跳至主要内容
临床试验/CTRI/2025/01/079255
CTRI/2025/01/079255招募中不适用

Efficacy of Hijama Bila Shart and Tukhm Bartang versus Tranexamic Acid in Women with Kathrat-i-Hayd.

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
1
主要终点
PBLAC (Pictorial Blood Loss Assessment Chart)

研究概览

简要总结

Heavy menstrual bleeding (HMB) is diagnosed as excessive or prolonged uterine bleeding per menstruation of more than 80 ml or for 7 days in a normal cycle. According to the traditional Unani texts, excessive menstrual blood loss (MBL) with regular cycles and excessive bleeding, either in volume or length, are the characteristics of heavy menstrual bleeding (HMB).  An alternative semiquantitative technique for evaluating MBL makes use of a pictorial blood loss assessment chart (PBLAC). Menorrhagia can be effectively treated using a variety of herbs and regimental therapy, such as dry cupping, which is part of the Unani medical system. Plantago major, commonly known as great plantain or Tukhm Bartang in Unani medicine, belongs to the Plantaginaceae family. Tukhm Bartang has been chosen as a study drug among the various medications accessible for HMB. It possesses Syptic, detergent, Musakkin, and others.  It contains several active compounds, i.e. phenolic acids, flavonoids, tannins, polysaccharides, terpenoids, lipids, iridoid glycosides, and caffeic acid derivatives. Application of dry cupping below the breast is also useful to control heavy menstrual bleeding. The hypothesis of the study will be dry cupping and Tukhm Bartang versus tranexamic acid in HMB will be effective at post-intervention. The objective of the study is to determine and compare the efficacy of dry cupping and Tukhm Bartangversus tranexamic acid in HMB.  Diagnosed cases of HMB fulfilling the inclusion criteria will be randomly selected. Written informed consent will be obtained from patients. The drug will be given either to the test or control group. In the test group, 5g of Tukhm Bartang will be given in three divided doses for five days and dry cupping for 3 days from the first day of menstruation for 3 consecutive months. Patient global assessment of tolerability to therapy will be assessed for safety and tolerability to therapy at the end of the treatment.  PBLAC, and Samanta questionnaire will be assessed at baseline and each follow-up. MIQ (Menorrhagia Impact Questionnaire) and Haemoglobin percentage will be assessed at baseline and at the end of the intervention. The total sample will be 62 patients (31 in each group).  The Primary outcome will be assesdPBLAC (Pictorial Blood Loss Assessment Chart). The secondary outcome will be Samanta questionnaire, MIQ (Menorrhagia Impact Questionnaire), and Haemoglobin percentage. The appropriate tests will be applied to analyse the data. Descriptive statistical analysis will be used in the study. Results on continuous measurements will be presented in mean (SD) and results on the categorical measurements will be presented in number (percentage) with a 5 percent  level of significance and 95 percent confidence interval.

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 42.00 Year(s)(—)
性别
Female

入选标准

  • Study participants in the age group of 18-42 years with regular cycles (21-35 days) with MBL greater than 80 ml or DOB greater than 7 days for 2 out of 3 consecutive cycles.
  • Study participants with PBAC scores greater than 80ml and Samanta scores more than
  • Study participants with thickened endometrium up to 18 mm, adenomyosis,uterine fibroids less than 3 in number and less than 3 cm in size.
  • Study participants with mild (Hb levels 11-11.9g/dL) to moderate (Hb levels 8 to 10.9.9g/dL) anemia.

排除标准

  • Study participants with co-morbidities such as uncontrolled hypertension (Stage 2 hypertension more than 140/90 mmHg), uncontrolled diabetes mellitus (FBS more than 130mg/dl or PPBS more than 180mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00%), uncontrolled hypothyroid, Bleeding disorders, severe anaemia (Hb less than 8gm%) and malignancy.
  • Hormonal contraceptives in last 3 months.
  • Study participants with uterine fibroid more than 3 in number and more than 3 cm in size.

结局指标

主要结局

PBLAC (Pictorial Blood Loss Assessment Chart)

时间窗: PBLAC (Pictorial Blood Loss Assessment Chart) will be assessed at baseline, week 4, 8, 12 and week 16

次要结局

  • Samanta questionnaire, MIQ (Menorrhagia Impact Questionnaire), Haemoglobin percentage(The secondary outcome Samanta & MIQ will assessed after menstruation at baseline, week 4, week 8, 12 & week 16. Haemoglobin percentage will be assessed at baseline & week 12.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ramsha Arshad

National Institute of Unani Medicine

研究点 (1)

Loading locations...

相似试验