| CTRI Number |
CTRI/2024/11/076831 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lymphadenopathy and Homoeopathy |
|
Scientific Title of Study
|
Role of Individualized Homoeopathic Medicine in Cervical Lymphadenopathy in children-Pilot , Open-label study |
| 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 Renu Mittal |
| Designation |
Research Officer/ Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-block, New Delhi- 110058
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
28521060 |
| Email |
renumittal8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer/ Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-block, New Delhi- 110058
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
28521060 |
| Email |
renumittal8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer/ Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-block, New Delhi- 110058
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
28521060 |
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 institutional area, opposite d block, Janakpuri, New Delhi, India, Pin code- 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri |
| Type of Sponsor |
Research institution |
|
|
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 Shashi Giri |
Homoeopathic Treatment Centre (OPD), Safdarjung Hospital, New Delhi |
Homoeopathic Treatment Centre, Room no.139 and 140, C wing, 1st Floor, New OPD Building, safdarjung Hospital, New Delhi
South West
DELHI |
9681423136
shashi462@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R221||Localized swelling, mass and lump,neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Individualized homoeopathic medicines obtained after case taking will be prescribed via oral route of administration for duration of 6 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children between 5 to 17 years,Sex: Both male and female,Single or multiple enlarged cervical lymph nodes or enlarged unilateral or bilateral cervical lymph node,
At least 1 cervical lymph node should be more than 1 cm or palpable,Assent of children and consent of parents |
|
| ExclusionCriteria |
| Details |
Children suffering from Pulmonary Tuberculosis, Hodgkin’s lymphoma, malignancy, autoimmune disease, severe pathological changes like matting, ulceration, or abscess formation etc.
Lymph node less than 1cm in size or at any other site such as inguinal or axillary areas |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the number and size of the cervical lymph nodes will be assessed monthly till the end of treatment.
Change in mobility will be assessed monthly till the end of treatment.
Change in consistency will be assessed monthly till the end of treatment.
|
Assessed monthly till end of 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in mobility
Change in consistency |
Assessed monthly till end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a Pilot, Open-label, Interventional study and will be undertaken at the Homoeopathic Treatment centre (OPD),Safdarjung Hospital with an objective to evaluate the effectiveness of individualized homoeopathic medicine in cervical lymphadenopathy in children. The objective is to assess the change in number, location and size of the enlarged cervical lymph nodes. The outcome assessment parameters will be assessed monthly by evaluating the change in number, location, size, mobility and consistency till end of 6 months. |