A Randomized open-labelled controlled clinical study to evaluate the efficacy of Garbhini Ksheerapakas for Garbha Poshana in 7th, 8th & 9th month of pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- -Improvement in Subjective symptoms: Fatigue, Pedal Oedema, Backache, Heart Burn, Malapravritti, Heaviness of body (Anga Gourava)
研究概览
简要总结
Pregnancy is one of the crucial phase in a woman’s life during her journey towards motherhood. As per a recent National survey study in India, it was estimated that 1.3 million Indian women have died from maternal causes over the last two decades.
Maternal health is maintained by following Garbhini Paricharya i.e., a systemic lifestyle and diet regimen along with various Ayurvedic formulations told in the classics. Along with Masanumasika Pathya, Garbhini Paricharya includes Garbhasthapaka Dravyas or drugs which are beneficial for the maintenance of Pregnancyand Garbhopaghatakara Bhavas which lists the factors that are harmful to the foetus and should be avoided by the pregnant woman.
Sahasrayogam and Arogyakalpadruma are two important Ayurvedic texts which have exclusive references on Garbhini Ksheerapakas. As per this reference, different drugs in the form of Ksheerapaka are advocated month-wise throughout pregnancy.
In the 7th month, Yava Siddha Ksheerapaka is advised as it is a good source of micro and macro-nutrients maintaining adequate Garbha Poshana and actively stimulates foetal development especially lungs and kidney. As it is bulk promoting it helps to relieve constipationand due to its diuretic effect, it relieves pedal oedema which is commonly seen in the third trimester.
Morata Siddha Ksheerapaka is told for the 8th month as it acts as Tridosha Shamana and has anti-bacterial properties. Morata is proved to act as a skeletal muscle relaxant and thereby relieves backpain due to the increasing weight of the gravid uterus.
Asthe ninth month begins, the woman enters to her Prasava Kala. Shatavari Siddha Ksheerapaka due to its Madhura Rasa and MadhuraVipaka acts as a good galactagogue and has immunomodulatory effect.
Hence, this study is intended to evaluate the efficacy of Garbhini Ksheerapakas for Garbha Poshana in the 7th, 8th and 9th month of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravida and Multigravida 2) Subjects who have just completed 24 weeks of gestational age.
- •Subjects having haemoglobin value of 10 g/dL or more.
- •Subjects who are willing to give written consent for the study.
排除标准
- •Subjects up to 24 weeks of gestational age.
- •Systemic diseases like Hypertension, Diabetes Mellitus, Severe Anaemia, Thyroid disorders.
- •High risk pregnancies like Pre-eclampsia, Gestational Diabetes, Ante-partum Haemorrhage, Polyhydramnios.
结局指标
主要结局
-Improvement in Subjective symptoms: Fatigue, Pedal Oedema, Backache, Heart Burn, Malapravritti, Heaviness of body (Anga Gourava)
时间窗: Pre-test Assessment- 0th Day (Before 28 weeks) | 1st Assessment- After completion of 28 weeks | 2nd Assessment- After completion of 30 weeks | 3rd Assessment- After completion of 32 weeks | 4th Assessment- After completion of 34 weeks | 5th Assessment- After completion of 36 weeks | 1st Follow up- Weekly once till delivery after 36 weeks | 2nd Follow up- At the time of Delivery | 3rd Follow up- 7 days post delivery
-Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index
时间窗: Pre-test Assessment- 0th Day (Before 28 weeks) | 1st Assessment- After completion of 28 weeks | 2nd Assessment- After completion of 30 weeks | 3rd Assessment- After completion of 32 weeks | 4th Assessment- After completion of 34 weeks | 5th Assessment- After completion of 36 weeks | 1st Follow up- Weekly once till delivery after 36 weeks | 2nd Follow up- At the time of Delivery | 3rd Follow up- 7 days post delivery
-Mode of Delivery- Normal delivery
时间窗: Pre-test Assessment- 0th Day (Before 28 weeks) | 1st Assessment- After completion of 28 weeks | 2nd Assessment- After completion of 30 weeks | 3rd Assessment- After completion of 32 weeks | 4th Assessment- After completion of 34 weeks | 5th Assessment- After completion of 36 weeks | 1st Follow up- Weekly once till delivery after 36 weeks | 2nd Follow up- At the time of Delivery | 3rd Follow up- 7 days post delivery
次要结局
- -Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index(-Mode of Delivery- Normal delivery)