| CTRI Number |
CTRI/2023/04/051570 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in improving quality of life in patients with cervical spondylosis |
|
Scientific Title of Study
|
USEFULLNESS OF INDIVIDUALIZED HOMOEOPATHIC TREATMENT IN IMPROVING QUALITY OF LIFE IN PATIENTS
WITH CERVICAL SPONDYLOSIS: AN OBSERVATIONAL, PROSPECTIVE, SINGLE-ARM, 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 |
Dr Akhilesh Singh |
| Designation |
Junior Resident |
| Affiliation |
Nehru homoeopathic medical College and hospital |
| Address |
Department of practice of medicine,Nehru homoeopathic medical College and hospital B Block Defence Colony New Delhi -110024
South
DELHI
110024
India |
| Phone |
9013078361 |
| Fax |
|
| Email |
akhilesh27061997@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Thakkar |
| Designation |
Professor |
| Affiliation |
Nehru homoeopathic medical College and hospital |
| Address |
Department of practice of medicine,Nehru homoeopathic medical College and hospital B Block Defence Colony New Delhi -110024
South
DELHI
110024
India |
| Phone |
8851003647 |
| Fax |
|
| Email |
rakeshthakkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Singh |
| Designation |
Junior Resident |
| Affiliation |
Nehru homoeopathic medical College and hospital |
| Address |
Department of practice of medicine,Nehru homoeopathic medical College and hospital B Block Defence Colony New Delhi -110024
South
DELHI
110024
India |
| Phone |
9013078361 |
| Fax |
|
| Email |
akhilesh27061997@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nehru homoeopathic medical College and hospital ,B Block, Defence Colony, New Delhi 110024 |
|
|
Primary Sponsor
|
| Name |
Dr Akhilesh Singh |
| Address |
Nehru homoeopathic medical College and hospital, B Block, Defence Colony, New Delhi -110024 |
| 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 |
| Dr Akhilesh Singh |
Nehru homoeopathic medical College and hospital |
OPD and IPD, Department of practice of medicine,B block, Defence Colony, New Delhi -110024
South
DELHI |
9013078361
akhilesh27061997@yahoo.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: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of cervical
spondylosis with X-Ray grading I to IV according to Kellgren –Lawrence
Classification |
|
| ExclusionCriteria |
| Details |
1. Patients with serious systemic ailments such as rheumatic
disease , malignancies , neurological and metabolic
conditions.
2. Patients under other medication for the same complaint
3. Patients taken steroid injection in past 2 weeks
4. Patients taking medications with analgesics and
anti-inflammatory effect for other conditions
5. Patients with cognitive impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome measure will be improvement in the Oswestry
Neck Disability Index in the follow ups upto a maximum
period of three months. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The outcome measure will be improvement in the Oswestry
Neck Disability Index in the follow ups upto a maximum
period of three months. |
2,6 and 10 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/04/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a prospective single arm observational study on the use fullness of homoeopathic treatment in improving quality of life in 30 patients with cervical spondylosis that will be done in Out and In Patient department of Nehru homoeopathic medical College and hospital, B-Block, Defence Colony, New Delhi 110024.The duration of study will be 1 year .The primary outcome measure will be improvement in the Oswestry Neck disability index which will be recorded every two weeks upto maximum 3 months for each patient. |