| CTRI Number |
CTRI/2022/03/040801 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
03/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the role of Homoeopathic Medicines in the treatment of Cervical spondylosis |
|
Scientific Title of Study
|
To Study the Usefulness of Homoeopathic Treatment in Cervical Spondylosis: A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manleen Kaur |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Departemnt of Practice of Medicine
Room No. B 16 & B 17
Basement Floor
36 B
Knowledge Park I
Greater Noida
Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9873739378 |
| Fax |
|
| Email |
manleenkr9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD, Materia Medica & PG Incharge |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Post Graguate Incharge
Room No G 21
Grund Floor
36 B
Knowledge Park I
Greater Noida
Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
ashraj1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Chowdhury |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic medical College & Hospital |
| Address |
Department of Practice of Medicine.
Room No. B 16 & B 17
Basement Floor
36 B
Knowledge Park I
Greater Noida
Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8826797839 |
| Fax |
|
| Email |
dr.rashmichowdhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical Hospital |
| Address |
36 B
Knowledge Park I
Greater Noida
Gautam Buddh Nagar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
NOT Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manleen Kaur |
Bakson Homoeopathic Medical College & Hospital |
Outpatient Department (OPD)
Inpatient Departemnt (IPD)
Ground Floor
36 B
Knowledge Park 1
Greater Noida
Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9873739378
manleenkr9@gmail.com |
| Manleen Kaur |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Outpatient Department (OPD)
Room No. 110
Ground Floor
A 1/1 Sector 24 Noida Gautam Buddha Nagar UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9873739378
manleenkr9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homoeopathic Medical College & Hospital |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
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 |
Homoeopathic Medicine |
Homoeopathic Medicine based on case taking.
Follow ups every 15 days for 6 months.
Dosage will be according to the requirement of the case in centismal potency.
Repetition of medicine will be according to the severity of the case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 35 – 54 years doing desk job.
2. Diagnosed cases.
|
|
| ExclusionCriteria |
| Details |
1. Patients with age below 35 years and above 55 years.
2. Patients with nonspecific neck pain like acute neck strain, postural neck ache, any injury, psychogenic neck pain.
3. Pregnant and lactating females.
4. Inflammatory disease like rheumatoid arthritis, ankylosing spondylitis.
5. Patients suffering from systemic disorders and comorbidities.
6. Patients on any other mode of treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that there will be a reduction in the Neck disability index in patients with cervical spondylosis after homoeopathic treatment. |
NDI will be assessed every 4 weeks for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that the quality of life of patients will be improved. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
10/03/2022 |
| 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="0"
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
|
Role of Homoeopathy in Cervical Spondylosis. 33 cases will be included in the study. Scale used will be Neck Disability Index. it is expected that there will be reduction in Neck Disability Index after giving Homoeopathic treatment and further progression of the disease will stop. it is also expected that the quality of life will improve after the homoeopathic treatment.
|