Evaluation of add on clinical efficacy of Masanumasik Dietary regimen as Garbhini Rasayana in 4th-7th month of Pregnancy: A randomised control trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Garbhini Masanumasika Paricharya on foetal growth parameters and maternal wellbeing (maternal weight gain)
研究概览
简要总结
Contemporary medicine typically addresses prenatal nutritional deficiencies through targeted supplementation (e.g., iron, calcium, folate). In contrast, traditional Ayurvedic medicine emphasizes a holistic approach, focusing on enhancing overall digestive function and utilizing natural substances considered ’Rasayanas’ to promote maternal and fetal health. [i] Rasayanas are believed to provide enhanced nutrition and support optimal biological function.
Systematic prenatal care, known as Garbhini Masanumasik Pathya in Ayurveda, involves the regular monitoring of a pregnant woman’s health through counseling on diet, lifestyle, and other factors.[ii]
This personalized care should begin early in pregnancy and continue until childbirth. Optimal Garbhini Paricharya supports healthy foetal development, maternal wellbeing, a successful delivery, and a smooth postpartum recovery. Ayurvedic texts prescribe specific dietary regimens and lifestyle recommendations tailored to each month of pregnancy, emphasizing the crucial role of nutrition in prenatal care.
Primary objective
To evaluate the effect of Garbhini Masanumasika Paricharya on foetal growth parameters and maternal wellbeing (maternal weight gain) during 4-7th month of pregnancy
Secondary objective
To evaluate the effect of Garbhini Masanumasika Paricharya on-
· nausea and vomiting
· Constipation
· Insomnia
Fatigue
· Oedema
| STUDY DESIGN |
Open label Randomised Clinical Trial
|RANDOMISATION
Computer generated randomisation
|TIMING
Prospective
|SAMPLE SIZE
28 in each group
|NUMBER of GROUPS
2
|PURPOSE
Analysis
|DURATION OF STUDY
120 Days
|FOLLOW UP
Every 15th day during the course of intervention
and once after delivery
·
| **Before | |
| intervention** |
After intervention
|CBC with ESR
CBC with ESR
|Lipid profile
Lipid profile
|FBS
Serum Calcium
|Serum Calcium
USG (Obs.)(COLOUR DOPPLER)( After 28th week)
|Sr. protein
Sr. protein
|Omega 3 fatty acid, Omega 6 fatty acid
Omega 3 fatty acid, Omega 6 fatty acid
|USG (Obs.) (NT/NB) (At 10th -12th week)
|LFT, KFT
| GROUPS |
INTERVENTION
DOSAGE
Anupana
TIME
DURATION
|Control
Calcium (elemental)
Iron (elemental)
200 mg (orally)
30 mg
(Orally)
Water
BD
120 Days
|Trial
Calcium (elemental)
Iron (elemental)
200 mg
(Orally)
30 mg
(Orally)
Water
BD
120 Days
|4th Month – Ksheer (with Shunthi powder 250 g) + Navneet
5th Month – Ksheer (with Shunthi powder 250 g) +
Sarpi
6th and 7th Month – Shatavari Siddha Ghritam
200 ml[i]
10 gms
(Orally)
200 ml
10 ml
(orally)
10 ml
(orally)
BD
30 days
30 days
60 days
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
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primi gravida with gestational age 11-12 weeks.
- •Age group 20 -35 years.
- •Able and willing to participate and provide signed informed consent.
排除标准
- •Pregnant women with Dyslipidemia, Deranged LFT, Hemoglobin less than 7gm/dl, severe systemic disease, uncontrolled hypertension (Bp greater than or equal to 140/90mmhg), diabetes mellitus (FBS more than 100mg/dl).
- •Diagnosed cases of disorders of reproductive tract like tuberculosis, carcinoma, and uterine fibroid and STDs.
结局指标
主要结局
To evaluate the effect of Garbhini Masanumasika Paricharya on foetal growth parameters and maternal wellbeing (maternal weight gain)
时间窗: 28th week and 40th week of ante natal period
次要结局
- To evaluate the effect of Garbhini Masanumasika Paricharya on-(• nausea and vomiting)
研究者
Richa Rani
All India Institute of Ayurveda (AIIA)