| CTRI Number |
CTRI/2025/02/080690 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic management of anaemia with Ferrum Phos |
|
Scientific Title of Study
|
TO ELICIT THE EFFICACY OF FERRUM PHOSPHORICUM 6X IN MANAGEMENT OF IRON DEFICIENCY ANAEMIA IN YOUNG FEMALES - A RANDOMISED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Channagouda S Ramagondi |
| Designation |
INTERNEE |
| Affiliation |
KLE Homoeopathic Medical College |
| Address |
KLE Homoeopathic medical college,
Yellur Road,
Belagavi,
Karnataka,
India
KLE Homoeopathic medical college,
Yellur Road,
Belagavi,
Karnataka,
India
Belgaum
KARNATAKA
590005
India |
| Phone |
8861523864 |
| Fax |
|
| Email |
chetan9449422618@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. RINKU PORWAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KLE Homoeopathic Medical College |
| Address |
KLE Homoeopathic medical college and hospital
Yellur Road,
Belagavi.
Karnataka.
India.
KLE Homoeopathic medical college and hospital,
Yellur Road,
Belagavi.
Karnataka.
India.
Belgaum
KARNATAKA
590005
India |
| Phone |
9916987766 |
| Fax |
|
| Email |
romagporwal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Channagouda S Ramagondi |
| Designation |
INTERNEE |
| Affiliation |
KLE Homoeopathic Medical College |
| Address |
KLE Homoeopathic medical college and hospital,
Yellur Road,
Belagavi.
Karnataka.
India.
KLE Homoeopathic medical college and hospital,
Yellur Road,
Belagavi.
Karnataka.
India.
Belgaum
KARNATAKA
590005
India |
| Phone |
8861523864 |
| Fax |
|
| Email |
chetan9449422618@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research
JNMC Campus, Nehru Nagar, Belagavi - 590 010,
Karnataka,
India. |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education (KAHER) |
| Address |
Nehru Nagar
Belagavi- 590010
Karnataka,
India |
| Type of Sponsor |
Private medical college |
|
|
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 Rinku Porwal |
KLE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF FORENSIC MEDICINE AND TOXICOLOGY
ROOM NO. 154, 4TH FLOOR
KLE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, YELLUR ROAD, BELAGAVI. KARNATAKA.
Belgaum
KARNATAKA |
9916987766
romagporwal1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Universitys Shri B.M.Kankanawadi Ayurved Mahavidyalaya & KLE Ayurved Hospital, Shahapur, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (2) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Iron Supplementation. |
Ferrum Phosphoricum 6X (2-0-2) for the period of 03 months. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Female |
| Details |
Haemoglobin percentage 08-11 gm% |
|
| ExclusionCriteria |
| Details |
1. Male subjects
2. Female subjects below 14 years of age and above 22 years of age.
3. Subjects with congenital hemolytic disease.
4. Bone marrow depressive cases due to any drugs.
5. Anaemia due to traumatic injury, accidents, poisoning cases or any other terminal illness.
6. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Homoeopathic medicine Ferrum Phosphoricum 6X is able to improve the Haemoglobin in females included in study. |
03 months of ferrum phosphoricum 6X tablet (2-0-2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Homoeopathy as a potential alternative treatment option for Iron deficiency Anaemia |
At the end of study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Step 01: Subjects with signs and symptoms of Anaemia are screened. Step 02: Subjects with signs and symptoms of anaemia are investigated for Iron Profile [Complete Blood Count, Serum Iron, Serum Ferritin, Total Iron Binding Capacity (TIBC)]. Subjects with Hb below 11gm% are included. Step 03: Subjects selected are given Ferrum Phosphoricum 6X (2-0-2) is given for 03 months. Step 04: Post treatment, subjects are investigated for Iron Profile [Complete Blood Count, Serum Iron, Serum Ferritin, Total Iron Binding Capacity (TIBC)]. |