New preliminary research highlights the potential of Ayurvedic medicine combined with medical cannabis as an alternative treatment for menstrual cramps.
Results from a Phase 1 clinical trial have found ‘strong preliminary evidence’ to support the safety and efficacy of a new patent-pending formulation in the management of menstrual cramps (also known as Dysmenorrhea).
The study, conducted at the Amrita School of Ayurveda in India, aimed to establish the safety and efficacy of Formulation Femme, an Ayurvedic formulation combining medical cannabis (containing less than 1mg of THC), bamboo silica, and aśvagandhā root, developed by Indian healthcare company, Hemp Street.
Ayurveda is an ancient alternative form of medicine, originating in India, that uses herbal remedies to manage illness.
Researchers screened a cohort of 300 individuals, with 27 participants enrolled, and 26 completing the trial. Half of these had previously used NSAIDs — the most common treatment choice for menstrual cramps— while four relied on Ayurvedic remedies.
Participants initially received one tablet of the formulation twice daily for three days, with the dose later adjusted to one tablet three times daily for four days.
Data was collected at baseline, throughout the intervention cycles and at follow-up using the WaLIDD (Weighted Assessment of Lower Abdominal Pain, Impact on Daily Life, Dysmenorrhea, and Disability) scale and the VMSS (Verbal Multidimensional Scoring System).
‘Consistent improvement’ including ‘notable pain relief’
At the beginning of the study, participants experienced severe dysmenorrhea which had a ‘considerable impact’ on their ability to carry out daily activities.
After conducting a statistical analysis, the research team found ‘statistically significant’ reductions in WaLIDD and VMSS scores, signifying ‘consistent improvement’ in dysmenorrhea symptoms, including ‘notable pain relief and enhanced functionality’.
During the trial none of the participants required additional analgesics and in the follow-up assessment, 21 participants remained pain-free without medication.
Writing in the paper’s discussion, the researchers say these results underscore the ‘promising potential’ of the formulation as an ‘effective and sustainable solution’ for menstrual pain management.
A ‘robust foundation’ for further research
The findings, shared with Cannabis Health ahead of publication, are limited by the study’s small sample size and the lack of a control group. However, the authors believe the work provides a ‘robust foundation’ for planned further randomised controlled trials.
The authors conclude: “This Phase 1 trial provides strong preliminary evidence supporting the safety, efficacy, and acceptability of Formulation Femme in managing dysmenorrhea. The formulation represents a meaningful advancement in menstrual health care, offering a non-psychotropic, Ayurvedic-based alternative to conventional therapies.
“Future research should focus on larger, controlled trials to further validate these findings and explore complementary lifestyle intervention.”
Cannabinoids and menstrual health
The new findings build on previous studies which have suggested that cannabis-based products could have promising potential for alleviating menstrual-related symptoms.
A study published in Nature Partner Journal: Women’s Health last year examined the impact of a high-CBD suppository on menstrual-related pain and discomfort.
Results showed that the CBD group demonstrated ‘significantly reduced frequency and severity of menstrual-related symptoms’, as well as ‘impact of symptoms on daily functioning’ and the need for other analgesics, compared to those using traditional painkillers.
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Author: Sarah Sinclair
