During the menstruation cycle, some females may experience pain also known as dysmenorrhoea with or without abdominal cramps, nausea, fatigue, headache, backache, general discomfort and emotional and psychological effects symptoms (1).This cyclic pain with the origin of uterus muscles which directly linked to menstruation but with no detectable pelvic pathology (2. It is commonly known as menstrual cramps, and has recurrent pain around the lower abdomen occurring immediately before or during menstruation in the absence of underlying conditions (3). Primary dysmenorrhea is one of the most common gynecologic disorders which occur in fifty to ninety percent of girls and women of reproductive age (4). Its prevalence according to the different studies in Iran has been reported near eighty percent (5). Primary dysmenorrhea is a common cause of absenteeism from work, education, or physician, which may lead to decreased efficacy of occupation and education (4) .Although it is not life threatening, it could have adverse effects on daily routine activity and quality of life especially in adolescents, if not properly managed (6).The most common treatments for primary dysmenorrhea are oral contraceptive capsules (OCPs) and none-steroidal anti-inflammatory medications (NSAIDs). By preventing prostaglandin (PG) production and lowering vasopressin release, NSAIDs lower myometrial activity and the chronic side effects of NSAIDs include liver, renal, and digestive system issues. Contraceptive capsules reduce the volume of menstrual fluid and the amount of prostaglandin (PG) generated by suppressing ovulation and thinned endometrial lining, which lessens discomfort related to uterine contractions. Herbal medicine has an important role in women health (7). There are a number of herbal remedies for treatment of primary dysmenorrhea (8). In a study by with the aim to examine the self- management practice for primary dysmenorrhea among a group of female undergraduate students, result indicated that around above of half percentage of participants used analgesics for managing menstrual pain, which paracetamol was the most commonly used analgesics (9). Regarding the effects of chemical drugs and the usage of herbal medicine, as well as alternative and complementary therapies in treatment of diseases, many studies have been drawn to this area (10). Prescribing natural substances with therapeutic nature has been used since ancient times and recently women are intent to alternatives for the synthetic medicines since medical treatments for the dysmenorrhea has much risk rate with intolerable effects on the them (11). Also these treatments would be used as alternatives to the NSAIDs and other hormonal treatments, with not only lower side effects, but also with higher patients' acceptance (12), Besides women can have access to herbal remedies more comfortably to decrease dysmenorrhea symptoms (13). Recent evaluations the efficacy of herbal extracts in primary dysmenorrhea have shown the beneficial effects of  them on pain, inflammation, and dysmenorrhea which was significant compared mefenamic acid, paracetamol and acetaminophen 14. Now a days there are many attempts for alternatives traditional or herbal treatments against primary dysmenorrhea and many evidences have reported that use of natural herbs may play an important role in the case of menstrual disorders such as primary dysmenorrhea (15). Ginger is an indigenous perennial climbing plant found in South Asian countries (16). Gingerol, shogaol, paradol, zingerones, and gingerdione are components of ginger and they have anti-inflammatory pharmacological acts to inhibit of prostaglandins and leukotriene biosynthesis and synthesis of inflammatory cytokines at the site of inflammation (17). Very few systematic reviews have examined the effectiveness of ginger for pain duration and its severity among females with primary dysmenorrhea and its analgesic effectiveness with paracetamol and mefenamic acid with the lower side-effects for primary dysmenorrhoea (18). Lavender species are common in herb gardens for their fragrant leaves and attractive flowers (19). It is sometimes also used to flavor beverages and sweets and has a number of applications in herbal medicine (20). Linalool and linalyl acetate are among the effective compounds of lavender oil with positive and significant effects on the central nervous systems. Moreover, their analgesic, anti-inflammatory, and sedative effects have been proven in various studies (21). Lavender derived compounds have anti-inflammatory and analgesic effects especially in reducing the symptoms of dysmenorrhea and mild to moderate depression (22). (23) showed that the lavender essential oil can be used as a reference in alternative and complementary medicine for the management and treatment of primary dysmenorrhea. Because of primary dysmenorrhea treatments by chemical drug and their side effects such as liver and kidney damage, recently researcher have been focused and preferred to use of herbal remedies because of lower side effects of woman health. About the prevalence of the primary dysmenorrhea and the side effects of the chemical treatments and because of lack of similar studies in this field this study was aimed to determine the effects of oral ginger and lavender essential oil capsules intervention in comparison with mefenamic acid and paracetamol on the intensity of primary menstrual pain in teenage students.

Study Procedures

A randomized, single-blind controlled semi experimental trial was conducted among 160 single teenage students aged 15 to 19 years who study at Indian high school located in Bangalore and suffered from primary dysmenorrhea in the time frame December 30, 2021 to October 30, 2022. The participants had no underlying medical or psychological disorder.The eligible participants fulfilled the written informed consent form and the self-completed questionnaire and the scale form and were visited physically by a licensed gynecologist before trial intervention.

