| CTRI Number |
CTRI/2025/08/092420 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of natural iron-rich food supplementation and Health Education on Anaemia in Rural Women |
|
Scientific Title of Study
|
Anaemia redressal through Natural diet and Education - A prospective longitudinal
trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivethitha L |
| Designation |
Professor |
| Affiliation |
National Institute of Naturopathy. Pune |
| Address |
National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048
Pune
MAHARASHTRA
411048
India |
| Phone |
08496930190 |
| Fax |
|
| Email |
dr.nivethitha@gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Naresh |
| Designation |
Research officer |
| Affiliation |
National Institute of Naturopathy. Pune |
| Address |
# 2, Department of Research and development, Admin block, National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048
Pune
MAHARASHTRA
411048
India |
| Phone |
9976157398 |
| Fax |
|
| Email |
dr.nareshro@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Naresh |
| Designation |
Research officer |
| Affiliation |
National Institute of Naturopathy. Pune |
| Address |
# 2, Department of Research and development, Admin block, National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048
Pune
MAHARASHTRA
411048
India |
| Phone |
9976157398 |
| Fax |
|
| Email |
dr.nareshro@gov.in |
|
|
Source of Monetary or Material Support
|
| National institute of naturopathy, Nisarg gram, pune-4 |
|
|
Primary Sponsor
|
| Name |
National institute of Naturopathy |
| Address |
National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048 |
| Type of Sponsor |
Other [Autonomous body] |
|
|
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 |
| Nivethitha L |
National institute of Naturopathy |
#2, Admin block, department of womens health, National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048
Pune
MAHARASHTRA |
08496930190
dr.nivethitha@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NIN, Pune |
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 |
Natural Dietary Supplements and health education |
Daily intake of locally prepared iron-rich foods using Moringa, curry leaves, and Hibiscus sabdariffa, and 2 hours of health education |
| Comparator Agent |
regular diet |
regular diet |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Women of reproductive age 15–49 years
2.Haemoglobin levels less than 12.0 g/dL
3. resident of the target study community for at least 6 months and willing to remain in the area during the intervention period.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with severe or life-threatening anaemia requiring immediate medical intervention
2. Individuals currently on iron supplementation or multivitamin therapy in the last 4 weeks
3. Pregnant women
4. Individuals diagnosed with hemoglobinopathies such as thalassemia or sickle cell anemia
• Known hypersensitivity or dietary restrictions related to the food items being studied (Moringa, curry leaf, Hibiscus)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemoglobin levels |
Baseline (Day 0 – Pre-intervention
2. End of Intervention (1 Month)
3. Follow-Up 1 (3 Months Post-Baseline): All assessment
4. Follow-Up 2 (6 Months Post-Baseline)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life (QoL)
Menstrual Pain Intensity
Subjective Vitality
Mental Well-Being
Anthropometric |
Baseline (Day 0 – Pre-intervention
2. End of Intervention (1 Month)
3. Follow-Up 1 (3 Months Post-Baseline): All assessment
4. Follow-Up 2 (6 Months Post-Baseline) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Anaemia remains a significant global and national public health concern, particularly affecting young children, adolescent girls, and women of reproductive age. In India, anaemia affects over half of all women in this group, primarily due to iron deficiency and poor dietary practices. Conventional iron supplementation often causes side effects and poor adherence. Natural, iron-rich foods like Moringa oleifera, curry leaves, and Hibiscus sabdariffa offer promising, bioavailable, and culturally acceptable alternatives. Combining these dietary interventions with structured health education may enhance adherence and provide sustainable improvements in anaemia and overall health. Objectives: To assess the short-term and long term impact of natural dietary supplements on haemoglobin levels and quality of life in women with anaemia. Design: Prospective longitudinal trial, Setting: Community-based recruitment from local centres Sample Size: 100 women of reproductive age (15–49 years) with haemoglobin <12.0 g/dL Duration:1-month intervention, with follow-ups at 3 and 6 months Assessments: Conducted at baseline, end of intervention, and two follow-up points. Measures include: Biochemical markers (haemoglobin, CBC), Anthropometric measurements, Quality of life (SF-36), Menstrual pain (VAS), Vitality (Subjective Vitality Scale), Mental well-being (WEMWBS) |