| CTRI Number |
CTRI/2026/01/100730 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic management in Iron deficiency anemia by using Manganum aceticum 30 potency |
|
Scientific Title of Study
|
A randomized placebo controlled trial to study the efficacy of Manganum aceticum 30C in Iron deficiency anemia on iron parameters and haemogram |
| 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 Bathula Sandhya |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD NO 6 Department Practice OF Medicine JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Village Palamakul PO Hyderabad
Hyderabad
TELANGANA
509325
India |
| Phone |
8639334244 |
| Fax |
04023470444 |
| Email |
15bathulasandhya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kalyani Koya |
| Designation |
Associate Professor |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD NO 6 Department Practice Of Medicine JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Village Palamakul PO Telangana Hyderabad
Hyderabad
TELANGANA
509325
India |
| Phone |
8007661260 |
| Fax |
04023470444 |
| Email |
dr.kalyanikoya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bathula Sandhya |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD NO 6 Department Practice OF Medicine JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Village Palamakul PO Telangana Hyderabad
Hyderabad
TELANGANA
509325
India |
| Phone |
8639334244 |
| Fax |
04023470444 |
| Email |
15bathulasandhya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIMS Homoeopathic Medical College and Hospital |
| Address |
JIMS Homeopathic Medical College and Hospital Sriramnagar Muchintal Hyderabad Telangana 509325 |
| 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 Bathula Sandhya |
JIMS Homeopathic Medical College and Hospital |
OPD NO 6 Department Practice OF Medicine JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Village Palamakul PO Hyderabad Telangana
Hyderabad
TELANGANA |
08639334244
04023470444
15bathulasandhya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECJIMS |
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 |
Manganum aceticum 30C |
4 medicated globules of number 20 size will be prescribed twice daily once a week for 6 months |
| Comparator Agent |
Placebo |
4 placebo globules of number 20 size will be prescribed twice daily once a week for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases that have been diagnosed as iron deficiency anemia having moderate and mild levels through iron parameters serum ferritin less than 15 to 30 serum iron less than 55
serum transferrin greater than 3 TIBC greater than 400 and hemoglobin 8 to 12
Subjects of age group between 18 years to 60 years
Subjects of all the genders |
|
| ExclusionCriteria |
| Details |
subjects with other systemic illnesses like Hypertension Diabetes mellitus Bleeding
disorders Renal disorders Trauma
Subjects who are on Iron supplementations
Cases with antenatal follow ups |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Significant changes in levels of serum iron parameters baseline and end
of the study in a duration of 6 months |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The significant changes in levels of Haemogram for every 2 months in
the duration of 6 months study period |
baseline 2nd month 4th month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 |
|
Date of First Enrollment (India)
|
16/01/2026 |
| 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="2"
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 (IDA) remains the most prevalent nutritional disorder globally and a major public health concern in India, particularly among women and children. Conventional iron therapy, though effective, is frequently associated with gastrointestinal side effects and poor adherence, highlighting the need for safer and more tolerable alternatives. Homoeopathy offers potential therapeutic options, and Manganum aceticum is traditionally indicated in anemic conditions associated with destruction of red blood corpuscles. This randomized, single-blinded, placebo-controlled clinical trial aims to evaluate the efficacy of Manganum aceticum 30C in improving iron parameters and haemogram findings in IDA patients over six months. Seventy-six participants meeting inclusion criteria will be randomized into two groups—Group A receiving Manganum aceticum 30C with standardized diet, and Group B receiving placebo with standardized diet. Outcome measures include serum iron, ferritin, TIBC, transferrin, hemoglobin, and RBC count assessed at baseline, periodic intervals, and study completion. Statistical analysis will determine intra-group and inter-group differences. The study seeks to establish whether Manganum aceticum 30C can offer a significant therapeutic benefit in IDA and provide an effective, well-tolerated complementary approach to existing management |