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临床试验/CTRI/2024/11/076920
CTRI/2024/11/076920尚未招募2 期

A Randomized Comparative Study of Safūf Ḥābis and Ḥijāma bilā Sharṭ Versus Placebo and Ḥijāma bilā Sharṭ in Kathrat-i-Hayd (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 60 人开始时间: 2024年11月30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
60
试验地点
1
主要终点
Change in Pictorial Blood loss Assessment Chart PBAC

研究概览

简要总结

In Unani System of Medicine, Heavy Menstrual Bleeding is termed as *Kathrat-i-Tamth/ Kathrat-i-Hayd /Khun-i-Hayd /Ifrāṭ rawangi /Sailan-i-Hayd.*According to the classical Unani literature Heavy menstrual bleeding occurs due to  Sū’i-Miẓaj- i-Rahim Sada or Maddi (deranged temperament of uterus), Weakness in Quwwat Māsika or increase in  Quwwat Dāfi‘a, Imbalance in Akhlāṭ -i- Salāsa,  BawāsÄ«r al- RahÌ£im (uterine polyps), Qurūḥ al-Rahim (uterine ulcer), Nawāṣīr(fissure) and Saraṭān -e-unq al-Rahim wa Rahim (carcinoma of cervix and uterus) etc. which leads to weakening of uterine vessels and causes vasodilation.

The etiology of Heavy menstrual bleeding includes hormonal, mechanical, and clotting abnormalities. Hormonal causes include: anovulation, hypothyroidism, Mechanical causes include, endometriosis, endometritis and carcinoma. Clotting abnormalities include: vitamin K deficiency and circulating inhibitors of coagulation. HMB can be associated with fibroids, endometriosis, adenomyosis, cervical or endometrial malignance, intrauterine devices or pelvic infections.  Sometimes it can be caused by factors in relation to hypothyroidism or bleeding disorders. Women with Heavy bleeding are at higher risk for serious medical consequences. These women are likely to develop iron-deficiency anemia as a result of their blood loss. Excessive blood loss can cause anemia, tiredness, indigestion, decreased appetite, edema and pica.

After reviewing the literature Safūf Ḥābis consisting -Sange Jarahat, Mazu Sabz, Kaat Safaid and Maeen has been selected to conduct a clinical trial. As these ingredients are having the properties of Habis (styptic), Qabiz (astringent), Muhallil Auram (anti Inflammatory) etc.

Apart from oral treatment application of Ḥijāma bilā Sharṭ (Dry Cupping) has been selected to validate and compare the efficacy of Safūf Ḥābis. Ḥijāma bilā Sharṭ is a type of regimental therapy that is used in reducing menstrual blood flow in Kathrat-i-Hayd, which is non-invasive procedure and has no potential for drug. Large cups should be placed below the breast as vessel from the uterus to the breast reach here and get absorbed due to its special connection (Mushārakat).

          Various tools have been used for the assessment of blood loss. A Pictorial Blood -loss Assessment Chart (PBAC) is a practical and objective method that has high sensitivity and specificity when more than 100 score is accepted. For Quality-of-life Menorrhagia Questionnaire (MQ) is used.

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

  • Women both married and unmarried between the age group of 18- 45yrs Women having regular cycles with increase in amount, duration of flow more than 7days or both Patients with pelvic pathology like Uterine fibroid less than 3cms (single or multiple) and Adenomyosis PBAC score more than 100.

排除标准

  • Patients with Hb less than 7 gm Patients with uncontrolled Diabetes mellitus RBS more than 200mgdl uncontrolled Hypertension BP more than 140/90mmHg Patients with Blood dyscrasias and Malignancy Patients on OCPs and other hormonal therapy.

结局指标

主要结局

Change in Pictorial Blood loss Assessment Chart PBAC

时间窗: Before and after menstruation for 3 months | One follow up in subsequent cycle

次要结局

  • Change in Menorrhagia Questionnaire scale for quality of life(Change 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 SABA ANJUM QUADRI

Government Unani Medical College and Hospital

研究点 (1)

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