| CTRI Number |
CTRI/2025/11/097169 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“A study to see how a homeopathic medicine Aletris farinosa helps female who have anemia due to low iron levels.”
|
|
Scientific Title of Study
|
To evaluate the efficacy of Aletris farinosa mother tincture in management of iron deficiency anemia in female- A clinical 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 Nimisha Joshi |
| Designation |
PG Scholar MD Part II |
| Affiliation |
S.S. Agrawal Homoeopathic medical college and hospital, navsari |
| Address |
5th floor, PG division, Department of Homoeopathic Materia Medica, Near Devina park society, Gandevi road, navsari, Gujarat
Navsari GUJARAT 396445 India |
| Phone |
9372251873 |
| Fax |
|
| Email |
n.joshi12296@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mihir Upadhyay |
| Designation |
Associate Professor of Homoeopathic materia medica |
| Affiliation |
S.S. Agrawal Homoeopathic medical college and hospital, navsari |
| Address |
5th floor, PG division, Department of Homoeopathic Materia Medica, Near Devina park society, Gandevi road, navsari, Gujarat
Navsari GUJARAT 396445 India |
| Phone |
9879093337 |
| Fax |
|
| Email |
mihiru79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mihir Upadhyay |
| Designation |
Associate Professor of Homoeopathic materia medica |
| Affiliation |
S.S. Agrawal Homoeopathic medical college and hospital, navsari |
| Address |
5th floor, PG division, Department of Homoeopathic Materia Medica, Near Devina park society, Gandevi road, navsari, Gujarat
Navsari GUJARAT 396445 India |
| Phone |
9879093337 |
| Fax |
|
| Email |
mihiru79@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S. Agrawal Homoeopathic medical college and hospital, Navsari |
|
|
Primary Sponsor
|
| Name |
S.S. Agrawal Homoeopathic medical college and hospital, Navsari |
| Address |
Near Devina park society, Gandevi road, Navsari, Gujarat |
| 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 Nimisha Joshi |
S.S. Agrawal Homoeopathic medical college and hospital, Navsari |
Medicine OPD, Ground Floor, Near Devina park society, Gandevi road, navsari, Gujarat Navsari GUJARAT |
9372251873
n.joshi12296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine Aletris farinosa |
Homoeopathic medicine Aletris farinosa will be given to the diagnosed or suspected cases of Iron deficiency Anemia. The dose and repetition of dose will be based on the severity of symptoms. The medicine will be administered by oral route and follow ups will be taken. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Diagnosed cases.
2 Suspected cases. |
|
| ExclusionCriteria |
| Details |
1 Pregnant women.
2 Patients on chemotherapy.
3 Patients not coming for follow up.
4 Paediatric and geriatric group.
5 Patients with complications other than iron deficiency anemia.
6 Acute medical emergency.
7 severe systematic pathologies to be excluded
8 Congenital anomalies and immune-compromised.
9 Patient with severe iron deficiency anaemia with blood transfusion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating the efficacy of Aletris farinosa in Iron deficiency anemia and understanding its effects. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
18/11/2025 |
| 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="1" 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
|
It is a single centred randomised clinical study to understand the efficacy of homoeopathic medicine Aletris farinosa in the cases of iron deficiency anemia of females of age group 15-45 years. The study will be of 12 months of duration and the medicines will be administered based on homoeopathic case taking. Cases will be analysed before and after treatment. The medicine will be given orally in mother tincture form. |