| CTRI Number |
CTRI/2024/04/066526 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of individualized homoeopathic medicine in patients with chronic and acute type of pain.
|
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in pain management an open-label 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 |
Md Mirajul Haque |
| Designation |
UG Student (3rd B.H.M.S.) |
| Affiliation |
Metropolitan Homoeopathic Medical College And Hospital |
| Address |
OPD of department of gynecology and obstetrics of Metropolitan Homoeopathic Medical College and Hospital.
Ramchandrapur road ,sodepur kolkata 700110
OPD of department of gynecology and obstetrics of Metropolitan Homoeopathic Medical College and Hospital.
Ramchandrapur road ,sodepur kolkata 700110
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6294186241 |
| Fax |
|
| Email |
haquemirajul7467@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Md. Mirajul Haque |
| Designation |
UG Student (3rd B.H.M.S) |
| Affiliation |
Metropolitan Homoeopathic Medical College And Hospital |
| Address |
OPD of department of gynecology and obstetrics of Metropolitan Homoeopayhic Medical College and Hospital.
Ramchandrapur road,sodepur kolkata 700110
OPD of department of gynecology and obstetrics of Metropolitan Homoeopayhic Medical College and Hospital.
Ramchandrapur road,sodepur kolkata 700110
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6294186241 |
| Fax |
|
| Email |
haquemirajul7467@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Chandra Nath Das |
| Designation |
Principal |
| Affiliation |
Metropolitan Homoeopathic Medical College And Hospital |
| Address |
Principal room at Metyropoloitan Homoeopathic Medical College and Hospital.
Ramchandrapur road,sodedpur kolkata 700110
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
03325955326 |
| Fax |
|
| Email |
mhmch1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metropolitan Homoeopathic Medical College and Hospital.
Ramchandrapur,Sodepur,kolkata-700110 |
|
|
Primary Sponsor
|
| Name |
Metropolitan Homoeopathic Medical College And Hospital |
| Address |
Ramchandrapur Road,Sodepur, Kolkata-700110 |
| Type of Sponsor |
Private medical college |
|
|
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 Asit Bhowmick |
Metropliton Homoeopathic Medical College and Hospital |
Ramchandrapur Road sodeur kolkata700110,OPD& DEPARTMENT OF GYNECOLOGY AND OBSTETRICS DEPARTMENT
North Twentyfour Parganas
WEST BENGAL |
8240826264
asitbhowmick900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Individualized Homoeopathic medicine in the basis of totality of symptoms .We observe the efficacy of individualized homoeopathic medicine on 1week of intervention 3 times in a month.Dose is based on susceptibility of the patients and orally adminustered and total duration of intervention is 6 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from acute or chronic type of pain. 2.Patients willing to participate in the study and giving written consent of it. |
|
| ExclusionCriteria |
| Details |
1.Patients who are too unwell to take part 2.Self reported immune response person. 3.Substances abuse or /and independence. 4.individuals experiencing cyclic or intermittent pain such as those with condition like Mygraines,Dysmennorhoea,Cluster headaches,Endometriosis,Irritable bowel movementor other Episiodic pain disorders are excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mcgill pain questionnaire-It is used for evaluate a person expriencing significant pain.it is used monitor the pain over time and to determine the effectiveness of individualized Homoeopathic Medicine upto 1 months of 3 times intervention in every week. |
1Month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Euroqol 5d 5l-It is a visual analog scale.The descriptive system comprises of 5 dimension.This scale used for evaluate the severity of pain expriencing by some individual.It analyze the efficacy of Individualized Homoeopathic Medicine upto 1 month of intervention 3 times in every weak timeperiod. |
1Month |
|
|
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)
|
10/05/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [haquemirajul7467@gmail.com].
- For how long will this data be available start date provided 30-07-2024 and end date provided 30-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In single blind ,non- randomized, single arms trial ,30 patients will receive individualized homoeopathic medicine. Patient administered for severe pain both acute and chronic type. Severity index will taken as the primary and secondary outcomes respectively, measured at baseline. And observation taken at a 7 days interval up to 3 weeks of treatment |