FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/06/043143 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On: 03/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathy in treatment of Lumbar Spondylosis 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicines in the treatment of pain and stiffness in middle aged Lumbar Spondylosis patients: A single group, pre- post interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nabanita Kundu 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Homoeopathic Materia Medica. Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Dr B.N Chakraborty sarani. Dumurjola, Howrah-711104

Haora
WEST BENGAL
711104
India 
Phone  7908659741  
Fax    
Email  kundunabanitanih25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Baishakhi Ghosh 
Designation  Lecturer 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical college and Hospital 
Address  Department of Homoeopathic Materia Medica. Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Dr B.N Chakraborty sarani. Dumurjola, Howrah-711104

Haora
WEST BENGAL
711104
India 
Phone  8442992146  
Fax    
Email  drbaishakhibhatt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Baishakhi Ghosh 
Designation  Lecturer 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical college and Hospital 
Address  Department of Homoeopathic Materia Medica. Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Dr B.N Chakraborty sarani. Dumurjola, Howrah-711104

Haora
WEST BENGAL
711104
India 
Phone  8442992146  
Fax    
Email  drbaishakhibhatt@gmail.com  
 
Source of Monetary or Material Support  
Dr.Nabanita Kundu 
 
Primary Sponsor  
Name  Dr Nabanita Kundu 
Address  Department of Homoeopathic Materia Medica. Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Dr.B.N Chakraborty Sarani. Dumurjola, Howrah-711104 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrNabanita Kundu  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Department of Homoeopathic Materia Medica. Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Dr.B.N Chakraborty Sarani. Dumurjola, Howrah-711104
Haora
WEST BENGAL 		 7908659741

kundunabanitanih25@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Homoeopathic Medicine will be selected based on the presenting complaints and the totality of symptoms. The medicine will be prescribed in centesimal potencies. medicines will be prescribed once daily for two days in morning empty stomach. Repeatation of medicine will be done as per prognosis of the cae. All the medicines have been thoroughly proved and the details are written in Materia Medica Pura.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Age group is 45-60 years
-Both sexes
-Patient with chief complaint of pain and stiffness in low back region.
-Patient is willing to give consent.
-Patient is willing and able to follow all study instructions and to attend all study visit 
 
ExclusionCriteria 
Details  -Severe degeneration of lumbar and sacral spine.
-Diagnosed case of unstable psychiatric illness.
-Diagnosed case of uncontrolled life-threatening illness affecting quality of life.
-Patient of pregnancy and lactation
-Patient of malignancy
-Immunocompromised patient
-Inability to comply with the study protocol, alcoholic, drug users 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analog scale (VAS) for pain and stiffness is a scale of 0 to 100 mm (“0” score indicate no
symptoms, whereas 100 mm indicates worst possible symptoms, before and after treatment 		 Outcome will be assessed initially at the baseline 4 weeks interval up to 6 months.  
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index Questionnaire. The scores of all questions answered are summed, then
multiplied by two to obtain the index (range 0-100). Where 0%-20%: minimal disability, 21%-40%:
moderate disability, 41%-60%: severe disability, 61%-80%: crippling back pain,81%-100%: these patients
are either bed-bound or have an exaggeration of their symptoms. 		 Outcome will be assessed initially at the baseline 4 weeks interval up to 6 months. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   19/06/2022 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kundunabanitanih25@gmail.com].

  6. For how long will this data be available start date provided 12-12-2023 and end date provided 13-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Lumbar Spondylosis is a degenerative process affecting the vertebral disc and facet joint of lumbar and sacral spine which at time causes nerve root compression, lumbar radicular pain, as well as musculoskeletal back pain, and stiffness in the low back region along with muscle spasm and tightness. The 2010 Global Burden of Disease Study estimated that low back pain is amongst the top 10 diseases that account for the highest no of disability adjusted life years worldwide. [6] Lumbar Spondylosis is responsibl for 10% of all low back pain. [2] Now a days it is very common in elder people but it has been found to be  as high in athletes that is in middle age group. It is very frequently seen in middle aged to elderly population due to postural defect, in which the curves are emphasized and this result in the joint, muscle and vertebrae being in stressful position [7] In modern medicine, palliation through NSAID and EPIDURAL STEROID INJECTION can be done but this medication have side effects such as ulcer, bleeding, perforation etc. [2] Other physical therapy management can be beneficial but that only is not enough to manage lumbar spondylosis. There is no such study in the treatment of pain and stiffness in middle aged lumbar spondylosis patient and also as we know it is a degenerative condition of vertebral disc and facet joints of bones. Hence, I have decided to choose the topic lumbar spondylosis in middle age group of people if we can halt the degenerative process before hand with our individualized Homoeopathic medicine and also to see the effectiveness in treating the pain and stiffness in middle aged lumbar spondylosis patient.
Research Question -Do Individual Homoeopathic Medicines have role in the treatment of pain and stiffness in middle aged
lumbar spondylosis patient?

Hypothesis

Null Hypothesis (H0) There will be no significant changes in VAS scale and Oswestry Disability Index score in the treatment of pain and stiffness in middle aged lumbar spondylosis patient.
Alternative Hypothesis (HA) There will be significant changes in VAS scale and Oswestry Disability Index score in the treatment of pain and stiffness in middle aged lumbar spondylosis patient.
 
Close