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临床试验/CTRI/2025/01/079044
CTRI/2025/01/079044尚未招募2 期

Efficacy of Asgand in Premenstrual syndrome: A Self Controlled Study

Government Unani Medical College & Hospital Bangalore-5600791 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年1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
37
试验地点
1
主要终点
Reduction in PMTS Score

研究概览

简要总结

Premenstrual Syndrome (PMS) is a common health problem in women, which includes series of psychological and physical symptoms experienced 7 to 14 days before the onset of menses.The American College of Obstetricians and Gynaecologists (ACOG) defined PMS as a clinical condition characterized by the cyclic presence of physical and emotional symptoms unrelated to any organic disease that appear during the 5 days before menses in each of the three prior menstrual cycles and disappear within 4 days of the onset of menses, without recurrence until at least cycle day 13. It is estimated that 85%-90% women of childbearing age may experience physical and mental symptoms before the onset of cycle. According to Unani physicians, imtelayi kaifiyat present in the premenstrual phase causes a variety of symptoms like anxiety, tension, headache, irritability, decreased concentration, depression, mood swings, insomnia, anorexia, palpitation, pelvic pain, backache, numbness in hands and legs. It is well documented that a surge of Akhlat muharrika (hormones) is responsible for the accumulation of body fluid in tissue spaces during the premenstrual period and this theory corresponds to the concept of Ibne Sina.According to conventional systems, causes of PMS are not fully known and there is no cure for PMS, its symptoms can be successfully managed by several medicines. The management of PMS ranges from non-pharmacological treatment which includes Dietary supplementation, Cognitive behavioural therapy, Life style changes and pharmacological treatment like antidepressants, hormonal treatment and symptomatic treatment. As Ibne Sina mentioned that treatment should be based on cause, if the cause is heat (hiddat) and dominance of bile it is best treated by evacuation (istefragh) of bile especially by shahtra and halela and if retention of fluid is the reason, then it is excreted through the skin by using drugs such as samaghe arabi and kateera, and if the cause is the weakness of uterus, then astringent with uterine tonics is advised. As Asgand has the actions of alterative, aphrodisiac, deobstruent, diuretic, narcotic, sedative, uterine tonic, analgesic etc. it has been decided to conduct a clinical study to evaluate the efficacy of Asgand on scientific parameters in patients with PMS.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Both married and unmarried patients in the age group of 18 to 35 years with regular menstrual cycle between 21 to 35 days presenting with symptoms of PMS as per ACOG diagnostic criteria and PMTS scale score more than 7.

排除标准

  • Patients with Systemic illnesses DM, HTN, TD Organic pelvic pathology, Patient on hormonal therapy in last 3 months , H/O Psychological disorders , Pregnant and Lactating women.

结局指标

主要结局

Reduction in PMTS Score

时间窗: During treatment 5th day of every cycle for 3 cycles | Post treatment After 1 month

次要结局

  • Improvement in SF 12 scale for QoL(During treatment 5th day of every cycle for 3 cycles)

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 Shafiya Roohi

Government Unani Medical College and Hospital

研究点 (1)

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