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临床试验/CTRI/2025/12/099612
CTRI/2025/12/099612尚未招募2/3 期

Efficacy of Mazoo Versus Tranexamic Acid in Heavy Menstrual Bleeding: 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 46 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
46
试验地点
1

研究概览

简要总结

Heavy menstrual bleeding (HMB) is defined as menstruation that occurs at regular intervals but is characterized by excessive blood loss exceeding 80 mL per cycle or lasting more than seven days. ¹ HMB adversely affects women’s quality of life by interfering with their daily routines, work performance, lifestyle, and social engagements.  According to estimates by the World Health Organization (WHO) approximately 18 million women globally suffer from HMB. Throughout their reproductive years, about 10%–35% of women seek medical consultation for symptoms of HMB,with 5% requiring active medical intervention. In developing countries, the reported prevalence of HMB ranges between 8% and 27%.

In conventional medicine, a wide variety of treatments have been suggested for HMB including oral contraceptive pills, progestin-containing intrauterine contraceptive devices (IUCDs), nonsteroidal anti-inflammatory drugs (NSAIDs), tranexamic acid, Gonadotrophin releasing hormone (GnRH) agonist, and surgical options include endometrial ablation, dilatation and curettage, uterine artery embolization (UAE) and hysterectomy.However, these therapies may cause adverse effects such as gastrointestinal discomfort, hepatic dysfunction, weight gain, and thromboembolic events. Hypoestrogenic side effects of hormonal treatments can lead to rapid bone resorption and menopausal-like symptoms including vaginal dryness and hot flushes, further compromising the quality of life.

In conventional medicine a wide variety of treatments have been suggested for HMB including oral contraceptive pills, progestin-containing intrauterine contraceptive devices (IUCDs), nonsteroidal anti-inflammatory drugs (NSAIDs), tranexamic acid, Gonadotrophin releasing hormone (GnRH) agonist and surgical options include endometrial ablation, dilatation and curettage, uterine artery embolization (UAE) and hysterectomy.However, these therapies may cause adverse effects such as gastrointestinal discomfort, hepatic dysfunction, weight gain, and thromboembolic events. Hypoestrogenic side effects of hormonal treatments can lead to rapid bone resorption and menopausal-like symptoms, including vaginal dryness and hot flushes, further compromising the quality of life. As a result, there is a growing need for safer, well- tolerated, and effective alternative treatments especially those derived from medicinal plants, which continue to play a significant role in traditional healthcare systems.

In recent decades, there has been an increasing global inclination toward the use of complementary and herbal medicines for the management of chronic conditions. Herbal medicine, a key component of traditional medical systems, is gaining popularity due to the widespread belief in the efficacy and safety of medicinal plants in conditions like HMB. Classical Unani literature describes several single drugs with proven efficacy in managing HMB, including Habbul Aas, Gulnar, Dammul Akhwayn, Kahruba, Gil-e-Makhtoom, and Mazoo.Among these, Mazoo (Quercus infectoria, gall oak) has been selected to evaluate its efficacy scientifically in patients with HMB due to its multiple therapeutic properties, such as Habis (styptic), Qabid (astringent), Muqawwi (tonic), Mujaffif (desiccant), Mundamil Qarih (wound-healing), and Mohallil-e-Waram **(**anti- inflammatory)

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Participants in the age group of 18-45 years with regular cycles (21-35 days) with (DOB)more than7 days and PBAC scores more than 100 for 2 out of 3 consecutive cycles.
  • Participants with thickened endometrium up to 18 mm adenomyosis uterine fibroids less than 3 in number and less than 3 cm in size Participants with mild (Hb levels 11-11.9g/dL) to moderate (Hb levels 8 to 10.9.9g/dL) anemia.

排除标准

  • K/C/O HTN DM and hypothyroidism.
  • Bleeding disorders severe anemia (Hb less than 8gm) and malignancy.
  • Hormonal contraceptives in last 3 months.

研究者

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

Hiba Fatima

National Institute Of Unani Medicine

研究点 (1)

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