| CTRI Number |
CTRI/2024/09/073868 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Ferrum Phos 6X in management of iron deficiency anemia- Placebo controlled study. |
|
Scientific Title of Study
|
Efficacy of Ferrum Phosphoricum 6X in cases of iron deficiency anemia under iron supplementation- A Randomised placebo controlled 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 Khyati Prakash |
| Designation |
Assistant Professor |
| Affiliation |
Ananya College of Homoeopathy, KIRC Kalol |
| Address |
Department of Community Medicine, Ananya College of Homoeopathy, KIRC Campus, Gandhinagar, Gujarat.
Gandhinagar
GUJARAT
382721
India |
| Phone |
9818894729 |
| Fax |
|
| Email |
khyatipraksh2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekanand Yadav |
| Designation |
Professor |
| Affiliation |
Ananya College of Homoeopathy, KIRC Kalol |
| Address |
Department of Community Medicine, Ananya college of Homoeopathy, KIRC Campus, Kalol, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
7987122851 |
| Fax |
|
| Email |
vkyadavhom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khyati Prakash |
| Designation |
Assistant Professor |
| Affiliation |
Ananya College of Homoeopathy, KIRC Kalol |
| Address |
Department of Community Medicine, Ananya college of Homoeopathy, KIRC Campus, Kalol, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
9818894729 |
| Fax |
|
| Email |
khyatipraksh2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adarsh Homoeopathic Hospital, KIRC Campus, Kalol,Gandhinagar, Gujarat. Pin code 382721 |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [NONE] |
|
|
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 Khyati Prakash |
Adarsh Homoeopathic Hospital, KIRC Kalol. |
OPD (Medicine) Adarsh Homoeopathic Hospital, KIRC Campus, Kalol, Gandhinagar, Gujarat. 382721
Gandhinagar
GUJARAT |
9818894729
khyatipraksh2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
ferrom phos 6x with iron supplements |
Group A- cases will be administered Ferrum phos 6X with iron supplements.
Group B - cases will be administered only iron supplements.
Group C – cases will be administered only Ferrum phos. 6X
|
| Intervention |
Ferrum phos 6x
TDS FOR 2 WEEKS (TILL 6 MONTHS)
FOLLOW UP AT EVERY 2 WEEKS |
Group A- cases will be administered Ferrum phos 6X with iron supplements.
Group B - cases will be administered only iron supplements.
Group C – cases will be administered only Ferrum phos. 6X
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Well diagnosed cases of iron deficiency anemia on the basis of sign and symptoms and blood analysis.
Patients giving voluntary consent to participate.
Patient with Hb level between 6.5-8gm%.
|
|
| ExclusionCriteria |
| Details |
(a) Pregnant and Lactating women.
(b) Patient taking any other homoeopathic treatment.
(c) Patients with history of Malaria/ Dengue in last 4 weeks.
(d) Patients with any other types of anemia like sickle cell, thalassemia, megaloblastic anemia, Mal-absorption syndrome)
(e) Severe cases of anemia requiring blood transfusion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hb level |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sympotomatic relief |
6 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2024 |
| 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 Yet Recruiting |
| 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
|
Title: EFFICACY
OF FERRUM PHOSPHORICUM 6X IN CASES OF
IRON DEFICIENCY ANEMIA IN ADULT FEMALES – A PARALLEL ARM RANDOMISED STANDARD
TREATMENT CONTROLLED STUDY. 1. AIM AND OBJECTIVE:
1.1 Aim:
To assess the
effectiveness of Ferrum Phos 6X in cases of iron deficiency anemia.
1.2 Objectives:
·
To assess the effectiveness of Ferrum Phos 6X in
cases of iron deficiency anemia on basis of change in Hb%.
·
To assess the effectiveness of add on Ferrum phos 6x in cases of iron deficiency
anemia under iron supplementation on basis of change in Hb%. |