| CTRI Number |
CTRI/2024/09/074229 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy for management of lumbar spondylosis |
|
Scientific Title of Study
|
To Study Effect Of Individualized Homoeopathic Medicine In Pain And Disability Management Of Lumbar Spondylosis: A Single Blind Randomised Placebo Control Trial With Physiotherapy |
| 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 Hemangini Ashoksinh Chavda |
| Designation |
BHMS MD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
8849293126 |
| Fax |
|
| Email |
hemanginichavda1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigna Nimavat |
| Designation |
Associate Professor, Organon of Medicine |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7046705677 |
| Fax |
|
| Email |
jigna.nimavat87119@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemangini Ashoksinh Chavda |
| Designation |
BHMS MD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda,
Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
8849293126 |
| Fax |
|
| Email |
hemanginichavda1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Limda, Waghodia, Vadodara, Gujarat, 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Hemangini Ashoksinh Chavda |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Limda, Waghodia, Vadodara, Gujarat, 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 Hemangini Ashoksinh Chavda |
Jawaharlal Nehru Homoeopathic Hospital |
DEPT. Of Medicine,
room no.110,
Jawaharlal Nehru Homoeopathic Medical College,Parul university,Limda,Waghodia
Vadodara
GUJARAT |
8849293126
hemanginichavda1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine with Physiotherapy |
Individualized Homoeopathic Medicines are prescribed to individuals having symptoms of Lumbar Spondylosis on the basis of strict homoeopathic principles. Administration of the medicine will follow a sublingual route. A suitable potency which can be 30/200/1M according to susceptibility of the patient will be prescribed as per the homoeopathic principles. Repetition of the dose of homoeopathic medicine will be done as per the requirement of the case. The dose will be administered and evaluated on the basis of reduction or disappearance of the symptoms of lumbar spondylosis. |
| Comparator Agent |
Placebo with Physiotherapy |
placebo group patients will
receive identical
placebo which are globules moistened
with dispensing alcohol. Dose and repetition of the placebo will be in similar pattern to medicinal group.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 30-70 years.
2.New and Pre-diagnosed cases of Lumbar Spondylosis.
3.The patient giving their consent to participate in study.
4.Both the gender.
|
|
| ExclusionCriteria |
| Details |
1.Advanced and irreversible pathological cases which require immediate medical attention.
2.Pregnant and Lactating Women.
3.Patients who are taking any other medication for Lumbar Spondylosis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Homoeopathic medicine are effective in management of lumbar spondylosis.
2.Reduction in pain and disability of lumbar spondylosis. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the outcome of individualized homoeopathic medicine group and placebo group by analyzing the improvement in the cases of lumbar spondylosis with the help of oswestry disability index.
2.To assess the severity of pain and disability before and after in cases of lumbar spondylosis. |
5 month |
|
|
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)
|
01/10/2024 |
| 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="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
|
The study is single blind, Randomised, placebo control trial, which compare the outcome of individualized homoeopathic medicine group and placebo control group. In this study severity of pain and disability of lumbar spondylosis is evaluate by using Oswestry disability index. The physiotherapy is also included for both the groups as a part of management in cases of lumbar spondylosis. |