Efficacy evaluation of Unani formulation in pain during menstrual cycle.

Phase 2

Not yet recruiting

Conditions: Primary dysmenorrhea,

Registration Number: CTRI/2023/07/055235

Lead Sponsor: Luqman Unani Medical College Hospital and Research Centre

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* , *wajaâ€™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 like*birinjasif, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Severity of pain determined by VAS	before after treatment
Change in duration of menstrual pain	before after treatment

Secondary Outcome Measures

Name	Time	Method
Change in HRQoL determined by SF-12 v1 health survey questionnaire	Change in PBLAC score for menstrual blood loss

Trial Locations

Locations (1): Luqman Unani Medical College Hospital and Research Centre
🇮🇳
Bijapur, KARNATAKA, India
Luqman Unani Medical College Hospital and Research Centre
🇮🇳Bijapur, KARNATAKA, India
Dr Hina Bano Nurullah
Principal investigator
7218871491
drhinanurullah@gmail.com