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临床试验/CTRI/2021/01/030184
CTRI/2021/01/030184已完成不适用

Effect of ShiyÄf of Gond-i-Babul and Kafoor in Kathrat-i-Hayd (Heavy Menstrual Bleeding)-A Randomized Controlled Study

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in Pictorial Blood Loss Assessment Chart (PBAC) score for menstrual blood loss

研究概览

简要总结

Kathrat-i-Haydor Ifraat-i-Hayd meansis excessivemenstrual blood loss either in amount or duration.Heavy menstrual bleeding (HMB) or menorrhagia isone of the most frequently encountered symptoms in gynaecology. It is definedas menstruation periods at regular cycle but with an excessive flow which maylast more than 7 days. Menorrhagia can cause menstrual bleeding of more than 80ml in each cycle..Heavy menstrual bleeding (HMB) is a benign yetdebilitating social and health condition.Medical management for HMB in conventional medicine hasdifferent side effects such as gastrointestinal symptoms, liver disease,obesity, and thromboembolic diseases. Moreover, hypoestrogenic state as a sideeffect of these therapies can lead to rapid bone demineralization andmenopausal symptoms such as vaginal dryness and hot flushes and so on, whichreduce the quality of life.Unani medicine is the oldest system that prevails till datewith its effective remedies. Shabat-i-Anjabar, Qurs-i-Habis,Gulnarband Hijama bila Sharthavebeen validated and clinically proven for their effectiveness in Kathrat-i-Hayd. However, none of thestudies has evaluated the effect of ShiyÄfof Gond-e-babul (Acacia arabicaLinn)and Kafoor (Cinnamomumcampora Linn) in Kathrat-Hayd. Therefore, the objective of the present study will be to evaluate and validate the effect of ShiyÄf  of Gond-i-Babuland Kafoorin Kathrat-i-Haydas they possess Habis wa Qabiz and Muhallil properties. The efficacy of thetest and control drug will be assessed by Pictorial Blood Loss Assessment Chart(PBAC) score for menstrual blood loss and SF-36 HRQoL questionnaire to assess thequality of life.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •Women with regular cycles (21-35 days) with Kathrat-i-Hayd (heavy bleeding) in duration (more than 7 days) or amount of flow (>80 ml) or both.

排除标准

  • •Pelvic pathology (uterine fibroids >3cms and/or >3 in number, polyp, PID) and malignancy Diagnosed cases chronic renal, liver disease, uncontrolled HTN and uncontrolled DM) and endocrine diseases (thyroid dysfunction) Bleeding disorders, severe anemia (Hb <7gm%) H/O hormonal contraceptives in last 3 months.
  • •Pregnant and lactating mother.

结局指标

主要结局

Change in Pictorial Blood Loss Assessment Chart (PBAC) score for menstrual blood loss

时间窗: Every month for 4 months after completion of menstrual phase of menstrual cycle

次要结局

  • Change in SF-36 HRQoL questionnaire to assess the quality of life.(At baseline and at fourth menstrual cycle)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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