A SINGLE ARM NON-RANDOMISED STUDY ON THE COMBINED EFFECTOF PUNARNAVADI YOGA AND RUDRAKSHA LEHANA INGARBHAVASTHAJANYA UCHCHA RAKTA CHAPA VIS-A-VIS GESTATIONAL HYPERTENSION
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
- Reduction in high blood pressure
研究概览
简要总结
Hypertensive disorders of pregnancy occur in about 10% of all pregnant women around the world.
Preeclampsia is a complication of gestational hypertension which affects 3–5% of pregnancies. In Asia and
Africa, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy. In India,
the incidence of preeclampsia is reported to be 8%-10% among the pregnant women. According to a study, the
prevalence of hypertensive disorders of pregnancy was 7.8% with preeclampsia in 5.4% of the study population
in India. 1 Young and nulliparous women are particularly vulnerable to developing preeclampsia, whereas older
women are at greater risk for chronic hypertension with superimposed preeclampsia. The incidence is markedly
influenced by race and ethnicity—and thus by genetic predisposition.
Diseases of pregnant woman due to foetus are called as ‘Garbhopadrava’ or ‘Garbhini vyadhi’ in
Ayurveda. Garbhini shotha (oedema) is one of the Garbhopadrava mentioned in our Ayurvedic classics.
Oedema of pregnancy may be of different origin. Ayurveda has described ‘Garbha Sampidana ’ as a causative
factor of Shotha (oedema) of pregnancy. Shotha is one of the symptoms in gestational hypertension. As there is
no actual description of garbhavasthajanya uchcha raktachapa in our Ayurvedic classics, the same has been
used as a coined term.
Early detection and appropriate treatment are the need of the hour to reduce the maternal and fetal
mortality and morbidity. The standard protocol of anti-hypertensive drugs though highly effective and lifesaving
has its own side effects that include fatigue, lethargy, exercise intolerance, sleep disturbance, bronchoconstriction
etc,.
Hence, an effective formulation in Ayurveda which is devoid of harmful drug interactions and side
effects will be of immense help for women of present era and needless to say for the foetus. In this study Punarnavadi yoga is an anubhuta yoga
containing Punarnava, Darbha and Gokshura along with Rudraksha kalka lehana which aims to manage the
gestational hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Primi and multi gravida Pregnant women having Blood Pressure – 140/90 – 160/110 mmHg after 20 weeks of gestation.
排除标准
- •Pregnancy associated with any gynecological complications that will interfere with the course of study.
- •Pregnancy associated with any Obstetric complications that will interfere with the course of study.
- •Pregnancy associated with Proteinuria: more than 3+.
结局指标
主要结局
Reduction in high blood pressure
时间窗: 7 DAYS
次要结局
未报告次要终点
