The impact of Multigrain Instant Health Drink Mix in anemia.

A randomized controlled clinical trial to study the impact of Multigrain Instant Health Drink Mix in clinical management of anemia in women. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034881

Enrollment

Registered

2021-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Multigrain instant health drink mix for Women: 2 servings per day with warm milk. Each serve size Ã¢â?¬â?? 30g for 90 days Control Intervention1: Milk: Only milk twice a day with anemia

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 interventionTimepoint: Screening and day 90. Hemoglobin levels on Screening, day 30, 60 and 90.	—

Measure

Time frame

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 interventionTimepoint: Screening and day 90. Hemoglobin levels on Screening, day 30, 60 and 90.

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactMr Murugan Narayanaswamy

Southern Health Foods Pvt Ltd

vetriselvi.r@mannafoods.in04443504417

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026