A Clinical Study to Assess the Effectiveness of Loha Gudhadi Gutika on Hemoglobin in Iron Deficiency Anemia in Adolescent Girls.

Phase 2

Not yet recruiting

• Conditions: Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH,

• Registration Number: CTRI/2025/06/088446
• Lead Sponsor: Dr Sonia Madhukar Sawant

Brief Summary

This clinical study is prospective, open label, randomized , active control , parallel group study to evaluate the effect of Loha Gudhadi Gutika at the dose of 250 mg BID daily with Udashwit  After meals for 90 days on hemoglobin gm percent in Adolescent girls age group 10 years to 16 years with clinical signs of iron deficiency anemia and classical sign and symptoms of Panduroga at Kaumarbhritya Department of Ayurved Institute and Hospital , Maharashtra , India . The Primary outcome measures hemoglobin gm percent on 90 days . The secondary outcome will be to determine the tolerance and safety of Loha Gudhadi Gutika in iron deficiency anemia in adolescent girls and compare the effectiveness of Loha Gudhadi Gutika and Tablet ferrous sulfate at the dose of 60mgFe OD daily , two hours after meals with water for 90 days in Iron deficiency anemia ( Panduroga).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-06
• Study Start: 2025-06-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

1)Patients with clinical Features of iron deficiency anemia only 2)Patients with Classical sign and symptoms of Panduroga described in Ayurveda texts Vivarnata ( Pallor) Panduta (severe Pallor) shunakshikuta shotha( Peri orbital edema) Hritspandan ( Palpitations) Daurbalya(weakness) Shrama ( Fatigue) Aruchi(Anorexia) Kopan(Irritability) Shwasa(Dyspnea) Pindikodweshtan(Myalgia) 3)Minimum four or more sign and symptoms as per classics will be included in the study 4)Patients whose parents are willing to give consent for clinical study.

Exclusion Criteria

1. Hemoglobin Level lesser than 8gm Percent 2) Patient with iron therapy within 15 days prior to the screening 3) Patient with known cases of Hemoglobinopathies and blood disorders 4) Patient suffering from Anemia due to severe Blood Loss 5) Patient with Known case of Genetic disorder Congenital disease and Autoimmune Disorder malignancy cardiovascular disease hepatic and renal dysfunction Pulmonary disease gastrointestinal pathology any major systemic illness necessitating long term treatment 6) History of hypersensitivity to oral iron therapy or any Drug allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Study the Effect of Loha Gudhadi Gutika on Hemoglobin gm percent in iron Deficiency Anemia ( Panduroga) in Adolescent Girls	90 days

Secondary Outcome Measures

Name	Time	Method
To determine the tolerance and safety of Loha Gudhadi Gutika in iron Deficiency anemia in Adolescent Girls	90 days
To compare the Effectiveness of Loha Gudhadi Gutika and Tablet Ferrous sulfate in iron Deficiency Anemia ( Panduroga) in Adolescent girls	90 days

Trial Locations

Locations (1)

Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Sonia Madhukar Sawant

Principal investigator

9869262410

drsoniasawant3@gmail.com