| CTRI Number |
CTRI/2024/06/068286 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Treatment of Iron Deficiency Anaemia of Reproductive Females |
|
Scientific Title of Study
|
Therapeutic effects of Lecithinum on red blood cells and haemoglobin concentration in iron deficiency anaemia of reproductive females: A randomized, double blind placebo- controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1308-5184 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RUPALI BHADURI |
| Designation |
Reader, Department of Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RUPALI BHADURI |
| Designation |
Reader, Department of Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RUPALI BHADURI |
| Designation |
Reader, Department of Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital, 265,266 APC Road, Kolkata 700009, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital, 265, 266 APC Road, Kolkata 700009, West Bengal, India |
| Type of Sponsor |
Government 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 RUPALI BHADURI |
The Calcutta Homoeopathic Medical College and Hospital |
OPD number 3, 16, 19, 21 of Dept of Medicine, Materia Medica, Gynaecology and Organon at The Calcutta Homoeopathic Medical College and Hospital, 265-266 Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL |
9571806989
drrupalibhaduri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government of West Bengal, The Calcutta Homoeopathic Medical College and Hospital, 265-266, A.P.C Road, Kolkata-700009 |
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 |
| Intervention |
Homoeopathic Treatment with Lecithinum along with Concomitant Care |
Intervention is planned as administering indicated
homoeopathic medicines as decided to the case or
condition. Each dose to be taken orally on clean tongue
in empty stomach; dosage and repetition depending upon the individual requirement of
the cases. Patients will be advised to refrain from handling the globules or from eating,
drinking, smoking, or brushing teeth within 30 minutes of taking the globules and will
be asked to suck the globules rather than simply swallowing those. Single individualized
medicine will be prescribed on each occasion taking into account presenting symptoms
totality, clinical history details, constitutional features, miasmatic expressions
repertorization using HOMPATH® and RADAR® software when required with due
consultation of Materia Medica and due consensus among three homoeopaths. All the
medicines and sundry items will be procured from a Good Manufacturing Practice
(GMP) certified firm. Duration of therapy: 3months. |
| Comparator Agent |
Identical looking Placebo with Concomitant Care |
This group will receive placebo, identical in appearance
with the verum. Each dose to be taken orally on clean tongue in empty stomach; dosage and
repetition will be maintained depending upon the individual requirement of the cases.
All sundry items will be procured from a Good Manufacturing Practice (GMP) certified
firm. Duration of therapy: 3months. Both medicines and placebos will be re-packed in
identical glass bottles and labelled with code, name of medicines, potency, and will be
dispensed according to the random number list. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. Reproductive age group: 18-49 years.
2. Patients suffering from iron deficiency anaemia confirmed by Hb% 7-12 gm/dl and serum ferritin level less than 30 ng/mL.
3. Only female sexes
4. Person not taking any other homoeopathic medicines for last 4 weeks.
5. Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
6. Literate participant able to read and write in English, Hindi or Bengali
7. Participants providing with written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with haemoglobin less than 7 gm/dL (severe anaemia)
2. Diagnosed case of unstable mental or physical illness or other uncontrolled systemic illness or life- threatening infections (e.g., malignancy) affecting quality of life or any vital organ failure.
3. Pregnant, puerperal and lactational women
4. Any substance abuses
5. Self-reported immune – compromised state
6. Patients who are too sick for consultation
7. Simultaneous participation of any other clinical trials
8. Undergoing homoeopathic treatment for any chronic disease within last 6 month
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the hemoglobin percentage through complete hemogram in each sample |
Hemoglobin percentage at baseline and every months, till 3 months in each sample |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the structural change in RBC, RBC count, and to measure Fatigue Severity using Fatigue Severity Score (FSS) |
2 years or till the sample sized achieved |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="2"
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
|
The World Health Organization defines anaemia as a condition in which the number of red cells or their oxygen-carrying capacity is insufficient to meet physiological requirements. Rates of iron deficiency anaemia in women of childbearing age exceed this due to menstruation and pregnancy-related blood loss. While lecithin has a significant effect in increasing red blood cell (RBC) and haemoglobin (Hb) percentages, but our extensive search on lecithin studies revealed limited available data. Therefore, we aim to conduct an randomized research study at The Calcutta Homoeopathic Medical College and Hospital, with targeted sample size of 240, to investigate the potential significant improvement in anemic women through homoeopathic medicine lecithinum. Primary outcome is to observe the hemoglobin percentage and secondary outcopme is to observe the structural change in RBC, RBC count, and to measure Fatigue Severity using Fatigue Severity Score (FSS). |