Efficacy and safety of Asaroon in primary dysmenorrhea in comparison with mefenamic acid: A randomized double blind standard controlled trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Severity of pain determined by VAS
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Severity of pain determined by VAS
Time Frame: before after treatment
Change in duration of menstrual pain
Time Frame: before after treatment
Secondary Outcomes
- Change in HRQoL determined by SF-12 v1 health survey questionnaire(Change in PBLAC score for menstrual blood loss)
