| CTRI Number |
CTRI/2025/08/093063 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Homoeopathic Medicine Ferrum metallicum 200 on Iron Deficiency anemia among Women of reproductive Age Group (15-50) with Assessment of Serum Ferritin Level |
|
Scientific Title of Study
|
Effect Of Homoeopathic Medicine Ferrum metallicum 200 On Iron Deficiency anemia Among Selected Women Of Reproductive Age Group (15-50) With Assessment of Serum Ferritin Level – An Expository 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 D Augustin jebaraj |
| Designation |
Associate proffessor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Ph. D Scholar, Dept. of practice of medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
09443432881 |
| Fax |
|
| Email |
draugustinmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N V Sugathan |
| Designation |
Principal, Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Dept. Of Practice of medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
09443558786 |
| Fax |
04651279448 |
| Email |
drnvsugathan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandraja C V |
| Designation |
Associate proffessor |
| Affiliation |
JIMS Homoeopathic medical college |
| Address |
Dept of Research methodology and Biostatistics, JIMS Homoeopathic medical college Muchintol Sriram nagar Shamshabad
Hyderabad
TELANGANA
509325
India |
| Phone |
09894132132 |
| Fax |
|
| Email |
chandrajarathish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District. 629161 |
| Type of Sponsor |
Research institution |
|
|
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 D Augustin jebaraj |
Sarada Krishna Homoeopathic Medical College Hospital |
Room no. , Research section, Sarada Krishna Homoeopathic Medical College Hospital, Kulasekharam
Kanniyakumari
TAMIL NADU |
09443432881
draugustinmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Iron deficiency anemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine Ferrum metallicum 200 one dose will be prescribed once in a month for a period of 3 months administered orally |
After Case taking and assessment with laboratory investigation along with serum ferritin measurement, Homoeopathic medicine Ferrum metallicum 200 will be prescribed once in a month, Follow up assessment including laboratory investigation (haemoglobin and serum ferritin) |
| Comparator Agent |
One dose of Individualized homoeopathic medicine will be prescribed once in a month for 3 months which will be administered orally |
After Case taking and assessment with laboratory investigation along with serum ferritin measurement, individualized Homoeopathic medicine will be prescribed once in a month, Follow up assessment including laboratory investigation (haemoglobin and serum ferritin) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion of subjects fulfilling the diagnostic criteria.
Case taking and assessment with laboratory investigation along with serum ferritin measurement |
|
| ExclusionCriteria |
| Details |
Pregnant women, Lactating women, Females before menarche, Females after menopause, Females with dysfunctional uterine bleeding, uterine diseases, intestinal mal absorption, ongoing excessive blood loss, (including ongoing blood donations), inflammatory bowel disease, cancer, chronic congestive cardiac failure, chronic renal failure, chronic liver failure or chronic infectious disease, or hospitalized or ill patients |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Follow up assessment including laboratory investigation (haemoglobin and serum ferritin) in 3 month |
3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement will be evaluated according to the FACIT F SCALE every month |
Every month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0"
Months="6"
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
|
Study group 1. Detailed case taking and recording of problems in standardized chronic case record format of SKHMC. 2. Clinical examination with laboratory investigation. 3. Ferrum mettalicum will be given in 200th potency. 4. Observation will be noted by Facit F scale. Control group 1. Detailed case taking and recording of problems in standardized chronic case record format of SKHMC. 2. Clinical examination with laboratory investigation. 3. Prescription is done with reference to standard text book of Materia Medica as well as repertory. 4. The indicated medicine based on symptom similarity will be given in 200th potency. 5. Observation will be noted by Facit F scale. |
|