| CTRI Number |
CTRI/2025/06/089793 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO STUDY THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN CASE OF ANKLE SPRAIN WITH AUXILLARY MEASURES |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY OF INDIVIDUALIZED
HOMOEOPATHIC MEDICINE IN CASE OF ANKLE SPRAIN
WITH AUXILLARY MEASURES: A SINGLE BLIND
RANDOMIZED PLACEBO CONTROLLED TRIAL |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANJAYGUPTA |
| Designation |
PG SCHOLAR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 401, PG DEPARTMENT OF ORGANON OF MEDICINE
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
8839100898 |
| Fax |
|
| Email |
sanjay12rkdf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JIGNA NIMAVAT |
| Designation |
BHMS MD (HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 402 B, DEPARTMENT OF ORGANON OF MEDICINE
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
7046705677 |
| Fax |
|
| Email |
jigna.nimavat87119@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR JIGNA NIMAVAT |
| Designation |
BHMS MD (HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICA; COLLEGE |
| Address |
ROOM NO 402 B DEPARTMENT OF ORGANON OF MEDICINE
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, WAGHODIA, VADODARA
GUJARAT
391760
India |
| Phone |
7046705677 |
| Fax |
|
| Email |
jigna.nimavat87119@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, LIMDA, WAGHODIA, VADODARA, 391760 |
|
|
Primary Sponsor
|
| Name |
SANJAY GUPTA |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, PARUL UNIVERSITY, WAGHODIA VADODARA, 391760 |
| 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 SANJAY GUPTA |
JAWAHARLAL NEHRU HOMOEOPATHIC HOSPITAL |
OPD NO 110 DEPARTMENT OF ORGANON OF MEDICINE
Vadodara
GUJARAT |
8839100898
sanjay12rkdf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE (INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AUXILLARY MEASURES |
RICE PROTOCAL WITH INDIVIDUALIZED HOMOEOPATHIC MEDICINE EVERY 15 DAYS WITH MINIMUM 3 FOLLOW UPS |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE AND PLACEBO |
AS THIS STUDY SINGLE BLIND RANDOMIZED PLACEBO CONTROLLED TRIAL EVERY 15 DAYS WITH MINIMUM 3 FOLLOW UPS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Gender – Both Male and Female.
2.All patients between 18 to 40 years of age.
3.Cases prediagnosed with grade 1 and 2 of ankle sprain.
4.All Socio-economic status.
5.Patients willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or breastfeeding women.
2.Cases with grade III ankle sprain.
3.Cases with chronic ankle instability and Severe arthritis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO STUDY THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN THE TREATMENT OF ANKLE SPRAIN WITH AUXILLARY MEASURES.
TO DETERMINE THE DIFFERENCE IN RECOVERY TIME, PAIN MANAGEMENT AND FUNCTIONAL OUTCOMES BETWEEN THE TWO TREATMENT MODALITIES |
3 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NUMERIC PAIN RATING SCALE
0-10 |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
08/07/2025 |
| 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="0"
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
Modification(s)
|
The study is to see the efficacy of individualized homoeopathic medicine in the case of ankle sprain with auxillary measures, a single blind randomized placebo controlled trial. The study will be conducted in 40 participants in each group which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College and Hospital, Vadodara, Gujarat, India. numeric pain rating scale will be used for assessment purpose. The study will be conducted in the time duration of 1 year. |