跳至主要内容
临床试验/CTRI/2024/11/077265
CTRI/2024/11/077265尚未招募2 期

Efficacy of Joshanda Chiraita and sitz bath in Usr al Tamth Tashanuji Spasmodic Dysmenorrhea A Randomized Standard Controlled Study

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

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
VAS score for pain intensity

研究概览

简要总结

Dysmenorrhea or painful menstruation is defined as a severe, painful, cramping sensation in the lower abdomen that is often accompanied by other symptoms, such as sweating, headache, nausea, vomiting and diarrhoea, that occur just before or during the menses. There are two commonly defined categories of dysmenorrhea: primary and secondary. Primary dysmenorrhea refers to pain during menses in the absence of any specific pathologic state and is characterized by recurrent, crampy, lower abdominal pain. Secondary dysmenorrhea refers to pain during menses that can be due to underlying pelvic pathology and is more common in women older than 20 years.

Primary dysmenorrhea results from excessive production of prostaglandins at the time of ovulatory menses. In the second half of an ovulatory cycle, the withdrawal of progesterone from the normally involuting corpus luteum causes the release of phospholipids, in particular omega-6 fatty acids, which, in turn, are initially converted to arachidonic acid, and then to prostaglandins. This production of prostaglandin results in increased intrauterine pressure and abnormal uterine contractions. In addition, vasoconstriction of uterine vessels results in decreased blood flow, ischemia of the uterine muscles, and increased sensitivity of pain receptors, all of which cause pelvic pain.

In Unani classical text, causes (Asbab) of dysmenorrhea is described as Sū’-i-Mizāj Mukhtalif of Rahim, Riyāḥ al -ghaleez, Ruṭūbat -i- Ghilẓ, Sudd’a-al-Rahim. Abnormal humour may cause pain either by their abnormal quality, quantity or combination of both factors. Various single drugs like chiraita, Abhal, Asarun, Sonf, Asgand, Amaltas, Annanas, Elva, Babuna, Bakain, Parshioshan, Podina, Khare khask, Hulba, Hilteet, Kalonji, Mushtar Mashi, Neem, Darchini, Qust Zanjabeel etc have been mentioned in classical Unani literature for the management of ‘Usr al- tamth .

The visual analogue scale (VAS) is a robust and accurate assessment of the intensity of chronic pain. Because of its simplicity and reliability, VAS is a widely used validated scale with a 10 cm line (0-10 defined as no pain to worst pain).

Chiraita (Swertia chirata) also known as Qasabuzzarirah in Arabic language is a popular medicinal plant. It belongs to family Gentianaceae. According to Unani literature it possesses actions like Muá¹£affÄ«-i-Dam(blood purifying agent),  Dāfi‘-i-Ḥummā  (antipyretic), Muḥallil-e-awram (anti-inflammatory*),  Mudirr-i-Bawl*  (diuretic) Mulaá¹­á¹­if  (resolvent*)  Kāsir-i-Riyāḥ   (carminative) Mudirr-i-Ḥayḍ (emmenogogue),  MuqawwÄ«-i-Kabid  (liver tonic),* Qātil-i-DÄ«dān-i-Am‘ā’ (anti helminthic), mufriz-i- laban (galactogogue).

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
12.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Both married and unmarried subjects between the age group of 12years to 35 years Subjects with regular painful menstrual cycle 28±7day Subjects with spasmodic dysmenorrhea having Visual Analogue Scale VAS Score for pain intensity more than 4.

排除标准

  • Patients with systemic illness like hypertension, diabetes mellitus and thyroid dysfunction.
  • Patient with pelvic pathology like PID, uterine fibroids, endometriosis, adenomyosis.
  • Patient on any hormonal treatment Lactating women Patients allergic to NSAID’s.

结局指标

主要结局

VAS score for pain intensity

时间窗: Every month after menstruation for 3 months | One follow up in subsequent cycle

次要结局

  • SF-12 scale for QoL(Spasmodic dysmenorrhea associated symptoms)

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 SARA MUJEER

Government Unani Medical College and Hospital

研究点 (1)

Loading locations...

相似试验

Research on painful menstruation | 临床试验