| CTRI Number |
CTRI/2024/04/066244 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of amla in honey in the correction of anemia in pregnancy |
|
Scientific Title of Study
|
Effect of supplementation of Amla (Emblica officinalis) in Honey on the hematological profile and iron homeostasis in anemic pregnancy: An open -labelled clinical 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 |
SanthossiniS |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of biochemistry
JIPMER Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488910249 |
| Fax |
|
| Email |
santhossini1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zachariah Bobby |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of biochemistry, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443602996 |
| Fax |
|
| Email |
zacbobby@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SanthossiniS |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of biochemistry
JIPMER Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488910249 |
| Fax |
|
| Email |
santhossini1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantari nagar puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Santhossini S |
JIPMER |
Department of Obstetrics and Gynecology
Dhanvantari nagar puducherry 605006
Pondicherry
PONDICHERRY |
9488910249
santhossini1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amla(Emblica officinalis) soaked in honey |
The intervention group will be provided supplementation of two amla (Emblica officinalis) FSSAI certified, soaked 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 regularly advised by their treating doctors |
| Comparator Agent |
nil |
comparator group will be supplemented with usual oral iron therapy (60mg elemental iron three times a day) along with life style modifications which is regularly advised by their treating doctors |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hemoglobin level
Hematological profile
Indices of iron homeostasis |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
45 days |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 1 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="2"
Months="0"
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
|
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 |