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临床试验/CTRI/2026/01/100504
CTRI/2026/01/100504尚未招募2/3 期

Efficacy of Izkhar versus Mefenamic acid in primary dysmenorrhea- A Randomized Standard Controlled Trial

National Institute Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
50
试验地点
1

研究概览

简要总结

Patients diagnosed with primary dysmenorrhea will be randomly allocated in test (n = 25) and control (n = 25) groups after obtaining written informed consent. The study will be conducted in an open labelled manner. In test group, decoction of Izkhar will be prepared by soaking 10g in 200ml of water overnight. The infusion will be boiled the following morning until it reduces to half and will be administered orally on an empty stomach from D1-D5 of the menstruation for three consecutive cycles. In the control group, Mefenamic acid (500 mg) will be given SOS. Participants will be followed before and after menstruation during treatment and once after the completion of the treatment. Reduction in Visual Analogue Scale (VAS) and the Verbal Multidimensional Scoring System (VMSS) will be assessed during the study.

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
15.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Participants in the age of 15-35 years having painful menstruation of 1 to 2 episodes with VAS score (4-7) and VMSS score (1-2), with or without the associated symptoms (nausea, vomiting, fatigue, headache, giddiness, tenderness).

排除标准

  • Pelvic pathology like uterine fibroid, endometriosis, adenomyosis, PID, PCOD, Systemic illnesses like HTN, DM, malignancies, Acute abdominal conditions like Peritonitis, Appendicitis, Renal and GB calculi, Heavy menstrual bleeding and severe anemia.
  • Pregnant and lactating women Ectopic Pregnancy.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nahid Parveen

National Institute Of Unani Medicine

研究点 (1)

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