Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: LipokonTM Iron: One tablet twice daily Orally, swallowed with week for 8 weeks.
Control Intervention1: Standard Iron pyrophosphate: One tablet twice daily Orally,swallowed with week for
Sponsors
Konark Herbals & HealthCare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female Participants aged 18 to 40 years at the time of screening. 2. Confirmed diagnosis of iron deficiency anemia (IDA), defined as: a. Hemoglobin (Hb) level in the range of 8 to 11.9 g/dL b. Serum ferritin less than 30 ng/mL c. Transferrin saturation below 20 percent 3. Participants must agree to use effective contraception during the study period, if applicable. 4. Participants must be willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known history of any chronic uncontrolled systemic illnes. 2.Known hypersensitivity or intolerance to iron, folic acid, methylcobalamin, zinc, or any component of the study medication. 3.Anemia due to non-iron deficiency causes, such as: a) Hemolytic anemia b) Aplastic anemia c) Megaloblastic anemia unrelated to iron deficiency d) Thalassemia or other hemoglobinopathies 4.Known history of chronic inflammatory conditions (e.g., rheumatoid arthritis, IBD) that may affect iron metabolism. 5.History of malabsorption syndromes (e.g., celiac disease, bariatric surgery) unless well-controlled. 6.Use of parenteral/oral iron therapy or blood transfusion in the past 12weeks. 7.Current use of other iron supplements or multivitamins containing iron. 8.Any condition that, in the investigator s judgment, may compromise safety, compliance, or study integrity. 9.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 10.Pregnant or lactating women, or women planning pregnancy during the study period. 11.Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin (Hb) levels from baseline to the end of treatment(8 week).Timepoint: 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in serum ferritin levels. 2. Mean change in serum iron & transferrin saturation (TSAT) 3. Change in fatigue symptoms as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. 4. Percentage of participants achieving target Hb levels (Less than or equal to12 g/dL) by end of treatment. Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed