| CTRI Number |
CTRI/2024/05/067967 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the effectiveness of individualized homoeopathic medicine in cases of sciatica. |
|
Scientific Title of Study
|
A Prospective Interventional Study to Ascertain the Effectiveness of Individualized Homoeopathic Medicine in Cases 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. Jinalben R Malani |
| Designation |
Pg Scholar homoeopathic materia medica |
| Affiliation |
Rajkot Homoeopathic medical college parul university |
| Address |
Homoeopathic materia medica Rajkot homoeopathic medical college b/h jainath petrol pump gondal road Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
8000029908 |
| Fax |
|
| Email |
210409201005@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamna Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homoeopathic medical college parul university |
| Address |
Homoeopathic materia medica Department-Rajkot Homoeopathic Medical College b/h jainath petrol pump gondal road Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9029147800 |
| Fax |
|
| Email |
KAMNA.GUPTA17910@PARULUNIVERSITY.AC.IN |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Jinalben R Malani |
| Designation |
Pg Scholar homoeopathic materia medica |
| Affiliation |
Rajkot Homoeopathic medical college parul university |
| Address |
Homoeopathic Materia Medica department- Rajkot homoeopathic medical college b/h jainath petrol pump gondal road Rajkot
Rajkot
GUJARAT
Rajkot
India |
| Phone |
8000029908 |
| Fax |
|
| Email |
210409201005@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical college b/h jainath petrol pump gondal road Rajkot Gujrat India 290010 |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
Rajkot homoeopathic medical college b/h jainath petrol pump gondal road rajkot GUjrat India .390010 |
| 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 Jinalben R Malani |
sainath homoeopathic hospital Rajkot homoeopathic medical college parul university |
102 department of surgery Rajkot homoeopathic medical college b/h jainath petrol pump gondal road rajkot 390010
Rajkot
GUJARAT |
8000029908
210409201005@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH- RAJOKOT HOMOEOPATHIC MEDICAL COLLEGE PARUL UNIVERSITY GUJRAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Mode of Administration ORAL ROUTE, Potency 30,200,1M,10M F, repetation will be done Every Week Till Improvement is Seen |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients b/w 20 to 50 years of age, irrespective of sex , socio-economical status and occupation will be taken for study.
Clinically Diagnosed Cases of sciatica |
|
| ExclusionCriteria |
| Details |
1. GROSS PATHOLOGICAL CASES
2. CONGENITAL AND PURE SURGICAL CASES
3. PREGNANT AND BREAST- FEEDING WOMAN |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be some improvement after prescribing individualized homoeopathic medicine in cases of sciatica |
every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant improved - sensation of well being Physically & Mentally with disappearance of all the symptoms of sciatica for which patient approached , without recurrence within period pf study.
Marked improvement - Decreased in intensity and/or Frequency of presenting complaints with feeling of well being.
not improvement- no changes in presenting complaints. |
after every month 12 month end of the treatment |
|
|
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)
|
10/06/2024 |
| 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
|
Sciatica is defined as neuropathic pain affecting the back , hip , and outer side of leg caused by compression of a spinal nerve root in the lower back often owing to degeneration of an inter-vertebral disc. Depending on the nerve root involvement the degree of pain may extend to the foot or the toes usually affecting one side of the lower back. Cases of sciatica will be selected by keeping in view with inclusion and exclusion criteria. Homoeopathy as a natural system of medicine offers distinct advantages to the people who suffer from sciatica. The biggest advantage that homoeopathy offers is that it is able to treat the pain very effectively and able to rectify the compression or irritation on sciatic nerve. this study aims to assess the effectiveness of individualized homoeopathic medicine in cases of sciatica and to understand frequency and bothersome of sciatica. |