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临床试验/CTRI/2024/01/060987
CTRI/2024/01/060987尚未招募2 期

Comparative study of Tukhm-e -Bartang with Tranexamic acid in Kathrat-i-Tamth (Heavy Menstrual Bleeding)

Government Unani Medical College & Hospital Bangalore-5600791 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月8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
Decrease in menstrual pictogram score.

研究概览

简要总结

Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss which interferes with a woman’s physical, social, emotional and/or material quality of life, which can occur alone or in combination with other symptoms. It is quantitatively described as menstrual blood loss of 80 ml or more every cycle . Heavy menstrual bleeding is one of the most common gynecological problems, the occurrence of which increases with age. More than 30% of women of reproductive age group and 60% of the total women population experience it. In Unani system of medicine Kathrat-i-Tamth is described as increased menstrual blood loss either in amount or in duration. It is mainly caused due to Su-i-Mizaj al Rahim or Duf-i-rahim. In conventional system of medicine, a wide variety of treatment modalities are now available. First line of treatment includes Hormonal [LNG-IUS, combined hormonal contraception, cyclic oral progestogen] and Non-hormonal (Tranexamic acid, NSAID’S). If this fails surgical intervention, is required . Hysterectomy provides a definitive cure for heavy menstrual bleeding. However, the recent literature more often relays on less invasive and simpler techniques that decrease morbidity and preserve fertility. The costs of HMB  related surgery are high and economic burden on the patient. Hence herbal or traditional medicines provides cost effective and risk-free treatment option. In Unani system of medicine single drugs such as Bartang, Anjabar, Geru, Sange jarahat, Dammul Akhwain and compound formulations like Qurs-e-kohrba, Qurs-e-kafoori, Majoon-e-busad, Safoof habis etc. are used in the treatment of Kathrat-i-Tamth . Tukhm-e-Bartang is selected to evaluate its efficacy in Kathrat-i-Tamth as it exhibits the properties of Habis, Qabis, Moharrik, Muaddil. Considering all the above-mentioned facts it has been decided to conduct a comparative study of Tukhm-e-Bartang with Tranexamic acid in Kathrat-i-Tamth (Heavy Menstrual Bleeding).

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 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients of reproductive age group 18- 45yrs.
  • Patients with regular menstrual cycle with amount of flow more than 80ml and/or duration of flow more than 7 days.
  • Patients with pelvic pathology like Uterine fibroids less than 3 cms and adenomyosis.
  • Patients with IUCD.

排除标准

  • Patients with (uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction).
  • Severe anemia with Hb% less than 7mg/dl.
  • Uterine fibroids more than 3cms.
  • Patients on OCP’S, or any other hormonal therapy.
  • Patients with blood dyscrasias and malignancy.

结局指标

主要结局

Decrease in menstrual pictogram score.

时间窗: Before and after mensturation for 3 months.

次要结局

  • Improvement in SF-12 scale for quality of life.(Improvement in Hb%.)

研究者

发起方
Government Unani Medical College & Hospital Bangalore-560079
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sumaiya Kouser

Government Unani Medical College and Hospital

研究点 (1)

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