| CTRI Number |
CTRI/2022/07/043895 [Registered on: 11/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic medicines in the management of cervical spondylosis |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic medicines selected using Repertory of Herings guiding symptoms of our materia medica by C.B.Knerr in the management of cervical spondylosis: An open label observational clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalsangzeli |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
National Institute Of HOmoeopathy, salt lake sector 3 block GE kolkata, West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9748150067 |
| Fax |
|
| Email |
sangzelihmar40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
National Institute Of HOmoeopathy salt lake sector 3 block GE kolkata West Bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9432497634 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
National Institute Of Homoeopathy, saltlake sector 3 Block GE kolkata west bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9432497634 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy,Block GE,sector3,salt lake,kolkata, West Bengal, 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
Block GE saltlake sector 3, kolkata 700106 |
| Type of Sponsor |
Government 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 |
| Lalsangzeli |
National Institute Of HOmoeopathy |
Department of Case Taking and Repertory,OPD NO-10 Block GE sector 3, Saltlake,West bengal 700106
North Twentyfour Parganas
WEST BENGAL |
9748150067
sangzelihmar40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine selected using Repertory of Herings Guiding symptoms of our Materia Medica by C.B.Knerr |
Intervention will be planned as administering indicated Homoeopathic medicine selected by proper repertorisation with Repertory of Herings Guiding Symptoms of our Materia Medica by C.B.Knerr. Each case will
be followed up at regular interval as per requirements.
Dose and frequency of dose depend on the patient. All patients shall be prescribed Homoeopathic medicine after detailed case taking in accordance with the direction laid down by Dr.Hahnemann in organon of medicine. Medicine selection, potency selection,repetition and follow up shall be done on the basis of fundamental guidelines.The follow up will be done monthly till 6 months from the baseline. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with clinical findings and or radiological findings for cervical spondylosis.
2. Both male and female patients of all religion and of different socioeconomic status.
3. Patients with known but controlled systemic diseases.
4.Patient willing to give consent for Homoeopathic treatment to take part in the study |
|
| ExclusionCriteria |
| Details |
1.Patienta suffering from any life threatening disease, fracture and previous surgery of neck.
2.Cases already undergoing Homoeopathic treatment elsewhere for any chronic diseases.
3.Cases of unstable mental or psychiatric illness.
4.Pregnant and lactating mothers
5.Self reported immune compromised state.
6.Substance abuse and/ or dependence.
7.Patient unwilling to sign the written informed consent form. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index |
base line and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
14/07/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical Spondylosis is degenerative disease of the cervical spine , intervertebral discs, ligaments and cartilaginous material. It is a common disease condition that considerably affects the quality of life of suffering individuals and the degenerative changes develop in the vertebral column with advancing age. Homoeopathy plays an important role in patients suffering from Cervical Spondylosis. So. an Open Label Observational Clinical Study will be conducted at National Institute Of Homoeopathy, Kolkata to know the effectiveness of Homoeopathic medicine in the management of Cervical Spondylosis. Study has a target to achieve a sample of 40 patients. Outcome assessment will be done based upon either increase or decrease in the pain using Neck Disability Index at baseline and after 6th month which will be compared and statistical analysis will be carried out to prepare statistical inference. |