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临床试验/CTRI/2024/07/070202
CTRI/2024/07/070202尚未招募2 期

Clinical Study of Jawarish Qurtum and Arq e Badiyan in cases of Usr e Tams Ibtedayee primary dysmenorrhea A randomized single blind standard controlled Trial

Faiza Furqan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月20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
decrease in VAS and VMSS scores for pain intensity

研究概览

简要总结

Dysmenorrhea is a painful menstruation of sufficient magnitude so as to incapacitate day today activity .It is painful and cramping sensation in the lower abdomen often accompanied by biological symptoms such as fatigue  and dizziness occurring just before or during the menses. The incidence of primary dysmenorrhea of sufficient magnitude with incapacitation is about 15-20% . It is  a  very common complaint, experienced by 45-95% of women of reproductive age group. Dysmenorrhea is of two types: Primary dysmenorrhoea (Usr-e-Tams Ibtedayee) is a common gynecological complain refers to the occurrence of painful menstrual cramps of uterine origin during menstruation in the absence of an identifiable pathological lesion. Primary dysmenorrhea usually appears within 1-2 years of menarche, when ovulatory cycles are established. The disorder affects the younger women but may persist into the 40s.It affects more than 50% of post pubescent women in the age groups of 18-25 years. It is common in adolescent and characterized by spasmodic pain beginning with onset of menstruation and lasting 12-24 hrs. In classical  unani literature,  usr-e-Tams  has  been described as dard al-rahim or auja’-e- rahem. The pain usually occurs in the  uterus  and  spreads  to  the surrounding  areas.  It has  been  mentioned  that  any obstruction to the  flow of  menstrual blood alters the temperament  (sū’-i-mizāj)  resulting  in  difficult  orpainful  menstruation, so the drugs prescribed for the treatment of Usr e tams should be possessing the properties of muhallil, mudir e haiz, musakkin awjāh, mufattit sudad. a pharmacopoeial unani formulation Jawarish Qurtum and Arq e Bad**iyan is selected to study in patients of Usre Tams Ibtedayee. It contains 6 ingredients viz Maghz-e-Qurtum(Carthamus tinctorious) 24gm, Maghz-e-Badam Shireen(Prunus amygdalus) 24gm, Anisoon(Pimpinella anisum L.) 12gm, Bisfayej(Polypodium vulgareL.) 12gm, Asal 100gm, Mastagi(Pistacia lentiscus Linn.) 24gm. Araq e Badiyan(Feoniculum vulgare*)* also having the property of mudir e bol and digestive.

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

入选标准

  • Patients of age group 12 35 years Patients with regular painful menstruation maybe associated with one or more symptoms like Nausea vomiting diarrhea fatigue Patients with regular and irregular menstrual cycle Patients strictly with primary dysmenorrhea Patients willing to take part in the study.

排除标准

  • Patients of age less than 12 and more than 35 years hormonal and metabolic disorders any organic pelvic pathology sensitivity to NSAID Any systemic diseases like hypertension diabetes mellitus and sexually transmitted disease Patients with irregular cycle and flow Patients with secondary dysmenorrhea Lactating women If the subject not willing to continue.

结局指标

主要结局

decrease in VAS and VMSS scores for pain intensity

时间窗: 3 consecutive menstrual cycle

次要结局

  • improvement in the quality of life determined by SF 36 health survey questionnaire reduction in the duration of pain associated systemic symptoms and PBLAC score for menstrual blood loss(3 consecutive menstrual cycle)

研究者

发起方
Faiza Furqan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Faiza Furqan

Ajmal Khan Tibbiya College AMU Aligarh

研究点 (1)

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