| CTRI Number |
CTRI/2023/10/059236 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy and cervical lymphadenopathy |
|
Scientific Title of Study
|
Effectiveness 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 (Homoeopathy) Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri
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 (Homoeopathy) Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri
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 (Homoeopathy) Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri
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, New Delhi |
|
|
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
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Renu Bala |
Central Research Institute(H), Lucknow |
Room no. 1, General OPD, Central Research Institute(H), Sector 2, Jankipuram Extension, Near Vithouli Crossing, Lucknow
Lucknow
UTTAR PRADESH |
9140570079
hdri_lko@yahoo.com |
| Dr GRC Reddy |
Central Research Unit For Homoeopathy |
Central Research Unit(H) SRABANAM CAMPUS OLD MATERNITY HOSPITAL CAMPUS, TIRUPATI
Kurnool
ANDHRA PRADESH |
9441208007
crutpt@gmail.com |
| Dr Madhumita Sadhukhan |
Dr. Anjali Chatterjee, Regional Research Institute for Homoeopathy, Kolkata |
Room no. 3, General OPD, Dr. Anjali Chatterjee, Regional Research Institute for Homoeopathy,50, Rajendra Chatterjee Road, Alambazar, Kolkata-700035
Kolkata
WEST BENGAL |
9331866008
anjalirrikolkata@gmail.com |
| Dr Ranjit Sonny |
Regional Research Institute for Homoeopathy |
Choto Padhuram Jote, Darjeeling, Siliguri, West Bengal
Darjiling
WEST BENGAL |
9883203656
drranjitsonnymd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
| CENTRAL 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 medicines |
Individualized homoeopathic medicines in centesimal potency will be prescribed as per the principles of Homoeopathy in cases of cervical lymphadenopathy
Individualized homoeopathic medicine along with Silicea 6x (as a supportive medicine) and Tuberculinum 200 (as an intercurrent nosode) will be prescribed to the children who are not responding to only individualized homoeopathic medicines/refractory cases of Tubercular Lymphadenitis. Placebo will be prescribed for first 15 days to every patient.
1st assessment (15 days)- Responders of placebo will receive placebo for next 15 days. Non responders will be prescribed individualised homoeopathic medicines for next 15 days.
2nd assessment(at 1 month)- Responders of placebo and individualised homoeopathic medicines will continue receiving the same for next 2 months. Non responders of both the groups will undergo a FNAC and the Dignosed cases of patients with Tubercular lymphadenitis will be prescribed individualised homoeopathic medicines along with Silicea 6x and Tuberculinum 200 for another 2 months.
3rd asessment (3 months)- again the responders and responders will be scrutenised. Responders will continue receiving placebo/ individualised homoeopathic medicines for another 3 months. Non responders will undergo a case recording again to find out the new similimum and they will be prescribed individualised homoeopathic medicines as per the new totality for another 3 months.
Patients with tubercular lymph nodes will continue receiving the same treatment as mentioned in the 2nd asessment |
| 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
Children on Anti Tubercular Treatment (ATT) in the last 6 months.
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 |
Change in number,location & size of the cervical lymph nodes
|
Assessed fortnightly till end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in mobility
Change in consistency |
Assessed fortnightly till end of 6 months
Assessed fortnightly 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)
|
01/11/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The multicentric, Pilot, Open-label, Interventional Study will be undertaken at the 4 peripheral units of CCRH with an objective to evaluate the effectiveness of individualized homeopathic medicine in cervical lymphadenopathy in children, to assess the change in number, location and size of the enlarged cervical lymph nodes , to assess the effectiveness of the individualized Homoeopathic medicines along with Silicea 6x (as a supportive medicine) and Tuberculinum 200 (as an intercurrent nosode) in children who are not responding to only individualized homoeopathic medicines/refractory cases of Tubercular Lymphadenitis. The outcome assessment parameters will be assessed every fortnightly by evaluating the change in number, location, size,mobility and consistency till end of 6 months. |