| CTRI Number |
CTRI/2024/04/066513 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic management in Iron deficiency anemia |
|
Scientific Title of Study
|
A study to assess the comparative efficacy of Ferrum Phosphoricum 3X and Individualized homoeopathic medicine in the management of Iron deficiency anemia
|
| 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 Arshi |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Materia Medica
State National Homoeopathic Medical College And Hospital
Viraj Khand-1 Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7669007966 |
| Fax |
|
| Email |
arshiverkhiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archna |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Materia Medica
State National Homoeopathic Medical College And Hospital
Viraj Khand-1 Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8802630777 |
| Fax |
|
| Email |
archnashakya1988@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshi |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Materia Medica
State National Homoeopathic Medical College And Hospital
Viraj Khand-1 Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7669007966 |
| Fax |
|
| Email |
arshiverkhiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College And Hospital Viraj Khand-1 Gomtinagar Lucknow Uttar Pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Arshi |
| Address |
State National Homoeopathic Medical College And Hospital Viraj Khand-1 Gomtinagar Lucknow Uttar Pradesh 226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arshi |
State National Homoeopathic Medical College And Hospital |
Department of Materia Medica
Lucknow
UTTAR PRADESH |
7669007966
arshiverkhiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of State National Homoeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrum Phosphoricum 3X |
Ferrum Phosphoricum 3X will be given to the patients selected by computer generated randomization. Doses and duration of repetition will be according to the necessity of the case. Route of administration will be oral. |
| Intervention |
Homoeopathic individualized medicine |
Homoeopathic individualized medicine will be selected based on the totality of symptoms and will be given to the patients selected by computer generated randomization.
Potency selection based on the susceptibility of the patient, minimum dose will be given. Repetition based on the severity of the disease.
Route of administration-oral.
In addition to this, placebo will be given to the patients in this group till final assessment of the case. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with clinical symptoms of iron deficiency anemia
2)Patient having hemoglobin level ≤ 11.9g/dl and ≥ 8g/dl
3) Patient having Serum Ferritin less than 30 microgram/l
4)Patients providing written informed consent. |
|
| ExclusionCriteria |
| Details |
1)Patients with hemoglobin levels ≤ 7.9 g/dl (severe anemia)
2)Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life- threatening infections affecting quality of life or any vital organ failure.
3)Pregnancy and lactation
4)Substance abuse and/or dependence
5)Self-reported immune-compromised state
6)Patients who are already enrolled in some other study.
7)Patient unwilling for inclusion in the study and those who are not able to come for follow-up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Hb% and serum ferritin level |
At baseline and after every 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue severity scale (FSS) scores |
At baseline and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/05/2024 |
| 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="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
|
Iron deficiency anemia stands out as the predominant cause of anemia globally. Individuals affected by this condition frequently experience non-specific symptoms like fatigue and dyspnea on exertion and it can significantly impact daily activities of individual. Approximately 30% of the global population is affected by anemia, and half of these cases are attributed to iron deficiency. Iron deficiency anemia occurs when iron losses or physiological requirements exceed absorption. This study will compare the effectiveness of homoeopathic individualized medicine and Ferrum Phosphoricum-3X in the management of Iron deficiency anemia. 60 patients will be enrolled and will be categorized into two groups of 30 patients each. One group will receive Ferrum Phosphoricum-3X while the other will be given homoeopathic individualized medicine based on the totality of symptoms. Each patient will be evaluated regularly. The result will be assessed through the level of hemoglobin and serum ferritin. |