| CTRI Number |
CTRI/2019/05/019077 [Registered on: 13/05/2019] Trial Registered Retrospectively |
| Last Modified On: |
01/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy for treatment of Iron deficiency anemia in children |
|
Scientific Title of Study
|
Homoeopathic Ferrum Drugs in treatment of Iron Deficiency anemia in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R K Manchanda |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Central Council for Research in Homoeopathy, 61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi
61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
9811014493 |
| Fax |
011-28521060 |
| Email |
rk.manchanda@nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Khurana |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Central Council for Research in Homoeopathy, 61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi
61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
9911127619 |
| Fax |
011-28521060 |
| Email |
anil23101961@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer (H), S-1 |
| Affiliation |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Central Council for Research in Homoeopathy, 61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi
61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
011-28521060 |
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, New Delhi; 61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi–110058 |
|
|
Primary Sponsor
|
| Name |
CCRH |
| Address |
61-65,Institutional Area, Opp.D-Block, Janakpuri, New Delhi–110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmalya Rath |
Dr. D. P. Rastogi Central Research Institute of Homoeopathy, Noida |
Paediatric OPD, Ground Floor, A-1/1, Sector-24, Noida-201301
Gautam Buddha Nagar
UTTAR PRADESH |
9811704560
0120-2411320
drpadmalaya@gmail.com |
| Dr Karunakara Moorthy |
National Homoeopathy Research Institute in Mental Health (NHRIMH) |
Paediatric OPD, Ground Floor, Sachivothamapuram P.O., Kottayam, Kerala State -686 532
Kottayam
KERALA |
8281502571
04812432238
drjaiguru@gmail.com |
| Dr Umakant Prusty |
Regional Research Institute Guwahati |
Paediatric OPD, Ground Floor, Old Building, NEIARI (Ayurvedic Campus)
Barsojai (Bhetapura),P.O. Beltola, Guwahati- 781028
Barpeta
ASSAM |
09485025977
druprusty@gmail.com |
| Dr Ojit Singh |
Regional Research Institute Imphal |
paediatric OPD, Ground Floor, New Checkon, Maring Lane Opp. Tribal Colony, Imphal East – 795001, Manipur
Imphal East
MANIPUR |
8974003895
03852400997
rriimphal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrum metallicum 3X |
Homoeopathic medicine included in HPI. Two tablets 100 mg each twice a day will be prescribed to all children identified with anemia for a period of 3 months. Edit || Delete
|
| Intervention |
Ferrum Phosphoricum 3X |
Ferrum phosphoricum 3X homoeopathic medicine (HPI Volume I).Two tablets of 100mg each twice a day will be prescribed to all children identified with anemia for a period of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Hemoglobin levels ≤ 11.9 gm% and≥ 8 gm%; Serum ferritin levels below 15µg/L ; Low mean corpuscular volume (less than 87 fl)
|
|
| ExclusionCriteria |
| Details |
Children with Raised CRP levels; Children who have had malaria within 6 weeks prior to the enrollment; Children having worm infestations; Children with reduced Vitamin B12 levels; Children with concurrent heart, liver, renal systemic conditions; Children where parents refuse consent or child refuses assent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin levels |
At baseline and at end of 3 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Red cell count, PCV, MCV, MCH and MCHC; Change in symptomatology of patients; Incidence of any adverse events during the period of treatment |
At baseline and fortnightly follow ups for 03 months. |
|
|
Target Sample Size
|
Total Sample Size="640"
Sample Size from India="640"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2015 |
| Date of Study Completion (India) |
24/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Khurana A, Mittal R, Rath P, Moorthy K, Taneja D, Singh U, Mishra K, Manchanda RK. Ferrum phosphoricum 3X and Ferrum metallicum 3X in the treatment of iron deficiency anaemia in children: Randomized parallel arm study. Indian J Res Homoeopathy 2020;14:171-8 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted with an objective to identify the action of Ferrum phosphoricum 3X, Ferrum metallicum3X in iron deficiency anemia. 160 patients in the age group of 12 -14 years of age with Hemoglobin levels ≤ 11.9 gm% and≥ 8 gm%, serum ferritin levels from 10-12µg/L and low mean corpuscular volume (less than 87 fl) will be enrolled in the study. Study is a pilot prospective parallel group, multi-centric single blind randomized trial, where Ferrum drugs (Ferrum phosphoricum 3X, Ferrum Metallicum 3X) will be prescribed as 2 tablets (100 mg), twice a day to children diagnosed with mild to moderate iron deficiency anemia for a period of 3 months. Outcome will be measured in terms of change in Change in hemoglobin levels after 3 months of treatment and changes in other hematological parameters related to anemia i.e. serum ferritin, serum iron, serum total iron binding capacity. |