Experimental design

The extent and severity of dysmenorrhea pain was evaluated using the Cox menstrual symptom scale (without pain ≤ 0, for ≥ 0.5 h ≤ 1, for 0.5 – 1 h ≤ 2, for several hours ≤ 3 and several days ≤ 4). Each participant was randomly assigned to ginger and lavender essential oil capsules or paracetamol and mefenamic acid, ending with 40 participants in each group equally. The control and experimental trial groups received 250 mg of paracetamol and mefenamic acid and also herbal capsules, orally four times (each 6 hours) daily, until the pain grade reached one or less. The trial participants were permitted to take another drug that they usually took for their pain relief, in addition to the allocated treatment in case of continued pain. At the end of the trial period, mentioned participants were excluded in data analysis. Changes in the grade and the duration of the pain of each participant were compared at the first and second months in all groups. Two sectioned questionnaire was used to collect the data. The first section included the demographic data, menstrual history, smoking, diet, exercise and past medical and reproductive history that was completed before the intervention of the trial. The second section was designed to cover the grade and duration of pain and the accompanying symptoms was completed during the two months follow up of the trail. The primary outcome was the intensity of menstrual pain, which was determined using the verbal multi-dimensional scoring system described by (Andersch and Milsom 1982). It has four grade including grade 0: menstruation is not painful and daily activity is unaffected, grade 1: menstruation is painful but seldom inhibits normal activity, analgesics are seldom required; mild pain, grade 2: daily activity is affected, analgesics required and give sufficient relief so that absence from school is unusual; moderate pain and grade 3: activity clearly inhibited, poor effect of analgesics, vegetative symptoms such as headache, fatigue, vomiting, and diarrhea.

Statistical analysis

In the current study the obtained data was analyzed using α =5% and absolute error equal to 0.25 for correlation between medication and pain with acceptable absolute precision formula and P-value of 0.05 was considered statistically significant. Randomization was determined on a 1:1 basis using random number tables.

The statistical comparisons were determined using the Mann-Whitney Utest, unpaired t-test, and within-group comparisons were analyzed by paired t test or Wilcox on.

Ethical evaluation

All teenagers in the study were voluntary and the participants were free to withdraw from the study whenever they wished. An informed consent was obtained from all participants before enrolment into the study.

As result presented in table 1, the mean age was 17.5±1.2 and 17.4±1.4 years in cinnamon and fennel essential oil capsules, mefenamic acid and paracetamol groups, respectively. There was no significant difference was observed for the matched characteristics studied between the treated groups.

Table 1. Characteristics comparison between trial groups

*SD = Standard deviations; n.s=**no significant.

Data  presented form table 2 also showed that the chemical medication by mefenamic acid and paracetamol was the most common method used by the participants in all groups as the pain relief procedure before interventions applied by the current clinical trial. The subjects were followed up at least for two sequential periodic cycles. The pain grades were similar in four groups before intervention. About 3 h after the intervention at the first day of menstruation the mean pain grade amongst ginger and lavender group was decreased, while in paracetamol group, respectively, using the described given dose as shown in table 3.

Table2. Pain relief comparison between different trial groups before intervention

The comparisons of the pain duration between the different groups at the first month of the intervention are shown in Table 3.

Table 3. Pain duration comparison of between trial groups at various time points following intervention.

There was no statistically significant decrease in pain duration for the females who received paracetamol and mefnamic acid compared to those who used oral ginger and lavender capsules. Also, there was no significant difference in pain grade between the groups at the second month of intervention. Pain duration at the second month of trial was similar between the all groups. Furthermore, the duration of menstrual flow was similar between the two groups before intervention, while chemical drugs reduced the duration of menstruation compared to the herbal capsules at the first and the second month of the intervention. The present results suggested that the both oral herbal capsules and chemical drug group had beneficial and equality reduced the grade and the duration of menstrual pain. The effects of herbal pain killers may be attributed to their action as antispasmodic and anti-prostaglandin synthesis. (24) indicated that there was no significant statistical difference between the amount and the intensity of menstrual bleeding in the herbal intervention group before and after the intervention. Some researcher mentioned that  use of mefenamic acid and vitamin E  alone or together  had some beneficial act on pain duration  and severity of primary dysmenorrhea 25

The result of (26) study showed that the use of the ginger-lavender combination capsule can relieve the pain caused by primary dysmenorrhea and reduce the duration and severity of pain. One of the characteristics of inflammation is increased oxidation of arachidonic acid and the production of prostaglandins and leukotrienes and some researchers have shown that ginger has components with anti-inflammatory properties and inhibitory effects on prostaglandin biosynthesis and cyclooxygenases 1 and 2 and it is also inhibits the production of leukotriene by inhibiting 5 lipoxygenase and can relief the pain and severity of primary dysmenorrhea (27).Terry et al., 2011 concluded that there is preliminary support of the efficacy of ginger on pain conditions such as dysmenorrhea are in consistent with current study result. (28) showed that there was a significant difference in average pain severity between lavender treatment and control groups after intervention. However, students in the treatment group reported significantly less pain severity 2 months after intervention. (29) concluded that lavender inhalation can decrease primary dysmenorrhea. They also observed that the effectiveness of lavender inhalation as an inexpensive therapy without evidence of adverse event supports the interest for potential application of this therapy. Similarly (30) compared the pain in the first and second days just in one cycle of menstruation, in which the mean pain intensity in the group of aromatherapy with lavender was significantly lower than the group undergoing massaging with almond oil and the group without the intervention

The results of this study may conclude that ginger and Lavender pill intervention as novel herbal pain killer represent an effective treatment for the menstrual pain with no important side effects. The current studies showed that ginger and Lavender remedy intervention have good efficiency for relieving the severity of primary dysmenorrhea pain also. Therefore, healthcare providers should consider them as treatment for young females with primary dysmenorrhea. The future studies are recommended to test the feasibility and effectiveness of differ dosage therapy in large segments of population for more explanation.

Conflict of interests

There is no known conflict of interests associated with this paper

Financial supports

There has been no significant financial support for this work that could have influenced its outcome

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