Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Test product i.e. Tablet: Two tablets (one tablet in the morning and one tablet in the evening) will be consumed with water after meals till the end of the study
Control Intervention1:
Sponsors
CLAPS Industries Pvt. Ltd.
Eligibility
Inclusion criteria
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
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. 8. Participants suffering from diseases Alzheimer s, Parkinson s disease, and dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of CBC and serum ferritin levelsTimepoint: Screening Visit (i.e., within 07 days of enrollment) to Day 60 (+ 02 Days), Day 90 (+ 02 Days) and Day 105 (+ 02 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Menorrhagia SymptomsTimepoint: Day 00 (i.e., baseline) to Day 60 (plus 02 Days), Day 90 (plus 02 Days) and Day 105 (plus 02 Days);Assessment of Menstrual cramp painTimepoint: 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 LevelsTimepoint: 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 SwingsTimepoint: 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 LifeTimepoint: Day 00 (i.e., baseline) and Day 105 (plus 02 Days);Assessment of Serum Iron Levels, Total Iron-Binding Capacity (TIBC) and Transferrin SaturationTimepoint: Screening Visit (i.e., within 07 days of enrollment) and Day 105 (plus 02 Days) | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed