| CTRI Number |
CTRI/2026/03/105399 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exploring the effects of neem leaves on individuals with iron deficiency anemia |
|
Scientific Title of Study
|
Evaluation of the effect of neem leaves(Azadirachta indica) in patients with iron deficiency anemia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushree R Havale |
| Designation |
UG Student |
| Affiliation |
Navodaya Medical College Hospital and Research center |
| Address |
Navodaya Medical College, Hospital and Research Center, Raichur, Karnataka 584103
Raichur
KARNATAKA
584103
India |
| Phone |
6360079823 |
| Fax |
|
| Email |
ansuhreehavale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand A S |
| Designation |
Prof and Head, Dept of Pathology, Navodaya Medical College Hospital and Research Center |
| Affiliation |
Navodaya Medical College Hospital and Research center |
| Address |
Navodaya Medical College
Hospital and Research Center
Mantralayam Road
Raichur5 84103
Raichur
KARNATAKA
584103
India |
| Phone |
9880765836 |
| Fax |
|
| Email |
asanand27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra Havale |
| Designation |
Prof and Head, Dept of Pedodontics, AMES Dental College, Raichur |
| Affiliation |
AMES Dental College and Hospital , Raichur |
| Address |
AMES Dental College and Hospital
Bijengera Road
Raichur 584103
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Navodaya Medical College , Hospital and Research Center,
Mantralayam Road,
Raichur,Karnataka , India - 584103 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
Advance Research Department,
Rajiv Gandhi University of Health Sciences,
4th T block, Jayanagar, Banglore-560041,Karnatake,India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Anushree R Havale |
Navodaya Medical College, Hospital and Research Center |
Department of Pathology,
Room no:38,
2nd floor,
Hospital building
Raichur
KARNATAKA |
6360079823
ansuhreehavale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (IHEC), Navodaya Medical College |
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 |
Neem Leaf Therapy (Azadirachta indica) for patients with Iron Deficiency Anaemia |
Each participant in the intervention group will be provided with fifteen fresh neem leaves. Participants will be instructed to chew and consume one fresh neem leaf daily on an empty stomach in the morning. The intervention will be continued for a total duration of 15 consecutive days. |
| Comparator Agent |
Oral ferrous Sulphate supplementation for patients with Iron Deficiency Anaemia |
Participants in the comparator group will receive oral Ferrous sulphate supplementation, once daily for a total duration of 15 consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)The subjects suspected with iron deficiency anaemia with less than 10 gm% of hemoglobin concentration.
2)The subjects who are in the age group of 18-45 years
|
|
| ExclusionCriteria |
| Details |
1)Patients who have taken iron supplements within the last six months will be excluded from the study.
2)Patients with comorbid conditions or any other hematological abnormalities will also be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of neem leaves in increasing haemoglobin concentration (Hb%), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), and mean corpuscular haemoglobin concentration (MCHC) in patients with iron deficiency anaemia. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
20/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 anaemia is one of the most common nutritional disorders in India, affecting a significant proportion of adults, especially women. Although oral iron supplementation is the standard treatment, it is commonly associated with gastrointestinal side effects leading to poor compliance. Neem (Azadirachta indica) leaves have demonstrated hematinic potential in animal and in-vitro studies. This interventional study aims to evaluate the effect of daily consumption of fresh neem leaves on haemoglobin levels and other haematological parameters in patients with iron deficiency anaemia. Thirty participants aged 18–45 years with haemoglobin less than 10 g/dL will be enrolled and divided into two groups. The study group will receive one fresh neem leaf daily on an empty stomach for 15 days, while the comparator group will receive oral ferrous sulphate supplementation for the same duration. Haematological parameters including haemoglobin percentage, RBC count, hematocrit, MCV, MCH, MCHC, RDW, and peripheral smear findings will be assessed before and after the intervention. The study intends to determine whether neem leaves can serve as a potential alternative or adjunct therapy in the management of iron deficiency anaemia. |