic cover & Bandhana will be done using Crepe Bandage
once a day & will be retained for 24 hours for 15 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-50 years.
2.Patients belong to any gender will be included.
3.Subjects with grade-1 and grade-2 ankle sprains. |
|
| ExclusionCriteria |
| Details |
1.Subjects with grade - 3 ankle sprain
2.Subjects with fracture & dislocation of the ankle joint.
3.Subjects with previous history of ligament or bony reconstructive surgery to the ankle &
foot.
4.Subjects presenting with a wound over the ankle and a sprain will be excluded.
5.Subjects with other systemic illnesses like diabetes mellitus, etc.,
6.Pregnant ladies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain & swelling |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of swelling and restoration to normal movement |
21 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)
|
25/04/2025 |
| 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="4"
Days="20" |
|
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
|
Even though ankle sprains seem to be simple injuries, they are most painful and hinder the routine activities of the sufferer. It is characterized by pain, and swelling with or without deformity. Ankle sprains are present on either the medial or lateral side, but the most common is a lateral sprain. Twists in the ankle are frequent in sports leading to ankle pain. In allied science, the treatment principle is PRICER i.e., Pain killers, Rest, Ice Application, Compression and Elevation of foot & Rehabilitation. No direct explanation of sprain with its management in the classics. Acharya Sushruta while explaining Bhagna Chikitsa in the context of Asthi-Bhagna mentioned the word “Patanabhighatadwa”. Acharya Susrutha has mentioned Lepa as the 1st treatment for all types of swelling. The treatment modality that is less expensive, easy to administer with lesser complications & better rate of success should be the criteria in choosing the management of Ankle Sprain. In folklore practice, the traditional Vaidyas have many simple & effective remedies against many disorders & one such medicine is Sandhanakara lepa used in the treatment of Ankle Sprain. There is no direct reference for this lepa in our classics directly but the drugs used in this have been mentioned individually. Hence, a study will be carried out to study the efficacy of the Sandhanakara lepa in comparison with clinically established Marma Gutika lepa in Ankle Sprain. |