A randomised open-labelled comparative clinical study to evaluate the efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in the Management of Garbhini Chardi With special reference to Hyperemesis Gravidarum.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1)The efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu will be established in the treatment of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
研究概览
简要总结
Maternal physiology during pregnancy phase is under continuous adaptation. Various physiological and psychological changes take place during pregnancy. Garbhini Chardi is one of the changes taking place in pregnancy and Ayurvedic classics have mentioned Garbhini Chardi as one among the Vyakta Garbha Lakshsana[1,2,3]. Chardi is seen as a Vyakta Garbha Lakshana and is considered as physiological condition when it is not associated with any deleterious effect on mother and it becomes pathological condition, when it causes deleterious effect on mother i.e.Hyperemesis Gravidarum. Hyperemesis Gravidarum is a condition causing severe nausea and vomiting in early pregnancy which may sometimes require hospitalization.[4]
According to previous work done, the prevalence of Hyperemesis Gravidarum is 1.66% [5]. Proper consumption of nutrients is very essential for the growth of fetus and well being of mother in early pregnancy, but due to intense nauseatic feeling, mother cannot take sufficient quantity of nutrients and it may cause dehydration, tiredness, weight loss which may affect the growth of fetus. In classics Acharyas have mentioned that Garbhini should be taken care like a pot filled with oil, as Garbhini Avastha is termed as delicate state, the Aushadis which are been given to her must have Sukh Sukumara properties[6]. Antiemetic drugs from contemporary medicine lack to have nutritive, appetizer properties in it.
In Yogaratnakara, individual drugs like Bilwa, Shunthi, Dhanayaka, Laja, Yava Saktu are mentioned in Chikitsa of Garbhini Chardi[7]. In Kashyapa Samhita, Mudga is mentioned in Chikitsa of Garbhini Chardi[8]. Antiemetic drugs from contemporary medicine lack to have nutritive, appetizer properties in it. In Yogaratnakara, individual drugs like Bilwa, Shunthi, Dhanayaka, Laja, Yava Saktu are mentioned in Chikitsa of Garbhini Chardi[7]. In Kashyapa Samhita, Mudga is mentioned in Chikitsa of Garbhini Chardi[8]. In Charaka Samhita, Bala is mentioned as a Prajasthapana Gana.[9]
A single formulation containing all these Dravyas is mentioned in Sahasrayogam and Yogaratnakara as well as these reference are present in Quality Control and Standardisation of Ayurvedic Medicine[10].
Bilwadi Kwatha withSharkara has properties like Deepana, Pachana, Rochana, Hridya, Chardihara, Dahaprashamana, Tarpana, Kapha-Vatahara as well as it has vitamin B-complex in it[11].
Shunthi Bilwa Kwatha with Yava Saktu has properties like Ruchivardhaka, Agnideepaka, Amapachaka and has carbohydrate which is easy for assimilation[12].
Since both the Yogas are in Kwatha form, easy to prepare, safe in pregnancy, acts as Chardi-hara and so this comparative study has been considered for the research work.
• Null Hypothesis (H0): There is no significant difference between effect of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
• Alternative Hypothesis (H1): There is significant effect of Bilwadi Kwatha with Sharkara when compared to Shunthi Bilwa Kwatha with Yava Saktu in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
• Alternative Hypothesis (H2): There is significant effect of Shunthi Bilwa Kwatha with Yava Saktu when compared to Bilwadi Kwatha with Sharkara in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Based on ICD-11 Diagnosis Code JA60.0 1)Subjects between the age group of 18-45years.
- •Subjects with gestational age upto 22 weeks.
- •Both multigravida and primigravida.
- •Subjects with PUQE-24(Pregnancy Unique Quantification of Emesis)score upto
- •Subjects with HELP(Hyper-Emesis Level Prediction)score upto
- •Subjects with twin pregnancies and singleton.
- •Subjects diagnosed with symptoms of Garbhini Chardi.
- •Subjects willing to sign the consent form.
排除标准
- •Subject with PUQE score more than or equal to 7 to
- •Subjects with HELP score more than or equal to 20 to
- •Subjects with molar pregnancy and other systemic illness like cardiac diseases, TB, etc.
- •Subjects with Diabetes Mellitus.
- •Subjects with Psychiatric illness.
- •Subjects with moderate to severe hypoglycemia, moderate to severe hyponatremia, moderate to severe dehydration as per scale.
- •Subjects with vomiting in pregnancy due to medical causes, surgical causes, gynecological causes.
结局指标
主要结局
1)The efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu will be established in the treatment of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
时间窗: treatment period - 14 days | study duration - 21 days
2)Significant decrease in the symptoms of Garbhini Chardi with special reference to Hyperemesis Gravidarum assessed based on PUQE score, HELP score and other subjective and objective parameters.
时间窗: treatment period - 14 days | study duration - 21 days
次要结局
- 1)To do literary review on Garbhini Chardi, Hyperemesis Gravidarum.(1 year)
研究者
Dr Shivangi Sanghvi
Sri Sri College of Ayurvedic Science and Research