跳至主要内容
临床试验/CTRI/2024/08/072939
CTRI/2024/08/072939尚未招募2 期

A Randomized Comparative Study of Sharbat Tamarhindi Versus Doxylamine Succinate in Emesis Gravidarum (Qay-al-haml)

Luqman Unani Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月29日最近更新:

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

发起方
Luqman Unani Medical College Hospital and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

PATHAN SANA AFROZ MD SHAFI

Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Vijaypur, Karnataka 586101

研究点 (1)

Loading locations...

相似试验