| CTRI Number |
CTRI/2023/02/050038 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of the Homoeopathic Medicine Moringa oleifera in treatment of Iron deficiency anemia |
|
Scientific Title of Study
|
An open labeled prospective clinical case series study to assess the effectiveness of Moringa oleifera 6CH in treating iron deficiency anemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
C Aiswarya Lakshmi |
| Designation |
Compulsory Rotatory Residential Internship |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No 3d, Medical Unit IV, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road, Seeragapadi PO
Salem
TAMIL NADU
636308
India |
| Phone |
9486235326 |
| Fax |
|
| Email |
aisuchandru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Janani |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No 3d, Medical Unit IV, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road, Seeragapadi PO
Salem
TAMIL NADU
636308
India |
| Phone |
8667601906 |
| Fax |
|
| Email |
janudr.homoeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Janani |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No 3d, Medical Unit IV, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road, Seeragapadi PO
Salem
TAMIL NADU
636308
India |
| Phone |
8667601906 |
| Fax |
|
| Email |
janudr.homoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road, Seeragapadi PO, Salem, Tamilnadu-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH47, Sankari Main Road, Seeragapadi PO, Salem, Tamilnadu |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Homoeopathy |
61-65, Institutional Area, Opp D Block, Janak Puri, New Delhi 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Janani |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No:3 D- Department of Practice of Medicine OPD Unit, Ground Floor, Hospital Block, VMHMCH, NH47, Sankari Main Road, Seeragapadi PO, Salem
Salem
TAMIL NADU |
8667601906
janudr.homoeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Intervention |
Moringa oleifera 6CH |
4 medicated globules of 30 size will be prescribed orally every morning for minimum 60 days before food. Follow up will be done fortnightly. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Mild cases of iron deficiency anemia i.e Haemoglobin level of 10gms/dL- 11gms/dL are included |
|
| ExclusionCriteria |
| Details |
Individuals suffering from other systemic diseases,
Pregnant and Lactating women,
Moderate (Haemoglobin level of 7gms/dL- 9.9gms/dL) and Severe cases (Haemoglobin level below 7gms/dL) of iron deficiency anemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive modulation of Haemoglobin Concentration |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue severity scale questionnaire |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anemia is defined as qualitative or quantitative deficiency of Haemoglobin in RBCs. According to WHO it is defined as Haemoglobin levels less than 12.0 gms/dL in women and less than 13.0 gms/dL in men and Haemoglobin level of 10gms/dL -11 gms/dL is early anemia, Level below 10gms/dL is marked anemia, Level below 7gms/dL is severe anemia. According to NFHS 2019-20, more than half of Indian children and women are anemic.Iron deficiency anemia maybe caused due to insuffient dietary intake and absorption of irin or iron loss due to severe bleeding. Homoeopathic medicines like Ferrum phosphoricum 3X, Ferrum metallicum 6X, Carica papaya 30 area found to be effective in treating iron deficiency anemia. Serum Ferritin and Haemoglobin Concentration are some of the lab investigations done for iron deficiency anemia. Moringa oleifera (Common name : Drumstick) is an edible species which is a widely cultivated species of the family Moringaceae. Moringa oleifera 100gms/ day with jaggerybas a native treatment was found to be effective by showing improvement in haemoglobin levels in women of reproductive age group. The use of Moringa leaf powder has reduced the prevalence of anemia cases by half and brought about improvement in moderate anemia cases. Moringa leaves extract as well as powder had found to be effective in rats induced with anemia. It showed highest PCV, HB and RBC. In extensive literature search , as there are no any previous studies in treating anemia with Homoeopathic medicine Moringa oleifera, Iam intended to do a clinical case series study to assess the effectiveness of Moringa oleifera 6CH in treating Iron deficiency anemia(ICD10:D50.9) which may be helpful in clinical practice in future. |