Effect of supplementation of Amla (Emblica officinalis) in Honey on the hematological profile and iron homeostasis in anemic pregnancy: An open -labelled clinical trial.
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- JIPMER
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Hemoglobin level
Overview
Brief Summary
RESEARCH QUESTION
Does supplementation of Amla (Emblica officianalis) in anemic pregnant women improve their hematological profile and iron homeostasis
AIM
To assess the effect of supplementation of Amla (Emblica officianalis) in honey in anemic pregnant women on their hematological profile and indices of iron homeostasis
OBJECTIVES
PRIMARY
(1) Estimations of the hematological profile and indices of iron homeostasis before and after supplementation of Amla (Emblica officianalis) in a group of anemic pregnant women for a period of 45 days in addition to their regular iron supplementation.
(2) Estimations of the hematological profile and indices of iron homeostasis before and after 45 days of regular oral iron supplementation in another group of anemic pregnant women.
(3) Comparison of the changes in the hematological profile and iron homeostasis between the two groups after the 45 days of study
SECONDARY
(1) Assessment of the quality of life in anemic pregnant women in general and in relation to gastro intestinal disturbances, nausea and vomiting using standard questionnaires with and without Amla supplementation.
(2) Correlation analyses among indices of iron homeostasis, oxidative stress and inflammation.
METHODOLOGY
After the successful registration in CTRI Pregnant women with mild iron deficiency anemia on oral iron therapy visiting the Obstetrics and Gynecology department antenatal out patient clinic meeting the inclusion and exclusion criteria will be recruited as the participants of the study
They will be divided into two groups by block randomization with stratification by convenient sampling method
Control group will be supplemented with usual oral iron therapy (60mg elemental iron three times a day) along with life style modifications which is advised by their treating doctor
Interventional group will be provided supplementation of two amla in honey (one in the morning and one in the night) every day for 45 days along with usual oral iron therapy (60mg elemental iron three times a day) and life style modifications which is advised by their treating doctor
The investigations including serum hepcidin, oxidative stress, serum ferritin and soluble transferrin receptor and hsCRP levels and hematological profile will be assayed before and after intervention along with their quality of life
The data will be statistically analysed
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Hemoglobin level between 9 to 11 milligram per deciliter Age between 18 to 35 years 1st and 2nd trimester of pregnancy On oral iron therapy.
Exclusion Criteria
- •Patients with a history of anemia due to any other conditions like bleeding piles cardiac or renal or liver disorders Diabetes Mellitus Hypertension Pregnancy induced complications like hyperemesis gravidarum antepartum hemorrhage pre eclampsia eclampsia GDM jaundice Patients with a history of drug abuse Patients with a history of allergy to amla or honey.
Outcomes
Primary Outcomes
Hemoglobin level
Time Frame: 45 days
Hematological profile
Time Frame: 45 days
Indices of iron homeostasis
Time Frame: 45 days
Secondary Outcomes
- Quality of life(45 days)
Investigators
SanthossiniS
JIPMER