| CTRI Number |
CTRI/2025/11/097825 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Gnaphalium Polycephalum in patients with Sciatica aged 40-60 years |
|
Scientific Title of Study
|
Utility of Gnaphalium Polycephalum in adults aged 40-60 years with Sciatica: A prospective interventional study using Sciatica Bothersomeness Index (SBI) and Sciatica Frequency Index (SFI) |
| 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 Vivekbhai Meghjibhai Bhojani |
| Designation |
PG scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
OPD Room number 110
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Parul University
Waghodia
Vadodara
Gujarat
India
391760
Vadodara GUJARAT 391760 India |
| Phone |
7778062426 |
| Fax |
|
| Email |
vivekbhojani2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gaurav Sharma |
| Designation |
BHMS, MD Homoeopathy, HOD and Professor PG Department of Homoeopathic Materia Medica |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
PG Department of Homoeopathic Materia Medica
Jawharlal Nehru Homoeopathic Medical College and Hospital
Waghodia
Vadodara
Gujarat
India
391760
Vadodara GUJARAT 391760 India |
| Phone |
9824372731 |
| Fax |
|
| Email |
gaurav.sharma18479@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Vivekbhai Meghjibhai Bhojani |
| Designation |
PG scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
OPD Room number 110
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Parul University
Waghodia
Vadodara
Gujarat
India
391760
Vadodara GUJARAT 391760 India |
| Phone |
7778062426 |
| Fax |
|
| Email |
vivekbhojani2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University
Waghodia
Vadodara
Gujarat
India
391760 |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Parul University
Waghodia
Vadodara
Gujarat
India
391760 |
| 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 Vivekbhai Meghjibhai Bhojani |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
OPD Room number 110
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Parul University
Waghodia
Vadodara
Gujarat
India
391760 Vadodara GUJARAT |
7778062426
vivekbhojani2001@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: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gnaphalium Polycephalum |
Gnaphalium Polycephalum Homoeopathic Medicine with potency as per patient susceptibility and repetition every 15 days will be given. |
| Comparator Agent |
NOT APPLICABLE |
This is a single arm study, so comparator agent is not taken |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with positive Straight Leg Raising Test (SLRT).
2. Patients from both the sexes between the age of 40yrs-60yrs having pain will be included.
3. Patients willing to give consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with other systemic illness or congenital deformities.
2. Cases of pregnant woman or lactating woman
3. Patient taking any other mode of treatment.
4. Cases with irregular follow up will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marked Improvement
Moderate Improvement
Mild Improvement
Status Quo
Any increase in Sciatica Bothersomeness Index and Sciatica Frequency Index score from the baseline score will be counted as worse. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/01/2026 |
| 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
|
Although some studies underscore the therapeutic potential of homeopathy in managing sciatica, notable gaps remain in methodological diversity and long-term outcome evaluations. Dr. Garg’s study specifically highlights the effectiveness of Gnaphalium polycephalum, especially in cases involving numbness, yet it lacks comparative assessments with other frequently used remedies. On the other hand, Dr. Marathe’s observational study presents promising results with individualized constitutional approaches but does not explore remedy-specific interrelations or subgroup responsiveness, such as age related variations or chronicity. Additionally, neither study investigates patient quality of life, relapse rates, or cost-effectiveness over extended periods. There is a need for well-structured follow-up studies exploring broader clinical parameters and integrating qualitative feedback from patients to enhance the depth and reliability of outcomes. This prospective, interventional, single arm clinical study aims to evaluate the therapeutic role of Gnaphalium Polycephalum in management of pain intensity and frequency due to Sciatica. Fifty eligible participants will be recruited from Jawaharlal Nehru Homoeopathic Medical College and Hospital, Vadodara, Gujarat, over a study period of one year. The pain intensity, pain frequency and treatment outcomes will be assessed using the Sciatica Bothersomeness Index and Sciatica Frequency Index. |