| CTRI Number |
CTRI/2021/08/035865 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on effectiveness of Homoeopathic Medicines in the management of neck pain , pins and needles sensation in hands |
|
Scientific Title of Study
|
A Study on effectiveness of Homoeopathic Medicines in the management of cervical radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Meher |
| Designation |
Pg scholar |
| Affiliation |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College |
| Address |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College Dhankawadi Pune Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7276785242 |
| Fax |
|
| Email |
neha.m.2429@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Nadgauda |
| Designation |
Assistant professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College Dhankawadi Pune Maharashtra 411043 |
| Address |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College Dhankawadi Pune Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9970153078 |
| Fax |
|
| Email |
dr.samirn2374@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Nadgauda |
| Designation |
Assistant professor |
| Affiliation |
Assistant professor |
| Address |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College Dhankawadi Pune Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9970153078 |
| Fax |
|
| Email |
dr.samirn2374@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth homoeoathic college |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College |
| Address |
Bharati Vidyapeeth Deemed University Homoeopathic Medical College Dhankawadi Pune Maharashtra 411043 |
| 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 |
| Neha Meher |
BVDUHMC |
Department of Medicine, Bharati Vidyapeeth Deemed University Homoeopathic Medical College Dhankawadi Pune Maharashtra 411043
Pune
MAHARASHTRA |
7276785242
neha.m.2429@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee B.V.D.U.H.M.C, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines along with standard care |
Homoeopathic medicines will be given tothebgroup of patients as an add on to standard treatment.following individualisation medicines will be selected on keeping in view pathological aspects of diseases, dose and potency will be according to frequency ,intensity and duration of signs and symptoms,repetation of doses will vary from case to case bases considering disease state and vitality of patient,range of potency will be from 30 200 1 M etc will be used
Dosage. As per required according to the severity of case
Frequency as per required according to the case
Route of administration medicine will be prescribed orally
Duration of therepy 3 months to six months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. The samples will be selected from the age group in between 15 to 65 yrs
2. Diagnosed cases with MRI and clinical diagnosis
3.The diagnostic criteria is mainly based on clinical history, presentation,
examination findings.
4.Grades 0 to 2 are included gradation according to pfirrmann grading) |
|
| ExclusionCriteria |
| Details |
1. The study does not involve patient having cervical radiculopathy with
myelopathy
2. Grades 3 is excluded (gradation according to pfirrmann grading)
3.Cervical cancers are excluded.
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Cervical radiculopathy can be assessment critereria.
Proper case history of the patient will be taken with the help of case poforama and
symptoms will be recorded.
3 types of scales will be used for the assesment of cervical radiculopathy.(appendix
1) By using these scales the severity of the symptoms would be recorded..
|
Follow up will be taken after 15 days of prescription
In total 6 followup will be taken in total 3 months are required for final result of each case |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce intensity and to find the effectiveness of Homoeopathic Medicines in treatment of cervical radiculopathy before and after treatment given |
1. First follow-up will be on the 7th day of starting
the treatment.
2. Second, follow-up and onward will be after 15
days and according to the need of the patient. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/08/2021 |
| 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
|
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Brief Summary
|
Cervical radiculopathy is the damage or disturbance of nerve function that results if one of the nerve roots near the cervical vertebrae is compressed. Damage to nerve roots in the cervical area can cause pain and the loss of sensation along the nerve’s pathway into the arm and hand, depending on where the damaged roots are located.
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