A clinical study to evaluate the effect of a test product (Lactic acid based Probiotic tablet) for Treatment of Iron Deficiency Anemia in participants with Menorrhagia and Premenstrual Syndrome.

Not yet recruiting

• Conditions: Iron deficiency anemia, unspecified,

• Registration Number: CTRI/2025/04/085257
• Lead Sponsor: CLAPS Industries Pvt. Ltd.

Brief Summary

This is a Multi-centre, Randomized,Double-blind, Two-arm, Comparative, Placebo-controlled Study to Evaluate theEfficacy and Safety of Lactic acid based Probiotic tablet for Treatment of IronDeficiency Anemia in participants with Menorrhagia and Premenstrual Syndrome.

The potential Participants will bescreened as per the inclusion and exclusion criteria only after obtainingwritten informed consent from the Participants.

All eligible Participants willundergo laboratory evaluation *(blood tests)* and evaluation usingdifferent scales/questionnaires. Safety will be assessed throughout the studyby monitoring vital signs and adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• 1.Age: a.Adolescent female participants who have reached Menarche.
• OR b.Pre-menopausal female participants.
• 2.Participants with diagnosis of Iron Deficiency Anemia (IDA) as confirmed by low Hb levels and low serum ferritin levels as per PI’s discretion.
• 3.Participants with Menorrhagia.
• OR Participants with Premenstrual syndrome 4.Participants having good general health as determined by the Investigator on the basis of medical history and physical examination.
• 5.Participants willing to consume test product throughout the study period as instructed.
• 6.Participants should be willing and able to follow the study protocol to participate in the study.

Exclusion Criteria

• 1.Pregnant or breastfeeding or planning pregnancy during the study period.
• 2.Participants with severe anemia, defined as hemoglobin levels less than 8 g/dL.
• 3.Participants with history of acute peptic ulcer, severe GERD and/or ulcer complications or other functional GI disorder.
• 4.Participants with clinically suspected uterine leiomyomas, adenomyosis, or polyps.
• 5.Participants with clinically suspected malignancy of the uterus or cervix.
• 6.Participants with history of pregnancy-related conditions such as miscarriages, abortions, intrauterine growth restriction (IUGR), etc.
• 7.Participants having any chronic illness or health condition such as hyperthyroidism or hypothyroidism, diabetes, Peripheral Artery Disease, CKD, previous major surgery, HIV, hepatitis etc.
• that can interfere with the outcome of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of CBC and serum ferritin levels	Screening Visit (i.e., within 07 days of enrollment) to Day 60 (+ 02 Days), Day 90 (+ 02 Days) and Day 105 (+ 02 Days)

Secondary Outcome Measures

Name	Time	Method
Assessment of Menorrhagia Symptoms	Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days)
Assessment of Overall Quality of Life	Day 00 (i.e., baseline) and Day 105 (plus 02 Days)
Assessment of Serum Iron Levels, Total Iron-Binding Capacity (TIBC) and Transferrin Saturation	Screening Visit (i.e., within 07 days of enrollment) and Day 105 (plus 02 Days)
Assessment of Menstrual cramp pain	Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days)
Assessment of Fatigue Levels	Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days)
Assessment of Mood Swings	Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days)

Trial Locations

Locations (3)

Atharva multispecialty hospital & Research Centre (Site 01); 🇮🇳 Lucknow, UTTAR PRADESH, India

Navneet Memorial Hospital "Sushrusha” (Site 03); 🇮🇳 Ahmadabad, GUJARAT, India

Tender Palm Hospital (Site 02); 🇮🇳 Lucknow, UTTAR PRADESH, India

Atharva multispecialty hospital & Research Centre (Site 01)

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Neetu Verma

Principal investigator

8535024005

Hospital.atharva@gmail.com