| CTRI Number |
CTRI/2024/03/064476 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the effects of Homoeopathic medicines on sciatica pain. |
|
Scientific Title of Study
|
A Clinical study to assess the effectiveness of organ specific Homoeopathic medicines in the pain management of sciatica |
| 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 Mohnyca Yumnam |
| Designation |
Doctor, PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth(Deemed to be University) Homoeopathic Medical College and Hospital Dept of Post Graduate and Research Centre, Pune-Banglore Highway,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8310443979 |
| Fax |
|
| Email |
mohnycy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mrinal Nerlekar |
| Designation |
MD HOM, HOD Practice of Medicine |
| Affiliation |
BVDU Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth(Deemed to be University) Homoeopathic Medical College and Hospital Dept of Post Graduate and Research Centre, Pune-Banglore Highway,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
Mrinal.nerlekar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mrinal Nerlekar |
| Designation |
MD HOM, HOD Practice of Medicine |
| Affiliation |
BVDU Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth(Deemed to be University) Homoeopathic Medical College and Hospital Dept of Post Graduate and Research Centre, Pune-Banglore Highway,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
Mrinal.nerlekar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College and Hospital,Dept of Post graduate and Research Centre. |
|
|
Primary Sponsor
|
| Name |
DrMohnyca Yumnam |
| Address |
Bharati Vidyapeeth(Deemed to be University) Homoeopathic Medical College and Hospital Dept of Post Graduate and Research Centre, Pune-Banglore Highway,Pune- 411043 |
| Type of Sponsor |
Other [] |
|
|
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 Mohnyca Yumnam |
BVDU Homoeopathic Medical College and Hospital, Dept of Post graduate and Research centre. |
Room no.19,Dept of Practice of Medicine, Bharati Vidyapeeth (Deemed to be University)Homoeopathic Medical College and Hospital,Dept. Of Post graduate and Research centre,pune.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8310443979
mohnycy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BHARATI VIDYAPEETH(DEEMED TO BE UNIVERSITY) PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic organ specific medicines. |
Homoeopathic organ specific medicines will be prescribed at the beginning of study and at every follow up(with duration of 7-14 days according to the requirements) and route of administration is oral.Total duration for each patient is 3 months in which enrollment day and 5 follow ups is included. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with diagnosed case of sciatica.
Patients who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
1)Excluding patients with red flags(such as cauda equina compression, cancer,spinal fracture,infections)
2)Peripheral neuropathy cases will be excluded.
3)Pregnant women will be excluded in this study.
4)Patients presenting with complications of sciatica will be EXCLUDED. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of the effectiveness of homoeopathic organ specific remedies in the pain management of sciatica in both sexes of the age group from 25 to 65 years. |
Wong-Baker Faces Pain Rating Scale will be used at day 1 and during every follow up at an interval of 7days/2 weeks according to the severity and requirements till 3 months(5 follow ups) to assess the effect of organ specific homoeopathic medicines in the pain management of sciatica. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of homoeopathic organ specific remedies in improving disability in sciatica. |
Wong-Baker Faces Pain Rating Scale and physical examination will be done at day 1 and during every follow up at an interval of 7days/2 weeks according to the severity and requirements till 3 months(5 follow ups) to assess the effect of organ specific homoeopathic medicines on stiffness in sciatica patients. |
|
|
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 |
Date of First Enrollment (India)
Modification(s)
|
15/04/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
A Clinical study to assess the effectiveness of organ specific Homoeopathic medicines in the pain management of sciatica. The duration of treatment will be of three months and will be done on 30 patients on BVDUHMC pune. The primary outcome will be assessed by using (Wong-Baker Faces Pain Rating Scale )score and follow up will be taken for three months to see the effectiveness of homoeopathic organ specific medicines in the pain management of sciatica of the age group 25-65 years. |