Efficacy of Waj in premenstrual syndrome: A randomized placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
研究概览
简要总结
Diagnosed cases of premenstrual syndrome fulfilling the inclusion criteria will be randomly allocated to the test and control groups. Written informed consent will be obtained from the participants. Participants and the researcher will be blinded in the study, and blinding will be done by third person. The research drug will be given to the participants in capsule form during the luteal phase of the menstrual cycle for 3 consecutive cycles. Participants will be followed every month, 10 days prior to menstruation during treatment and once after menstruation following the completion of treatment. Reduction in VAS and PMTS scores will be assessed during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 35.00 Day(s)(—)
- 性别
- Female
入选标准
- •Participants in the age group of 18-35 years with regular menstrual cycle (21-35 days).
- •Participants fulfilling the ACOG criteria of PMS (such as abdominal bloating, breast tenderness or swelling, headache, joint or muscle pain, swelling of the extremities, and weight gain, as well as mental symptoms, including angry outbursts, anxiety, confusion, depression, irritability, and social withdrawal) with at least 1 somatic and 1 mental symptom with moderate to severe intensity.
排除标准
- •Participants with Any pelvic pathology such as uterine fibroids, ovarian cyst, endometriosis etc Use of oral contraceptives in past 3 months and underwent hysterectomy.
- •K/C/O DM, HTN, thyroid dysfunction.
- •Depression- PHQ-9 Pregnant and Lactating women.
研究者
Rifat Jahan
National Institute Of Unani Medicine
