| CTRI Number |
CTRI/2025/08/092855 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Homoeopathic remedies for Men with Lumbar Spondylosis :Results from a clinical Trial |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic remedy selection using Synthesis Repertory 9.1 in male patients with Lumbar Spondylosis: A randomized 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 |
Dr Madhumitha K |
| Designation |
Post Graduate |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 301
2nd floor
Department of Homoeopathic Repertory and Case Taking
Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8825417509 |
| Fax |
|
| Email |
mithra100100k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman sankar A S |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 301
2nd floor
Department of Homoeopathic Repertory and Case Taking
Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman sankar A S |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 301
2nd floor
Department of Homoeopathic Repertory and Case Taking
Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
post graduate dissertation Sarada Krishna Homoeopathic Medical college and hospital |
| Address |
room no 107
ground floor
Sarada Krishna homoeopathic medical college and hospital
Kulasekharam
Kanyakumari 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 Madhumitha K |
Sarada Krishna Homoeopathic Medical College and Hospital |
Room no 107 ground floor
Hospital building
Sarada Krishna Homoeopathic Medical College and Hospital
kulasekharam
kanyakumari district 629161
Kanniyakumari
TAMIL NADU |
8825417509
mithra100100k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College and Hospital |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
homoeopathic medicine calcarea fluorica 6x |
Calcarea Fluorica 6x will be prescribed daily 2 tabs twice daily for 2 to 3 months and treat outcomes will be compared with group 1
|
| Intervention |
Individualized homoeopathic Medicines |
individualized homoeopathic medicines selected through repertorisation from syntheis repertory 9.1 and administered daily orally 30th potency 2 globules after food at morning once |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed with Lumbar Spondylosis based on clinical examination and X ray findings |
|
| ExclusionCriteria |
| Details |
Female patients are excluded
Severe disability will not be included in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of individualized homoeopathic remedies in managing Lumbar Spondylosis in males as assessed by changes in clinical symptoms
Reduction in pain intensity and improvement in mobility measured using validated tools such
as the Oswestry Low Back Pain Disability Index (ODI), visual analog scale (VAS)
Improvement in quality of life evaluated through patient reported outcome measures |
fort nightly reduction in pain intensity assessed once in 15 days
end of 2 months changes in pain improvement in mobility quality of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identification of frequently used rubrics in the treatment of Lumbar Spondylosis as per Synthesis Repertory 9.1
Analysis of the most commonly selected remedies based on repertorization results for Lumbar Spondylosis cases |
2 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="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
|
Lumbar spondylosis is a common degenerative condition leading to chronic lower back pain and reduced mobility particularly in males Conventional treatments offer limited long term relief and may cause side effects Homoeopathy emphasizing individualized treatment offers a potentially effective alternative This study investigates the efficacy of homoeopathic prescriptions based on Synthesis Repertory 9.1 in comparison to standard treatment with Calcarea Fluorica 6X The objective is to evaluate the clinical effectiveness of individualized homoeopathic treatment selected through repertorization using Synthesis Repertory 9.1 in managing lumbar spondylosis and to compare outcomes with a control group receiving Calcarea Fluorica 6X The methodology is a randomized controlled trial was conducted on 20 male patients in each group diagnosed with lumbar spondylosis Participants were randomly allocated into two groups one received individualized homoeopathic remedies based on Synthesis Repertory 9.1 the control group received Calcarea Fluorica 6X Clinical outcomes were assessed using the Oswestry Low Back Pain Disability Index (ODI) and visual analog scale (VAS) over a 12 week period The study aims to determine changes in pain intensity disability and quality of life as well as identify the most frequently used rubrics and remedies for lumbar spondylosis Statistical analysis will include Chi square test and paired t test for between and within group comparisons respectively This research intends to fill the gap in evidence regarding the effectiveness of repertory-based individualized homoeopathic treatment in lumbar spondylosis |