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临床试验/CTRI/2023/07/055235
CTRI/2023/07/055235尚未招募2 期

Efficacy and safety of Asaroon in primary dysmenorrhea in comparison with mefenamic acid: A randomized double blind standard controlled trial

Luqman Unani Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Change in Severity of pain determined by VAS

研究概览

简要总结

Dysmenorrhea (Difficult menstrual flow) is one of the most prevalent gynaecological problems that affects about half of all female adolescents or college-bound females, It interferes with their daily activities. One of the most frequent menstruation symptoms worldwide among people of reproductive age is dysmenorrhea, which is underdiagnosed and undertreated. It carries a worse illness burden than any other gynaecological condition in underdeveloped nations.  Primary dysmenorrhea and secondary dysmenorrhea are the two main kinds of dysmenorrhea. Primary dysmenorrhea is described as menstrual cramping pain without any underlying pelvic pathology, and secondary dysmenorrhea is described as menstrual discomfort caused by any underlying pelvic disease. The most frequent justification for missing time at school, work, or family doctor appointments is dysmenorrhea,and it occurs in ovulatory cycles, hence it makes its appearance a few years after menarche . It is still unclear how often primary dysmenorrhea actually is. However, Goerge and Bhaduri found dysmenorrhea to be a common problem in India with the prevalence of 87.7%.  According to the WHO Data, as many as 94% of young girls aged 10-20 and 8.8% of woman aged 19-41 suffer from menstrual painPrimary dysmenorrhea can be treated with a range of pharmaceutical and non-pharmacological techniques, such as non-steroidal anti-inflammatory medications (NSAIDs) and oral contraceptives.  The effectiveness of oral contraceptives and NSAIDs is considerable, however failure rates might still range from 20% to 25%. However analgesic are not an effective solution because of the risks for decreased effectiveness and increasing dependency . Some women with primary dysmenorrhea may not tolerate or be contraindicated for this therapy.  Although there are treatments for menstruation pain, getting full relief is still challenging. Therefore, a low-toxic alternative herbal treatment is necessary . Terms used for dysmenorrhea in the Unani literature are dard-i-rahim , waja’al-rahim, or auja al-rahim and usr-i-tamth and to treat this condition, several drugs have been mentioned for oral as well as local application likebirinjasif, kharnub, bazrulbanj, zarawand, mur, irsa, habbulgaar, pudina, jawitri,tukhme karafs ,rewand khatae, amaltas  .Asaroon (Asarum europaeum L.), is one of them which can be given orally to relief dard al-rahim Numerous studies have shown that the extract of plants in the genus Asarum contains a rich complex of biologically active substances, including alkaloids, flavonoids, triterpene saponins, steroids, phlobatanin, amino acids, coumarins, higher fatty acids, polysaccharides, vitamins of group B, C, and E, essential oils, and others. Asarum (asaaroon) is currently scientifically and pharmacologically proven for its anti-inflammatory activity in animal models and are therefore can be helpful in   reduction of menstrual pain Considering this fact, it has been decided to conduct the clinical trial to evaluate the efficacy of Asaroon in patients with primary dysmenorrhoea in comparison with mefenamic acid.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • •Married and unmarried patients between 15 to 35 years of ages having regular menstrual cycles Patient diagnosed with primary dysmenorrhea Patients with Visual Analog Scale less than or equal to 4cm for at least three menstrual cycles before this study.

排除标准

  • •Pelvic disease such as fibroid adenomyosis PID endometrial polyp ovarian tumour Irregular menstrual cycles Pregnancy and lactation Systemic illness Oral contraceptives and those Wearing IUCD devices Participants with congenital anomalies of uterus.

结局指标

主要结局

Change in Severity of pain determined by VAS

时间窗: before after treatment

Change in duration of menstrual pain

时间窗: before after treatment

次要结局

  • Change in HRQoL determined by SF-12 v1 health survey questionnaire(Change in PBLAC score for menstrual blood loss)

研究者

发起方
Luqman Unani Medical College Hospital and Research Centre
申办方类型
Private medical college

研究点 (1)

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