Impact of traditional ayurvedic preparation vs yoga vs placebo on Iron Deficiency Anemia.

Recruiting

• Conditions: Iron deficiency anemia. Ayurveda Condition: PANDUROGAH,

• Registration Number: CTRI/2021/11/038224
• Lead Sponsor: Patanjali Research Institute governed by Patanjali Research Foundation Trust

Brief Summary

This study is a three-arm, open-label, parallel-group and placebo-controlled trial. The trial will randomize 123 participants in the ratio of 1:1:1 of 18 yrs. and above equally to 1st arm: Ayurvedic intervention, 2nd arm: Yogic practices, 3rd arm: Placebo. Participants will receive interventions for 3 months.

The primary outcome includes improvement in laboratory parameters after 3 months of interventions. Secondary outcomes include assessment of treatment satisfaction, patient’s compliance, sleep quality, quality of life, mood states, pain and anxiety levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Adult male and non-pregnant female population having mild or moderate Iron Deficiency anemia (IDA) caused by different aetiology such as abnormal uterine bleeding and other conditions leading to significant blood loss prior to trial enrolment.
• Hemoglobin ranges Non pregnant women mild: 110 to 119 g per l, moderate: 80 to 109 g per l.
• Men, 15 years and above mild: 110 to 129 g per l, moderate: 80 to 109g per l.
• Transferrin saturation less than 20% 4.
• S-ferritin less than 30 µg per l.
• Willingness to participate and sign the informed consent form.

Exclusion Criteria

• 1.Anemia predominantly caused by factors other than Iron Deficiency Anemia e.g. anemia with untreated vitamin B12 or folate deficiency, sickle cell anemia, thalassemia minor.
• Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
• Pregnant or lactating women.
• Known hypersensitivity to any excipients in the investigational drug products.
• Erythropoietin treatment within 8 weeks prior to the screening visit.
• Patients planning surgery within the trial phase or received a blood transfusion a week prior to the screening visit.
• Any other medical condition that, in the opinion of investigator, make the patient incompetent to participate in the trial or place the patient at potential risk, e.g. any chronic comorbidity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in laboratory parameters compared to baseline after 3 months of Ayurvedic intervention.	Baseline, Day 90
Change in laboratory parameter compared to baseline after 3 months of yogic practices.	Baseline, Day 90

Secondary Outcome Measures

Name	Time	Method
Changes in sleep quality, quality of life, anxiety levels, fatigue, mood states and pain.	Treatment satisfaction and adherence.

Trial Locations

Locations (1)

Patanjali Yog Gram; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Yog Gram

🇮🇳Hardwar, UTTARANCHAL, India

Dr Anurag Varshney

Principal investigator

7302254792

clinical.investigator@prft.in