| CTRI Number |
CTRI/2025/10/095536 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Homomeopathy Helps in Sciatica a study based on Patient own words |
|
Scientific Title of Study
|
Study of scope & management of Sciatica using Homeopathic medicines selected using Complete repertory and preparation of a repertory and therapeutics for the same and an attempt to create a list of verbatim by the patient describing the complaints |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hinalben Manharbhai Prajapati |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Block No 135 Prashil park society Near A G Quarter University Road Rajkot
Room no 102 Surgery OPD Gondal road Near makkam chowk Udhyog Nagar colony Bhaktinagar Rajkot 360002
Rajkot
GUJARAT
360005
India |
| Phone |
9106593509 |
| Fax |
|
| Email |
aestheticph071@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashyap Premsawala |
| Designation |
Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
D 83 Karmachari co op housing society section 1 Ghatlodiya Road Rannapark Ahemdabad
Room no 102 Surgery OPD Gondal road Near makkam chowk Udhyog Nagar colony Bhaktinagar Rajkot 360002
Rajkot
GUJARAT
380061
India |
| Phone |
9727173799 |
| Fax |
|
| Email |
k2krp@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Hinalben Manharbhai Prajapati |
| Designation |
Md scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Block No 135 Prashil Park Society Near A G Quwaters University Road Rajkot
Room no 102 Surgery OPD Sainath Hospital Gondal Road Near makkam chowk Udhyog Nagar colony Bhaktinagar Rajkot 360002
Rajkot
GUJARAT
360005
India |
| Phone |
9106593509 |
| Fax |
|
| Email |
aestheticph071@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College Gondal Road Near makkam chowk Udhyog Nagar colony Bhaktinagar Rajkot 360002
Rajkot |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
Room No 102 Surgery OPD Gondal Road Near makkam chowk Udhyog Nagar colony Bhaktinagar rajkot |
| 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 |
| Hinalben Manharbhai Prajapati |
Sainath Homoeopathic Hospital |
Room No 102 Surgery OPD Gondal Road makkam chowk Udhyog Nagar colony Bhaktinagar Rajkot
Rajkot
GUJARAT |
9106593509
aestheticph071@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Human Research Rajkot Homoeopathic medical college RHMC Parul University GUJARAT |
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 |
| Comparator Agent |
Not applicable |
Single arm prospective interventional study. |
| Intervention |
STUDY OF SCOPE AND MANAGEMENT OF SCIATICA USING HOMEOPATHIC MEDICINES SELECTED USING COMPLETE REPERTORY AND PREPARATION OF A REPERTORY AND THERAPEUTICS FOR THE SAME AND AN ATTEMPT TO CREATE A LIST OF VERBATIM BY THE PATIENT DESCRIBING THE COMPLAINTS |
Individualized Homeopathic medicines will be prescribed to patients with Sciatica based on case-taking repertorial totality using the Complete Repertory and clinical judgment. Remedies such as Colocynthis Rhus toxicodendron Bryonia alba Magnesia phosphorica Gnaphalium polycephalum Arsenicum album Lycopodium Sulphur etc. may be used selected as per symptom similarity and individual susceptibility.
Medicines will be administered orally in centesimal e.g. 30C, 200C or LM potencies according to case requirements. Treatment duration will be 3 months with a minimum of 3 follow-up visits. No fixed drug or dosage is predetermined. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clincally diagnosed sciatica with radiating pain and positive Straight Leg Raising test. Written informed consent obtained. VAS pain score 4 or above. |
|
| ExclusionCriteria |
| Details |
Acute neurological deficit or need for urgent surgery. Secondary sciatica due to tumor,infection, diabetes neuropathy, osteoarthritis, rheumatoid arthritis.Patients on other treatment for sciatica. Pregnant or lactating women. Psychiatric illness or cognitive impairment. Past spinal surgery or major trauma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Pain Intensity assessed using the Visual Analog sclae for Sciatica. Where 0 means no pain and 10 means worst pain. |
Baseline 15 days, 30 days, 45 days post treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of Homoeopathy remedies selection & rubrics used from complete repertory & analysis of patient expressions verbatim. |
Base line 6 week |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/10/2025 |
| 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="0"
Months="11"
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
|
This study evaluates the effectiveness of individualized homeopathic medicines selected using the Complete Repertory for managing sciatica. Pain intensity is assessed using the Visual Analog Scale (VAS) at multiple time points. The study also tries to develop a sciatica-specific repertory and create a glossary of patient verbatim symptom descriptions. Conducted as a prospective interventional trial with 40 patients over 9 months, the research combines VAS pain assessment and qualitative symptom analysis to improve homeopathic treatment for sciatica. |