| CTRI Number |
CTRI/2024/09/073548 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment for Sprains |
|
Scientific Title of Study
|
Homoeopathic Intervention in Reducing The Pain of Ligament Sprains - A Clinical Interventional Study |
| 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 V P Varshiny |
| Designation |
PG Scholar |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Department Of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram PO
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9080862155 |
| Fax |
|
| Email |
varshinypalanisamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S R Binuraj |
| Designation |
Assistant Professor, Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Department Of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram PO
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9446106525 |
| Fax |
|
| Email |
drbinurajsr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S R Binuraj |
| Designation |
Assistant Professor, Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Department Of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram PO
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9446106525 |
| Fax |
|
| Email |
drbinurajsr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health |
|
|
Primary Sponsor
|
| Name |
Dr. V P Varshiny |
| Address |
Department Of Practice Of Medicine
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram PO,
Kurichy, Kottayam, Kerala - 686532 |
| 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 |
| Dr V P VARSHINY |
National Homoeopathy Institute in Mental Health |
Outpatient and In-patient departments, Peripheral centers and Camps conducted by the department of practice of medicine of NHRIMH, Kurichy, Sachivothamapuram PO
Kottayam
KERALA |
9080862155
varshinypalanisamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M242||Disorder of ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines |
Indicated Homoeopathic medicine with any potency starting from 6C to 50M (as per
the need of the case) will be administered. Patients will also be given physiotherapy
exercises according to their needs on a regular basis along with the prescribed
medicines. The potency, repetition and change of the remedy will be adjusted as per the
necessity of the follow-up. In case of any acute illness, the acute totality shall be taken
and medicine is prescribed and shall be documented accordingly |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 14 – 40 years of all genders.
2. Patients of mild to moderate ligament sprains.
|
|
| ExclusionCriteria |
| Details |
1. Patients presenting with any fractures or dislocations.
2. Patients with total or complete tear of ligament in MRI (or USG when MRI is
contraindicated) that requires immediate surgery.
3. Pregnant and lactating women.
4. Patients with known severe systemic illnesses such as uncontrolled diabetes, severe
cardiac diseases and malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in Total Pain Rating Index (T-PRI) of Short-form McGill Pain
Questionnaire (SF-MPQ). |
Every month from baseline till the conclusion of
the study (6th month)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in Activity, Sleep, Mood and Stress of DVPRS
supplemental questions of Defense and Veterans Pain Rating Scale 2.0
(DVPRS) |
Every month from baseline till the conclusion of
the study (6th month) |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2024 |
| 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 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
|
This study is a clinical interventional
study for the homoeopathic management of reducing pain of ligament sprains that
will be conducted in outpatient
and in-patient departments and peripheral centers and camps conducted by the
National Homoeopathic Research Institute in Mental Health, Kottayam. The primary
outcome measures will be to
evaluate the changes in Total Pain Rating Index (T-PRI) of Short-form mcGill Pain
Questionnaire (SF-MPQ). The secondary outcomes will be to evaluate the changes in
Activity, Sleep, Mood and Stress of DVPRS supplemental questions of Defense and
Veterans Pain Rating Scale 2.0 (DVPRS). As the study with the
aforementioned domains is one of its kind, it aims to make the efforts to offer
possibilities for future research in the effectiveness of Individualized
Homoeopathic Medicines in management of ligament sprains in general |