The impact of Multigrain Instant Health Drink Mix in anemia.

Phase 2

Completed

Conditions: Iron deficiency anemia, unspecified,

Registration Number: CTRI/2021/07/034881

Lead Sponsor: Southern Health Foods Pvt Ltd

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin, Ferritin, Iron, total Iron binding protein level	Screening and day 90. Hemoglobin levels on Screening, day 30, 60 and 90.
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 Measures

Name	Time	Method

Trial Locations

Locations (1): Lokmanya Medical Research Centre and Hospital
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Research Centre and Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr V G Vaidya
Principal investigator
9822057766
vgvaidya178@gmail.com