| CTRI Number |
CTRI/2025/09/095319 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To See the Effect of Homoeopathic Medicine name Agaricus Muscarius in Cases of Sciatica |
|
Scientific Title of Study
|
The Effectiveness of Agaricus Muscarius in Management of Sciatica : A Clinical Verification Study |
| 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 Sonal Panchmatiya |
| Designation |
Professor, Department of Homoeopathic Materia Medica |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Panchmatiya |
| Designation |
Professor, Department of Homoeopathic Materia Medica |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krusha Gandhi |
| Designation |
PG Scholar |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
F/8 Tejas apartment 2 Rayanwadi society Bamroli road
Godhra
Panchmahal
Gujarat
Panch Mahals
GUJARAT
389001
India |
| Phone |
6354653441 |
| Fax |
|
| Email |
krushagandhi18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road
Anand 388001
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
Dr Krusha Gandhi |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital, Hahnemann House, Amul Dairy Road, Anand 388001, Gujarat
India |
| 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 |
| DrKrusha Gandhi |
Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001 |
Room Number 4 Department of Medicine Dr V H Dave Homoeopathic Medical College Hahnemann House Amul Dairy Road
Anand-388001
Anand
GUJARAT |
6354653441
krushagandhi18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECVHDHMC |
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 |
Agaricus muscarius |
Dose 6c/30c/200c/1M
Repetition OD/BDS/TDS
Route of administration of medicine: oral
The Dose and repetition of Agaricus muscarius will be selected depending upon the susceptibility of the patients.
Case wiil be reviewed every 7/10/15 days depending upon the requirement of the case.
The duration of study will 9 month. |
| Comparator Agent |
No Comparator |
No Comparator |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age group 20-70 years will be screened irrespective of gender.
Clinically confirmed cases of Sciatica where Agaricus muscarius is indicated will be included.
Only those participants who willingly give informed consent will be enrolled in the study
|
|
| ExclusionCriteria |
| Details |
Individual with severe neurological deficits such as foot drop, or significant motor weakness will be excluded.
Pregnant or Breastfeeding female
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sciatica Bothersomeness Index (SBI) |
Follow up at every 2 weeks and At the End of treatment as per the requirements of the case |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="9"
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 title The Effectiveness of Agaricus muscarius in Management of Sciatica A Clinical Verification Study is designed to scientifically evaluate the therapeutic role of Agaricus muscarius in clinically confirmed cases of sciatica Sciatica characterized by radiating pain along the sciatic nerve due to lumbar disc herniation spinal stenosis or degenerative changes is commonly managed with conventional therapies that often provide only symptomatic relief and may have adverse effects Homeopathy with its holistic and individualized approach presents an alternative and Agaricus muscarius with its recognized action on the nervous system is frequently prescribed in neuralgic conditions resembling sciatica but lacks formal verification This analytical interventional uncontrolled clinical trial will be conducted over nine months at Smt. S. I. Patel (I) Homoeopathic Hospital Anand with purposive sampling of 37 patients aged 20–70 years from a study population of 77 Clinical assessment will be performed using the Sciatica Bothersomeness Index (SBI) with baseline and follow-up evaluations every 7–15 days for six months Prescription of Agaricus muscarius will be based on symptom similarity with potency selected according to susceptibility Data analysis will employ percentage change in SBI scores and statistical testing using paired t-test in Microsoft Excel Ethical clearance has been obtained The study aims to generate clinical evidence on the effectiveness of Agaricus muscarius in sciatica management thereby contributing to evidence-based homoeopathic practice |