| CTRI Number |
CTRI/2021/07/034881 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The impact of Multigrain Instant Health Drink Mix in anemia. |
|
Scientific Title of Study
|
A randomized controlled clinical trial to study the impact of Multigrain Instant Health Drink Mix in clinical management of anemia in women. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/21-22/010, Version 1.0. dated, 10th June 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VG Vaidya |
| Designation |
Managing Trustee |
| Affiliation |
Lokmanya Medical Research Centre |
| Address |
Forth floor, OPD 401, 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India
Pune
MAHARASHTRA
411033
India |
| Phone |
9822057766 |
| Fax |
|
| Email |
vgvaidya178@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vetriselvi R |
| Designation |
Assistant Manager R and D |
| Affiliation |
Southern Health Foods Pvt Ltd |
| Address |
No 480 Khivraj Complex 1 3 floor Anna Salai Nandanam Chennai 600035
Chennai
TAMIL NADU
600035
India |
| Phone |
04443504417 |
| Fax |
|
| Email |
vetriselvi.r@mannafoods.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Murugan Narayanaswamy |
| Designation |
Chief Executive Officer |
| Affiliation |
Southern Health Foods Pvt Ltd |
| Address |
No 480 Khivraj Complex 1 3 floor Anna Salai Nandanam Chennai 600035
Chennai
TAMIL NADU
600035
India |
| Phone |
04443504417 |
| Fax |
|
| Email |
murugan.n@mannafoods.in |
|
|
Source of Monetary or Material Support
|
| Southern Health Foods Pvt Ltd (Manna)
No.480, Khivraj Complex 1, 3rd floor, Anna
Salai, Nandanam, Chennai – 600035.
|
|
|
Primary Sponsor
|
| Name |
Southern Health Foods Pvt Ltd |
| Address |
No.480, Khivraj Complex 1, 3rd floor, Anna
Salai, Nandanam, Chennai – 600035. |
| Type of Sponsor |
Other [Nutraceutical manufacturing and promotion] |
|
|
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 V G Vaidya |
Lokmanya Medical Research Centre and Hospital |
Forth floor, LHCC building, 401 OPD, 314/B Telco
Road, Chinchwad Pune
Pune MAHARASHTRA
411033 India
Pune
MAHARASHTRA |
9822057766
vgvaidya178@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
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 |
| Comparator Agent |
Milk |
Only milk twice a day with anemia education and counselling for 90 days |
| Intervention |
Multigrain instant health drink mix for Women |
2 servings per day with warm milk. Each serve size – 30g for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Female of age group between 18-45 (Both inclusive).
2.Those willing to give written informed consent and willing to adhere to protocol requirements.
3.Subjects with anemia with or without folate/ vitamin B12 deficiency having hemoglobin concentration less than 12 g/dL but more than 8 g/dL.
4.Subjects with or without symptoms of anemia.
|
|
| ExclusionCriteria |
| Details |
1.Getting any iron supplements for treating anemia.
2.Consuming any complementary medicine, dietary supplements containing iron, vitamins, antioxidants etc.
3.Participated in clinical trial for anemia in last 3 months span of screening.
4.Pregnant and breastfeeding women.
5.Known history of hypersensitivity for the investigational product ingredients.
6.Subjects with or without PCOD, diabetes, hypertension, thyroid disorder or other fertility disorders which from investigator viewpoint prove subject unfit to be enrolled in the study.
7.Subjects on hormone replacement therapy and/or taking contraceptive pills for birth control
8.Medical history of malabsorption syndrome, hemochromatosis.
9.Obvious internal or external bleeding as documented by medical history or any surgeries undergone within past 4 weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hemoglobin, Ferritin, Iron, total Iron binding protein level
Fatigue severity score, Changes in Hematocrit, MCV, MCH and MCHC, Clinical signs and symptoms like weakness, pale or yellowish skin, irregular heartbeats, dysmenorrhea, ,dizziness or lightheadedness, cold hands and feet, Quality of life score with bone strength and stamina, Energy audit questionnaire, Complexion evaluation by CLBT scale, Safety of intervention |
Screening and day 90. Hemoglobin levels on Screening, day 30, 60 and 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/07/2021 |
| Date of Study Completion (India) |
18/12/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Anemia is prevalent and is a cause affecting the quality of life of every second woman in developing countries. Southern Health Foods Pvt Ltd has come up with Multigrain Instant Health Drink Mix (Istrong) which is developed with Iron lock method which is 100% RDA of Iron, Vitamin C, Vitamin B9 & B12 in 2 serves of the product. It is specially designed for women to benefit at improving stamina, bone health, skin complexion, and metabolism. Present research is the clinical trial designed to validate the effectiveness of Multigrain Instant Health Drink Mix (Istrong) in anemia especially in women.
It can be concluded from the present study that Multigrain Instant Health Drink Mix (Istrong) is safe and efficacious in treatment of anemia in women. It can offer 360 degree improvement in anemia. It ensures improvement in Hb, Ferritin, Iron levels along with reduction in TIBC. Treatment with Multigrain Instant Health Drink Mix (Istrong) ascertained the fact that it can provide a wholesome improvement in quality of life, symptoms alleviation and improved skin tone and luminosity. These results can provide a firsthand evidence to the fact that there are no adverse events related to study intervention alike the oral iron supplementation in the treatment of anemia. It indicates that the iron and other micro-nutrition delivered through the Multigrain Instant Health Drink Mix (Istrong) is more assimilated and provided the sustainable results for anemia. The present research ensures consumers of this product to get the effectiveness to treat and manage the anemia and related complaints with no side effects related to iron supplementation. |