Management of Iron Deficiency Anemia through Ayurveda
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2023/08/056926
- Lead Sponsor
- Central Council of Research in Ayurvedic Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects of any gender aged 18-60 years and diagnosed with IDA
2.Mean corpuscular volume (MCV) below 80 fl.
3.Hemoglobin 8-10.9 gm/dl (as per WHO)
4.Willing to provide written informed consent
1.Iron deficiency due to blood loss from the intestine or other sites.
2.Other causes of anemia, apart from iron deficiency, apparent by history, physical examination, and/or laboratory tests.
3.Iron deficiency anemia necessitating parenteral iron therapy
4.Intake of Iron supplements for three months before the initiation of the study.
5.Participants with Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit)
6.Participants with Renal Dysfunction (defined as S. creatinine >1.2 mg/dl);
7.History of uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular disease, psychiatric illness, tuberculosis, HIV, malignancy, etc.
8.Patients suffering from major systemic illnesses necessitating long-term treatment (Psycho-neuro-endocrinal disorders, etc.)
9.Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that affect erythropoiesis, less than three months before the start of the study.
10.Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study.
11.History or active substance abuse
12.History of hypersensitivity to the trial interventions or their ingredients.
13.Any other condition that in the opinion of the investigator may compromise the participant’s safety or compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Assessment of the tolerability of the Ayurvedic intervention through reported incidence of treatment-emergent adverse events & serious adverse events during the study period [ Time Frame: [Baseline to day 90] <br/ ><br>2.Assessment of treatment adherence through self-reported compliance log & used medication containers/strips. [Time frame: Baseline, 30th day, 60th day, 90th day]Timepoint: Baseline, 30th day, 60th day, 90th day
- Secondary Outcome Measures
Name Time Method