| CTRI Number |
CTRI/2022/03/041106 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
06/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Validation of the treatment protocol for the management of bhagna with special reference knee sprain |
|
Scientific Title of Study
|
Validation of the treatment protocol for the management of bhagna with special reference to anterior cruciate ligament tear |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narinder Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9636015567 |
| Fax |
|
| Email |
narinder.1973@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narinder Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9636015567 |
| Fax |
|
| Email |
narinder.1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saroj Mani Pokhrel |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
6290952422 |
| Fax |
|
| Email |
ayur.sarojmani1@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan |
| 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 Saroj Mani Pokhrel |
National Institute of Ayurveda |
OPD no. 32, PG Department of Shalya Tantra Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
6290952422
ayur.sarojmani1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: Bhagna, (2) ICD-10 Condition:M236||Other spontaneous disruption of ligament(s) of knee. Ayurveda Condition: BAGNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandhi Taila, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with residual morbidity like pain, stiffness restricted ROM, wasting, swelling after injury to the ligamentous complex of knee joint.
2 All the subjects having injuries to the ligamentous complex of knee joint despite of its grading.
|
|
| ExclusionCriteria |
| Details |
• Acute Injuries of knee ligamentous complex.
1. Chronic knee sprains with comorbid illness requiring any other treatments.
2. Other conditions in which patient is unable to take proposed medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| KOOS Score |
2 weeks, 4 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, Tenderness, Swelling, Range of Motion |
2nd week, 4th week, 6th week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/04/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Injury to the knee during athletics is common and may limit future sports participation, but its long-term effects on patients are less well characterized. Knee ligament sprain is one of the most common orthopaedic and sports injuries. Acharya Sushruta has mentioned a very rational and established concept regarding the management of musculo-skeletal injuries under Bhagna which are very much evident from below mentioned references. These fundamentals from Ayurveda can be rationally incorporated in designing a treatment protocol for the validation of the effective recovery from sports injury. |