Evaluation of the efficacy of Mandura Makshika Bhasma in the management of Garbhini Pandu w s r to Iron deficiency anaemia in pregnancy a Randomized controlled clinical trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Improvement in hematological parameters and clinical
Study Overview
Brief Summary
Anaemia affects 52 percentage of pregnant women in India with Iron Deficiency Anaemia IDA responsible for about half of these cases contributing significantly to maternal and perinatal complications
Conventional treatment involves oral iron supplements which are effective but often poorly tolerated due to gastrointestinal side effects leading to low adherence
Parenteral iron therapy is faster but expensive and risky
In Ayurveda although Garbhini Pandu isnt directly mentioned related conditions like Vivarnata and Pandutwa are discussed
Traditional Ayurvedic medicines like Mandura Bhasma and Swarna Makshika Bhasma have been used to manage anaemia
A unique formulation Mandura Makshika Bhasma combines both enhancing therapeutic effects especially for severe pitta related conditions
Despite the availability of modern formulations like ferrous ascorbate side effects and poor bioavailability remain issues
Limited research exists on the combined effects of Mandura and Swarna Makshika Bhasma This study aims to explore their synergy absorption and potential as an effective Ayurvedic alternative for managing IDA in pregnancy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Confirmed diagnosis of Mild Iron Deficiency Anaemia 9 to 10 point 9 g per dl as per WHO criteria Pregnant women in early second trimester between 14 weeks to 20 weeks 6 days Age group 18 to 40 years Singleton intrauterine pregnancy Willingness to participate.
Exclusion Criteria
- •Moderate to Severe Anaemia Moderate 7 to 8 point 9 g per dl Severe less than 7g per dl Anaemia due to other causes such as megaloblastic anaemia thalassemia or sickle cell anaemia Multiple pregnancy Gestational age less than 14 weeks or more than 21 weeks Chronic metabolic disorders hypertension diabetes hepatic and renal diseases GDM PIH Bleeding disorders like piles peptic ulcer oesophageal varices.
Outcomes
Primary Outcomes
Improvement in hematological parameters and clinical
Time Frame: Baseline 22nd Day and 45th Day
symptoms of Garbhini Pandu
Time Frame: Baseline 22nd Day and 45th Day
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pragya Singh
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya