| CTRI Number |
CTRI/2022/07/043783 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare effect of two tailas used for bandaging,saksheerasidha balataila and murivenna in patients with acute ligament injuries of ankle joint- Grade I and II |
|
Scientific Title of Study
|
Comparative clinical trial on the effect of bandage with saksheerasidha balataila against murivenna in acute ligament injuries of ankle joint- Grade I and II |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renuka K Raman |
| Designation |
PG Student |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Renuka K Raman,
PG Student,
Department of Salyatantra,
Government Ayurveda College Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9605500682 |
| Fax |
|
| Email |
renukaraman333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M M Abdul Shukkoor |
| Designation |
Professor and Head Of the Department |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Dr M M Abdul Shukkoor,
Professor and Head Of the Department,
Department Of Salyatantra,
Government Ayurveda College,
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9447661001 |
| Fax |
|
| Email |
drsukoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M M Abdul Shukkoor |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Dr M M Abdul Shukkoor,
Professor and Head Of the Department,
Department Of Salyatantra,
Government Ayurveda College,
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9447661001 |
| Fax |
|
| Email |
drsukoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Tripunithura |
| Address |
Government Ayurveda College Tripunithura, Ernakulam District, Pin : 682301 |
| Type of Sponsor |
Other [Government Ayurveda College] |
|
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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 |
| Renuka K Raman |
Government Ayurveda College Hospital Tripunithura |
OP No. 4, Government Ayurveda College Hospital Tripunithura,
Ernakulam District, Pin : 682301
Ernakulam
KERALA |
9605500682
renukaraman333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee For Ethics in Research |
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:S934||Sprain of ankle. Ayurveda Condition: UTPISHTA-SANDHIMUKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bandhanakarma, बनà¥à¤§à¤¨à¤•à¤°à¥à¤® | (Procedure Reference: BANDHANA KARMA IN SUSRUTA SAMHITA, Procedure details: Affected leg is extended and the foot will be dorsiflexed. Gauze and cotton pad will be applied over the area followed which sakhseerasidha balataila poured over the area. Later, Kora cloth of dimension 3 M to 10 cm will be used for swasthika kind of bandage.)
(1) Medicine Name: SAKSHEERASIDHA BALATAILA, Reference: YOGAMRUTHAM, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | bandhanakarma, बनà¥à¤§à¤¨à¤•à¤°à¥à¤® | (Procedure Reference: BANDHANA KARMA IN SUSRUTA SAMHITA, Procedure details: Affected leg is extended and the foot will be dorsiflexed. Gauze and cotton pad will be applied over the area followed which murivenna poured over the area. Later, Kora cloth of dimension 3 M to 10 cm will be used for swasthika kind of bandage.)
(1) Medicine Name: MURIVENNA, Reference: AFI, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female participants in the age group of 18 years to 50 years will be enrolled.
2. Participants who are diagnosed with acute ligament injuries of ankle joint-Grade I and II by clinical examination
3. Participants with written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Participants with less than 18 years and above 50 years of age will be excluded.
2. Participants with fractures, dislocation and open wounds in and around ankle and foot.
3. Associated with Achilles tendon rupture.
4. Known case of tuberculosis of ankle joint and uncontrolled diabetes |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tenderness : Reduction in tenderness assessed by grading.
Pain : Reduction in pain assessed by grading.
Swelling : Reduction in swelling by measuring size of ankle joint.
Ankle function: Increase the range of movement by assessing in goninometer in degree.
|
Each subject will be managed with a treatment period for 14 days.
Assessement will be done on 0th,7th,14th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
09/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/07/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial will be conducted to assess the effect of Saksheerasidha balataila, mentioned in Yogamrutham for bandaging in Acute ligament injuries of ankle joint Grade I and II and compare it with Murivenna bandage .The study will be conducted in participants who are clinically diagnosed with acute ligament injuries of ankle joint Grade I and II attending the OP and IP, Department of Salyatantra ,Government Ayurveda College Tripunithura, in the age group 18 to 50 years, who satisfy the inclusion and exclusion critera. The study duration is 14 days. Primary outcomes are pain , tenderness ,swelling and ankle function. Pain and tenderness is assessed by grading, swelling is assessed by measuring the size of ankle joint and ankle function is assessed by increase in the range of movements using goniometer in degree. Assessment will be done on 0th day, 7th day and 14th day. |