| CTRI Number |
CTRI/2025/04/086047 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Vishlista Bhagna of Gulpha Sandhi with Manjisthadi Lepa. |
|
Scientific Title of Study
|
Clinical Study on Vishlista Bhagna of Gulpha Sandhi and its management with Manjisthadi Lepa. |
| 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 Abhijeet Majhi |
| Designation |
MS Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Postgraduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
7609911209 |
| Fax |
|
| Email |
abhijeetmajhi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor & HOOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Postgraduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor & HOOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Postgraduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhijeet Majhi |
| Address |
Postgraduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri Odisha
India 752002 |
| 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 |
| Prof Dr Ranjan Kumar Kasta |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
OPD & IPD of Postgraduate Department of Shalyatantra
Puri Odisha 752002
Puri
ORISSA |
9439809240
drrkkasta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya & Hospital Puri Odisha 752002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:S934||Sprain of ankle. Ayurveda Condition: BAGNA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Alepa-karma, आलेप-कर्म | (Procedure Reference: SU CHI 3/7, Procedure details: BANDAGING OF VISLISHTA BHAGNA FOLLED BY MANJISTHADI LEPA.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Only cases of simple uncomplicated Vislista Bhagna of Gulpha Sandhi.
Patients with clinical features of sprain as pain, swelling, joint stiffness, loss of function
Patients between age group 18 to 60 years
Patients of first and second grade Ankle sprain |
|
| ExclusionCriteria |
| Details |
Patients with fracture and complete dislocation of joint
Patients with third grade sprain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To further more explore the anti inflammatory, healing and analgesic
properties of drugs involved in Manjisthadi Lepa.
2. To find out which is more effective between only crepe bandaging over
sprained area & crepe bandaging with Manjisthadi Lepa. |
Patients will be examined on initial day zero and further followed every week
for 3weeks to note the changes in signs and symptoms of the patients and also
to note whether the relief provided by the therapy is sustained or not or
whether there is any relapse. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in signs and symptoms of the patients will be assessed. |
Oth,7th,14th,21th respectively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/05/2025 |
| 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="0"
Months="1"
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
|
60 patients will be selected for the study out of which under Trial Group 1 30 patients will be treated with Crepe Bandage and under Trial Group 2 rest 30 patients will be treated with Manjisthadi Lepa and Crepe Bandage with the same type of diet to all the patients of both groups. |