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临床试验/CTRI/2020/02/023357
CTRI/2020/02/023357尚未招募2 期

Effect of Qurs-i-Shibb in Kathrat-i-Tamth (HMB): An observational clinical study.

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Decrease in Bleeding

研究概览

简要总结

Title of study: Effect of Qurs-i-Shibb in Kathrat-i-TÌ£amth (HMB): An observational clinical study*.* Menorrhagia is a Greek word, derived from two words; men means menses and rrhagia means burst forth.It is generally defined as excessive bleeding, either in duration or quantity of blood loss or both (> 8 days and/or >80 ml) at regular intervals.In Unani system of medicine several single drugs such as bartang, tabasheer,shibbe yamani, khurfa, geru, sange jarahat, damul akhwain, rasaut and compound drugs are safoofe habis, majoone busd,qurse gulnar, qurse kahruba, sharbate injebar, Qurs-i-Shibb etc*.* are available to control heavy bleeding and are more convenient being administered and more over it is non-hormonal treatment. Among these drugs Qurs-i-Shibbis selected to evaluate its efficacy in the management of Kathrat-i-TÌ£amth. Procedure of the study:Diagnosed cases of Kathrat-i-TÌ£amth will be informed about the study procedures and written consent will be obtained. Orally Qurs-i-Shibb two tablets will be administrated thrice daily for 5 days from day 1 of cycle for 2 cycles. Follow up of patient will be done before and after each cycle for 2 consecutive cycles during trial and one follow up after completion of trial.

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

  • •1-Women between the ages of 18-40 Years.
  • •2-Regular cycles with heavy bleeding in duration or amount of flow or both.

排除标准

  • •Patients with 1-Hb less than 8.5 gm%.
  • •2-H/o systemic diseases and blood dyscrasia.
  • •3-H/o of pelvic pathology and malignancy.
  • •4-H/o of OCPs,IUCD insertion in last 3 months.

结局指标

主要结局

Decrease in Bleeding

时间窗: One and half year

(amount/ duration)

时间窗: One and half year

次要结局

  • Change in(1-PBAC Score(100))

研究者

申办方类型
Research institution and hospital

研究点 (1)

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