| CTRI Number |
CTRI/2024/05/066767 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic management in cases of sciatica along with Physiotherapy |
|
Scientific Title of Study
|
A Comparative prospective study to ascertain the role of
Gnaphalium Polycephalum alongwith Physiotherapy in
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. Gaurav Bhatt |
| Designation |
Principal |
| Affiliation |
Ahmedabad Homoeopathic Medical college, Parul university |
| Address |
Room No.4, 1st Floor, Department of Practice of
Medicine, Ahmedabad Homoeopathic Medical Collage, opp. Kabir Enclave
Bopal-Ghuma Road, Ghuma
Room No.4, 1st Floor, Department of Practice of
Medicine, Ahmedabad Homoeopathic Medical Collage, opp. Kabir Enclave
Bopal-Ghuma Road, Ghuma
Ahmadabad
GUJARAT
380058
India |
| Phone |
8153003828 |
| Fax |
|
| Email |
gaurav9bhatt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kirtida Desai |
| Designation |
Professor |
| Affiliation |
Jawaharla Nehru Homoeopathic Medical, Parul university |
| Address |
Room No. 101, Department of Practice of Medicine, Jawaharlal Nehru Homoeopathic Medical Collage, Parul university, At. Post. Limada, Waghodiya
Room No. 101, Department of Practice of Medicine, Jawaharlal Nehru Homoeopathic Medical Collage, Parul university, At. Post. Limada, Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
9898299611 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Gaurav Bhatt |
| Designation |
Principal |
| Affiliation |
Ahmedabad Homoeopathic Medical college, Parul university |
| Address |
Room No.4, 1st Floor, Department of Practice of
Medicine, Ahmedabad Homoeopathic Medical Collage, opp. Kabir Enclave
Bopal-Ghuma Road, Ghuma
Room No.4, 1st Floor, Department of Practice of
Medicine, Ahmedabad Homoeopathic Medical Collage, opp. Kabir Enclave
Bopal-Ghuma Road, Ghuma
Ahmadabad
GUJARAT
380058
India |
| Phone |
8153003828 |
| Fax |
|
| Email |
gaurav9bhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| AHMEDABAD HOMOEOPATHIC MEDICAL COLLAGE, OPP. KABIR ENCLAVE,
BOPAL-GHUMA ROAD, GHUMA, AHMEDABAD - 380058 |
|
|
Primary Sponsor
|
| Name |
AHMEDABAD HOMOEOPATHIC MEDICAL COLLAGE |
| Address |
OPP. KABIR ENCLAVE, BOPAL-GHUMA
ROAD, GHUMA, AHMEDABAD - 380058 |
| 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 GAURAV BHATT |
SAINATH HOSPITAL AFFILATED WITH AHMEDABAD HOMOEOPATHIC MEDICAL COLLAGE |
ROOM NO.1, MEDICINE OPD,
BOPAL-GHUMA ROAD,GHUMA
Ahmadabad
GUJARAT |
8153003828
gaurav9bhatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR-SAINATH HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G570||Lesion of sciatic nerve, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC MEDICINE -GNAPHALIUM POLYCEPHALUM |
ACCORDING TO
SUCEPTIBILITY OF PATIENT
FOR EXAMPLE 30,
200,1M
ROUTE OF
ADMINISTRATION: ORAL
DURATION OF TRIAL - 12 MONTHS |
| Comparator Agent |
PHYSIOTHERAPY |
MODERATE APPLICABLE EXCERCISE AND DIATHERMY |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
-Patients presenting with clinical features of sciatica or pre-diagnosed cases of sciatica
-Patients suffering from sciatica, willing to participate and taking treatment regularly and co-operating for regular follow-up and giving consent for the study will be included.
-Patients presenting with totality of Gnaphalium
|
|
| ExclusionCriteria |
| Details |
-Patients reporting with neurological or surgical complications.
-Patients not coming for consecutive 3 follow-ups
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To establish scope of homoeopathic medicine Gnaphalium Polycephalum in management of sciatica
2. Homoeopathic management along physiotherapy beneficial for sciatica patient |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Homoeopathic management along physiotherapy beneficial for sciatica patient |
8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/05/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Homoeopathic
management of sciatica along with the auxilary treatment show remarkable resulting most
of the cases after prescribing indicated remedy patient started improving mentally and physically as the indicated remedy corrected the patients
constitution.
Proper
auxilary
treatment, were found effective in bringing significant improvement in the patient. Gnaphalium
will help in reducing sciatica and help in improving the quality of life of
patient. A study will help in evaluating the
role or effectiveness of Gnaphalium in relation with physiotherapy in cases of
Sciatica. it is the best remedy in the absence of the other symptoms and many
others consider it specific.
In sciatica, physiotherapy treatment is also
beneficial, as physiotherapy may provide symptom relief, promote healing of the
underlying cause, Prevent recurrences and flareups. |