Effectiveness of Individualized Homoeopathic Medicine in Cervical Lymphadenopathy in children- Pilot, Open label study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 4
- Primary Endpoint
- Change in number,location & size of the cervical lymph nodes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 5.00 Year(s) to 17.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in number,location & size of the cervical lymph nodes
Time Frame: Assessed fortnightly till end of 6 months
Secondary Outcomes
- Change in mobility(Change in consistency)