Randomized Controlled Trial to Evaluate the Efficacy of Kashmarya-Madhuka Granules Along with Yoga & Pranayama as an Aspect of Garbhasanskara in Second Trimester of Pregnancy.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Fetal wellbeing – assessed through fetal biometry with USG
研究概览
简要总结
This study is about a clinical evaluation of Kashmarya Madhuka granules along with YogaandPranayamaas an aspect of Garbhasanskara in the second trimester of pregnancy with routine antenatal care (ANC), in comparison to routine antenatal care (ANC) alone. There will be 2 groups in the study-
Group A (Trial group): Will receive Kashmarya-Madhuka granules (5g twice daily after meals with Godugdha) for 12 weeks along with Yoga and Pranayama as per national prenatal protocols with IFA tab (60 mg of elemental iron and 0.5 mg of folic acid) and Calcium tab (500 mg of Calcium with 250 I.U. Vitamin D3).
Group B (Control group): IFA tab (60 mg of elemental iron and 0.5 mg of folic acid) and Calcium tab (500 mg of Calcium with 250 I.U. Vitamin D3).
Trial will be conducted for a period of 12 weeks (3 months). Follow-up will be done every 15 days with final assessment after 12 weeks based on subjective symptoms, objective parameters and lab investigations.
Outcome assessment will include
Primary outcomes: Fetal growth parameters (BPD, HC, AC, FL, AFI) and maternal nutritional status (weight gain and MUAC).
Secondary outcomes: Changes in common pregnancy complaints, maternal stress levels (PSS scale), and incidence of complications such as IUGR and pre-eclampsia.
The data will be analysed scientifically and statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All pregnant women with known LMP between 13th -20th weeks of pregnancy.
排除标准
- •1.Patients with hemoglobin less than 7gm%.
- •2.Pregnancy with uterine malformations and congenital defect of uterus.
- •3.Multiple pregnancy.
- •4.Pregnancy with uterine fibroid and carcinoma.
- •6.Pregnancy with known case of epilepsy.
- •7.Pregnant women who is under antipsychotics.
结局指标
主要结局
1. Fetal wellbeing – assessed through fetal biometry with USG
时间窗: 12 weeks
2.Maternal wellbeing – assessed with Mid Upper Arm Circumference, Pregnancy Weight Gain etc.
时间窗: 12 weeks
次要结局
- 1.Changes in maternal minor ailments.(2.Changes in the rate of complications in the second trimester of pregnancy.)
研究者
Yogita Kumari
Madan Mohan Malviya Government Ayurveda College, Udaipur