FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073298 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment of Iron deficiency anemia associated with Vitamin D deficiency 
Scientific Title of Study   Role of Oleum jecoris aselli 3x in Iron deficiency anemia associated with Hypovitaminosis D – a single arm prospective 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 Sowndarya S 
Designation  Post Graduate scholar, Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  National Homoeopathy Research Institute in Mental Health, Satchivothamapuram (P.O.), Kurichy

Kottayam
KERALA
686532
India 
Phone  9789440080  
Fax    
Email  sowndarya3097@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R S Krishneswari 
Designation  Associate Professor, Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  National Homoeopathy Research Institute in Mental Health, Satchivothamapuram (P.O.), Kurichy

Kottayam
KERALA
686532
India 
Phone  8903255833  
Fax    
Email  krishneswarirs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R S Krishneswari 
Designation  Associate Professor, Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  National Homoeopathy Research Institute in Mental Health, Satchivothamapuram (P.O.), Kurichy

Kottayam
KERALA
686532
India 
Phone  8903255833  
Fax    
Email  krishneswarirs@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental Health 
 
Primary Sponsor  
Name  Dr Sowndarya S 
Address  National Homoeopathy Research Institute in Mental Health, Satchivothamapuram (P.O.), Kurichy, Kottayam, Kerala 686532  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sowndarya S   National Homoeopathy Research Institute in Mental Health  Outpatients and Inpatients Department, Peripheral centers, and camps conducted by Department of Medicine of National Homoeopathy Research Institute in Mental Health, Satchivothamapuram P O ,Kurichy
Kottayam
KERALA 		 9789440080

sowndarya3097@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee - National Homoeopathy Research Institute in Mental Health, Kottayam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (2) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  OLEUM JECORIS ASELLI  All the patients will be prescribed with Oleum jecoris aselli 3X (25gm bottle from SBL), 2 tablets in number, twice daily for the follow-up period of 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients from 18 to 60 years of age and both genders.
2.Patients with Hemoglobin level 8 to 12g/dl in females and 8 to 13g/dl in males and Serum ferritin level less than 30µg/L.
3.Patients with 25[OH]D level less than 50 nmol/L (20 ng/mL).
 
 
ExclusionCriteria 
Details  1.Patients with severe anemia with Hemoglobin level less than 8g/dl.
2.Patients with other types of anemia.
3.Patients who are already taking any vitamin D or iron supplementation.
4.Pregnant and lactating women.
5.Patients with other known severe systemic illnesses like uncontrolled diabetes, Malignant Hypertension, Severe cardiac diseases, and Malignancies.
6.Immuno-compromised patients- HIV/AIDS, TB. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in Hemoglobin level  Every month till the conclusion of study (6th month) 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the serum ferritin level and 25[OH]D level   Baseline and at the conclusion of the study(6th month) 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 3 
Date of First Enrollment (India)   03/09/2024 
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  

This study is a single arm, prospective clinical interventional study to determine the role of Oleum jecoris aselli 3X in iron deficiency anemia associated with Hypovitaminosis D that will be conducted by considering the patient presenting with symptoms like weakness, muscle cramps, joint pains, hairfall and other features of IDA and Hypovitaminosis D consulting the outpatient and inpatient department, peripheral centers, special camps of National Homoeopathy Research Institute in Mental Health, Kottayam.The primary outcome measure will the changes in the hemoglobin level, assessed every month. The secondary outcome measures will be the changes in the serum ferritin level and 25[OH]D level, assessed before and after treatment. Liver function tests will be done once in 3 months to check for the toxicological effects(if any) after repeated administration of medicine in 3X potency.This study aims to make the efforts to offer possibilities for future research in identifying the role of Oleum jecoris aselli 3X in the management of iron deficiency anemia and Hypovitaminosis D individually as well as in association.

 
Close