| CTRI Number |
CTRI/2024/02/062641 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Ferrum phosphoricum in Anaemia |
|
Scientific Title of Study
|
Effectiveness of Ferrum phosphoricum 6x in Increasing Haemoglobin Levels in Anaemia among the Women of Reproductive Age Group: A comparative 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 |
Madhumita Sadhukhan |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy,
Room no: OPD 5,
Department: Clinical Research,
50, Rajendra Chatterjee Road
Kolkata.
North Twentyfour Parganas WEST BENGAL 700035 India |
| Phone |
9331866008 |
| Fax |
|
| Email |
dr.msadhukhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Madhumita Sadhukhan |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy,
Room no: OPD 5,
Department: Clinical Research,
50, Rajendra Chatterjee Road
Kolkata.
North Twentyfour Parganas WEST BENGAL 700035 India |
| Phone |
9331866008 |
| Fax |
|
| Email |
dr.msadhukhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Madhumita Sadhukhan |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy,
Room no: OPD 5,
Department: Clinical Research,
50, Rajendra Chatterjee Road
Kolkata.
North Twentyfour Parganas WEST BENGAL 700035 India |
| Phone |
9331866008 |
| Fax |
|
| Email |
dr.msadhukhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Institutional Area, Opposite D
Block, Janakpuri, New Delhi: 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional Area, Opposite D Block, Janakpuri, New Delhi: 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Madhumita Sadhukhan |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
Room no: OPD 5,
Department: Clinical Research,
50, Rajendra Chatterjee Road, Kolkata 700035. North Twentyfour Parganas WEST BENGAL |
9331866008
dr.msadhukhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D53||Nutritional anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine, Ferrum Phosphoricum |
Ferrum phos 6X will be given on the basis of the presence of an indication of the medicine Ferrum phosphoricum in patients with anemia. All the patients will be given Ferrum phos 6X, 4 tablets OD for 3 months. Trial medicine i.e. Ferrum phos 6X, shall be procured from a GMP-compliant pharmaceutical firm approved by the Council. Medicines will be dispensed in the form of tablets.
Consideration of inclusion of the patients as per the presence of any 5 symptoms amongst the 1st and 2nd grade symptoms from The Guiding Symptoms of Our Materia Medica By Constantine Hering.
Duration of intervention is 3 months |
| Comparator Agent |
Homoeopathic Medicine, Ferrum Phosphoricum |
Ferrum phos 6X will be given without considering the indication of the medicine Ferrum phosphoricum and will be given as specific to the patients with anemia. All the patients will be given Ferrum phos 6X, 4 tablets OD for 3 months. Trial medicine i.e. Ferrum phos 6X, shall be procured from a GMP-compliant pharmaceutical firm approved by the Council. Medicines will be dispensed in the form of tablets. Consideration of inclusion of the patients as per the presence of any 5 symptoms amongst the 1st and 2nd grade symptoms from The Guiding Symptoms of Our Materia Medica By Constantine Hering. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female aged 18-45 years,
2. Diagnosed case of Anaemia with Haemoglobin level more than or equal to 8 gm per dl to less than 12 gm per dl
3. Willing to give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients unable to give informed consent or unwilling to take part in the study.
2. Pregnant and lactating mother
3. Patients who are self-reported immune-compromised.
4. Patients with any self-reported haemoglobinopathies like Thalasaemia, Sickle cell anemia etc.
5. Patients suffering from Anaemia with chronic illnesses like diabetes, cardiac complications, renal failure etc.
6. Patient with diagnosed case of inadequate organ and bone marrow functioning due to aplasia and or malignancy.
7. Patient with psychiatric disorder and or history of substance abuse
8. Patient under homoeopathic treatment for any chronic disease within last 1 month.
9. Patient who are already under Iron supplementation in last 1 month before the enrollment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemoglobin level |
At the baseline and at the end of each month till 3 months of follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum biochemical markers, Serum ferritin, Transferrin, TIBC |
At the baseline and at the end of 3rd month |
| Quality of life SF36 Score |
At the baseline and at the end of every months till 3 months |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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 2 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="0" 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
|
Anemia is a
condition where the number of RBCs or their oxygen-carrying capacity decreases
to the extent to meet the physiologic needs, and is conventionally taken as a
hemoglobin (Hb) value of less than two standard deviations (SD)than the median
value for healthy matched population by age, sex, altitude, smoking, and
pregnancy status. Among the various causes, nutritional deficiency, especially iron deficiency, is the most common cause of anemia. Regarding the strategies
for correcting IDA (Iron Deficiency Anaemia) at the community level, we have a few
options available alone or in combination: education combined with dietary
modification or diversification, or both, to improve iron intake and
bioavailability; iron supplementation and iron fortification or bio-fortification
of foods. Oral iron supplementation has limitations, including side effects, non-compliance, and taking a longer time to correct anemia. Homoeopathy
can bridge the gap to reduce the burden of IDA due to its acceptability in the general population and cost-effectiveness. Though there are some encouraging
pre-clinical as well as clinical trial, evidences favoring the role of Ferrum
phosphoricum in IDA, but studies with proper methodology, larger sample sizes and proper statistical evaluation still miniscule in this subject to draw any definite
conclusion. Therefore, a double-blind, randomized controlled trial in a
pragmatic setup is required to evaluate the efficacy of FP in IDA over the
placebo. But before that, it requires clear clarification whether FP will be useful
in anaemia (specific) universally or only when applied according
to the indications of this medicine. |