Health Condition 1: D509- Iron deficiency anemia, unspecified Health Condition 2: D539- Nutritional anemia, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 60 to 75 years of any gender will be included. Haemoglobin will be measured using venous blood through a laboratory haematology analyser, with inclusion ranges defined as 8 to 11.9 g per dL for women and 8 to 12.9 g per dL for men. Participants should be ambulatory and medically stable, with or without medication, and must have a score of at least 4 on the Katz Index of Independence in Activities of Daily Living and at least 3 on the Mini Cog scale. Participants must be able to provide written informed consent and comply with study procedures, including adherence counselling and monthly follow up visits.
Exclusion criteria
Exclusion criteria: Participants will be excluded if haemoglobin is 12 g per dL or higher or less than 8 g per dL in women, and 13 g per dL or higher or less than 8 g per dL in men, or if anaemia requires immediate blood transfusion, parenteral iron therapy, or any other urgent medical intervention. Participants presenting with any clinical condition, including acute infections, that requires urgent medical or surgical intervention will be excluded. Known cases of anaemia due to secondary or non nutritional causes, including active gastrointestinal bleeding or recent major blood loss, haemolytic or aplastic anaemia, thalassemia, or other haemoglobinopathies will be excluded. Known cases of chronic inflammatory or autoimmune diseases that may affect haematological parameters or require medical intervention will be excluded. Known cases of cancer under treatment, or receipt of systemic chemotherapy, immunotherapy, or radiotherapy within the preceding 12 months will be excluded. Participants who have received blood transfusion, intravenous iron, or erythropoiesis stimulating agents such as Epoetin Alfa Renocel, Zyrop, Epofit, Eposis, Repoitin, Vintor, Wepox, Eporise, Relipoietin, or Eprex within 12 weeks prior to screening will be excluded. Patients on oral iron supplements for the last 6 weeks will be excluded. Presence of clinically significant gastrointestinal disorders likely to impair digestion or absorption of the study medication, such as malabsorption syndromes, inflammatory bowel disease, celiac disease, or major gastrointestinal surgery, will lead to exclusion. Patients on treatment for any psychiatric illness, epilepsy, hypersensitivity or allergy, acid peptic disorder, Parkinson disease, severe neurological deficit, cognitive impairment, or severe frailty will be excluded. History of or active substance abuse with a CAGE score more than 2 will be excluded. Participants with hepatic dysfunction defined as AST and or ALT more than 2 times the upper normal limit, or with renal dysfunction defined as serum creatinine more than 1.2 mg per dL will be excluded. Participants with poorly controlled comorbid conditions, including HbA1c more than 9 percent, thyroid stimulating hormone more than 10 mU per L, or uncontrolled hypertension defined as systolic blood pressure more than 150 mm Hg or diastolic blood pressure more than 90 mm Hg despite ongoing treatment will be excluded. History of allergy or intolerance to any component of the study intervention or to similar Ayurvedic formulations will be excluded. Any other condition that, in the opinion of the investigator, may compromise the participant s safety, outcome, or treatment adherence will also lead to exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who become non-anaemic (haemoglobin concentration in venous blood at least 13 g/dL in men and at least 12 g/dL in women) after treatment. Venous blood samples will be collected and measured using a validated laboratory haematology analyser at an accredited lab.Timepoint: Baseline, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in haemoglobin measured in grams per decilitre will be assessed using venous blood samples.Timepoint: Baseline, 90;Time taken to achieve haemoglobin levels (using a reflectance photometry-based digital hemoglobinometer) in the optimal rangeTimepoint: Baseline, 30, 60, 90;Change in erythrocyte-related parameters in CBC and peripheral smearTimepoint: Baseline, 90;Change in the levels of Serum Ferritin, Transferrin saturationTimepoint: Baseline, 90;Change in the high sensitivity C-Reactive ProteinTimepoint: Baseline, 90;Change in safety outcomes viz., liver function test, kidney function test, including eGFR and Urine Albumin-Creatinine RatioTimepoint: Baseline, 90;Change in health-related quality of life assessed using the EQ-5D-5L instrument, measured as the difference in EQ-5D-5L index and EQ-VAS scores from baseline to 30, 60, and 90 daysTimepoint: Baseline, 90;Change in the score of FACIT-Fatigue scaleTimepoint: Baseline, 90;Change in anaemia-related symptoms, including loss of appetite, breathlessness on exertion, dizziness, palpitations, generalised weakness, and pallorTimepoint: Baseline, 30, 60, and 90 days;Change in score of the Timed Up and Go Test (TUGT)Timepoint: Baseline, 90;Proportion of participants reporting the intervention as acceptable (e.g., rating at least 4 on a 5-point Likert acceptability item); thematic summary from qualitative interviews.Timepoint: Day 90;Proportion of participants reporting greater than or equal to 80 percent of treatment adherenceTimepoint: ;Mean scores of the Effectiveness, Side-effects and Convenience related domains of the Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) domain scores and Global Satisfaction score.Timepoint: Day 90 | — |
Countries
India
Contacts
Public ContactDr Renu Rani
Central Ayurveda Research Institute
Outcome results
None listed