| CTRI Number |
CTRI/2024/06/069410 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to relieve the symptoms of low back pain using Hughesian method |
|
Scientific Title of Study
|
A Prospective study on the Homoeopathic Management of patients with low back pain using Hughesian Method |
| 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 FATHIMA NASREEN K |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room No.403,IIIrd Flood, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College,Kulasekharam, Kanniyakumari District.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8825650527 |
| Fax |
|
| Email |
fathimanasreen1404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M MURUGAN |
| Designation |
Professor and HOD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room No.403,IIIrd Flood, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari District.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M MURUGAN |
| Designation |
Professor and HOD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room No.403,IIIrd Flood, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College,Kulasekharam, Kanniyakumari District.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTION - Sarada Krishna Homoeopathic Medical
College,Kulasekharam, Kanniyakumari District, Tamil Nadu 629161, India. |
|
|
Primary Sponsor
|
| Name |
Post Graduate Research Funded by College |
| Address |
Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, TAMILNADU 629161 |
| 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 FATHIMA NASREEN K |
Sarada Krishna Homoeopathic Medical College. |
Room No.403,IIIrd Flood, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College,Kulasekharam.
Kanniyakumari
TAMIL NADU |
8825650527
fathimanasreen1404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Construction of Totality of symptoms according to Richard Hughes method |
Cases with Low back pain fulfilling the Inclusion criteria will be purposively selected and recorded in the pre-structured case format.
The cases are then analyzed and a totality is erected according to Richard Hughes method.
Repertorisation is done if necessary. Thus a suitable Homoeopathic similimum and potency is selected accordingly.
Follow up will be done in a period of 2 weeks for 6 months.
Repetition of dose is based on Homoeopathic principles.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18 years – 85 years.
Both sexes.
Patient having symptomatology of Low back pain. |
|
| ExclusionCriteria |
| Details |
Patient below 18 years and more than 85 years.
Pregnant and Lactating women.
Patients with other co-morbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of the Homoeopathic similimum prescribed using Hughesian method. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic and general improvement in patient’s condition is evaluated using Roland – Morris Disability Questionnaire (RMDQ) as an assessment tool. |
6 MONTHS |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In 2020, Low back pain affected 619 million people and it is estimated that the number of cases will increase to 843 million cases by 2050, which is driven largely by the population expansion and ageing. It is the major cause of activity limitation and reduced quality of life resulting in a significant medical burden and economic expense. It can significantly affect quality of life. Homoeopathy is most effective in treating Low back pain with Simple, gentle and cost effective . For treating a case most effectively using homoeopathy it is very important to consider the patient as a whole, by prescribing Homoeopathic Similimum on the basis of Hughesian method. The case was analyzed and totality erected using Hughesian method and suitable similimum will be prescribed, selection of potency and repetition of dose is based on Homoeopathic method. Changes observed in the patient was recorded on subsequent follow-ups, Pre and Post assessment is done using the Roland – Morris Disability Questionnaire (RMDQ) to evaluate the improvement of the patient during visits. |