Randomized controlled clinical trial to evaluate the efficacy of Gudadi mandur in the management of garbhini pandu (iron deficiency anemia in pregnancy)
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Hb % will increase
Overview
Brief Summary
Women are roota of progeny. Anemia is most commonest haematological disorder of pregnancy. During Garbhini Avastha increased fetal demands and improper functioning of Rasadhatu leads to Garbhini Pandu. Mother will not meet the extra demands of nutrients by diet alone. This lead to certain pathological condition in pregnant women. In addition, there is marked demand of extra iron during pregnancy specially in second half of pregnancy, even an adequate diet cannot provide the extra demand of iron. Thus, there is always remains a physiological iron deficiency state during pregnancy.
The general principle of treatment that all the disease of pregnant women should be treated by drugs and diet which are predominantly Mrudu ( soft), Madhur ( sweet), Sheeta ( cold), Sukhakar( palatable) . All the diseases should be treated by Sanshaman Chikitsa. Gudadi Mandur is one of such drug. Shunthi is Deepak, pachak and Raktashodhak. Pippali is Vrushya and Raktavardhak. Tila is Agnivardhak and Stanyajanak. Guda is Raktashodhak. Mandur Bhasma is considered as Raktavardhak.
Study will be conducted on 92 diagnosed patients of Garbhini Pandu ( Iron Deficiency Anemia in Pregnancy) . written consent will be taken. Initial assessment will be done. patients treated with Gudadi Mandur in interventional group and with Dhatri Lauha in control group.patient will be assessed at follow up. Observation and result will be noted and statistical analysis will be done. Discussion and conclusion will be done.
- Null hypothesis (Ho) - Gudadi Mandur is not effective in the management of Garbhini Pandu ( Anemia in Pregnancy)
- Alternate hypothesis ( H1)- Gudadi Mandur is effective in the management of Garbhini Pandu ( Anemia in Pregnancy)
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Diagnosed Patients Of Garbhini Pandu 2.Pregnant Women Of 21 TO 40 Years Age.
- •Patients In Between 14 Weeks To 30 Weeks Of Preganancy.
- •Hb% Above 7gm% And Below 10 gm%.
Exclusion Criteria
- •Patients Suffering From Severe Aenemia Hb Below 7 gm %.
- •Age Of Garbhini Below 21 Years And Above 40 Years.
- •Anemia Due To Major Disease , Known Case Of Thalassemia, Sickle Cell Anemia, Pernicious Anemia, Aplastic Anemia And Other Complications Like Bleeding Piles And Twin Pregnancy.
- •4.Any Other Obstetric Complication Like Pre-Eclampsia, Gestational Diabetes.
- •Patients With HbsAg , HIV, VDRL Positive.
- •Any Major Diseases that Interfere With The Corse Of Treatment.
Outcomes
Primary Outcomes
Hb % will increase
Time Frame: 1 month
Secondary Outcomes
- Lakshanas of garbhini pandu will dicrease.(2 months)
Investigators
Dr Rutuja Ramchandra Yamgar
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001