A Randomized Comparative Study of Sharbat Tamarhindi Versus Doxylamine Succinate in Emesis Gravidarum (Qay-al-haml)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in severity of nausea and vomiting by PUQE index.
研究概览
简要总结
Emesis gravidarum also known as nausea and vomiting in pregnancy (NVP) It is a common condition with prevalence rates for nausea of 50–80% and for vomiting and retching of 50%.[1,2] It is a common reason for hospital attendance and admission in the pregnant woman.[3],[4] The beginning of emesis gravidarum is highly variable and is usually between the first and second missed menstrual cycle; it continues to 14 to 16 weeks of pregnancy and usually has the most severity from 7 to 9 weeks of pregnancy. In 50% of women, NVP resolves by the 14 weeks and in 90 percent of women by the 22 weeks.[5] NVP have significant adverse effect on the quality of women’s life.[4,6] NVP and their exact causes are still unknown so that hormonal, social, personal, psychological, racial and geographical factors are believed to be involved in their occurrence.[1,7] Treatment of nausea and vomiting also can be unsatisfactory because the available pharmacotherapy does not correct the fundamental underlying pathophysiological abnormalities.[8] Although there is medication available to treat NVP, some physicians and patients are reluctant to use these drugs due to reports of fetal malformations associated with antiemetic medications.[9] Ondansetron was quickly adopted as a first-line antiemetic for other causes of nausea and vomiting, including NVP.[10] A possible association between ondansetron use in the first trimester and cleft palate has been reported.[11] Concerns about teratogenicity in the first trimester and more subtle effects on foetal development have dramatically limited the use of orthodox medicine.[12] Pregnant women often use medicinal herbs in an effort to maintain good health and reduce the need for medical intervention.[5,13] The term used for emesis gravidarum in Unani literature is Qay’al-hawamil.[14] And to treat this condition, Unani scholars have been described several safe drugs which have been mentioned for oral administration in a form of single drug as well as compound formations, like some basic single drug are Zanjabeel (Ginger), Amla (Gooseberry), Anar (Pomegranate), Leemu (Lemoon) and Tamarhindi (tamarind).[15] And compounds are sikanjabeen-e-sada, jawarish-e-anarain, jawarish-e-tamarhindi, sharbat-e-anar, sharbat-e-lemu, shikanjabeen-e-tamarhindi and sharbat-e-tamarhindi.[14,16] Among of all Sharbat-e-tamarhindi is an important antiemetic drug used in management of emesis in pregnancy in unani medicine.[14,16,17] Various study shown that tamarhindi ‘Tamarindus Indica’ has antiemetic property which help to treat emesis gravidarum, astringent, anthelmintic, antiseptic, healing, antimicrobial and antiviral properties.[18] Considering this facts it has been decided to conduct the clinical trial to evaluate the safety and efficacy of Sharbat-e-tamarhindi in comparison with doxylamine succinate in patient with nausea and vomiting in pregnancy.
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
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Primigravida and Multigravida between the age of 18 to 35 years.
- •2.Gestational age of 6 to 14 week.
- •3.Mild to moderate NVP (3 to 12) score on the PUQE 24 scale.
- •4.No intake of anti-nauseant drug within at least 24 hours before visit.
排除标准
- •1.Patients with hyperemesis gravidarum.
- •2.Patients in whom emesis seen in second and third trimester.
- •3.Patients with twin pregnancy and vesicular mole.
- •4.Vomiting caused due to other disorders like peptic ulcer, renal calculi, appendicitis, gastritis, malignancies.
- •5.Patients with systemic diseases.
结局指标
主要结局
Reduction in severity of nausea and vomiting by PUQE index.
时间窗: two follow ups weekly on 5 and 6 week
次要结局
- Improvement of quality of life by NVPQOL questionnaire.(two follow ups weekly on 5 and 6 week)
研究者
PATHAN SANA AFROZ MD SHAFI
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Vijaypur, Karnataka 586101
