TVVP is a Single-Arm Clinical Trial Evaluating Analgesic Efficacy of Trailokya Vijaya Vati Plus (Formulation Femme) in Dysmenorrhea
Lead Investigator
Dr. Rammanohar Puthiyedath, Research Director, Amrita School of Ayurveda, Amrita University, Amritapuri Campus, India
rammanohar@ay.amrita.edu
+91 6238032945
Principal Investigator
Dr. Sushma Naranappa Salethoor, Associate Professor, Tantra & Research Officer, Amrita School of Ayurveda, Amrita University, Amritapuri Campus, India
sushma@ay.amrita.edu
+91 8589063046
Co-PI
Dr. Shyamasundaran K, Assistant Professor, Department of Kriya Sharir & Research Officer, Amrita Centre for Advanced Research in Ayurveda, Amrita School of Ayurveda, Amrita University, Amritapuri Campus, India
shyamasundarank@ay.amrita.edu
+91 8277291906
Introduction
Medical cannabis continues to emerge as a transformative option in pain management, demonstrating significant improvements in pain relief, functionality, and quality of life. Formulation Femme was meticulously crafted to include less than 1 mg of THC per dose, ensuring it is non-psychotropic and suitable for long-term use, especially for first-time users.
This study was designed to establish the foundational safety and efficacy data for Formulation Femme while addressing broader regulatory and societal challenges surrounding cannabis-based therapies.
Methods
Study Design
From a screened cohort of 300 individuals, 27 participants were enrolled, and 26 completed the trial. Dysmenorrhea severity was assessed using two validated tools: the WaLIDD (Weighted Assessment of Lower Abdominal Pain, Impact on Daily Life, Dysmenorrhea, and Disability) scale and the VMSS (Verbal Multidimensional Scoring System).
Intervention
Participants initially received one tablet of Formulation Femme twice daily for three days. Following a protocol refinement, the dosage was adjusted to one tablet three times daily for four days. Data were collected at baseline, during intervention cycles, and at follow-up. Statistical analysis was conducted using the Friedman test to evaluate changes in dysmenorrhea severity over time.
Results
Participant Profile
Baseline Characteristics: Of the 27 participants, 13 had previously used NSAIDs, while 4 relied on Ayurvedic remedies for dysmenorrhea management.
WaLIDD Score Analysis
Statistically significant reductions in WaLIDD scores were observed throughout the study (χ² = 10.124, df = 4, p = 0.038), signifying consistent improvement in dysmenorrhea symptoms.
VMSS Score Analysis
Baseline: The median VMSS score was 3.00 (IQR: 2.00–3.00), indicating severe dysmenorrhea with considerable limitations on daily activities. Intervention Cycles (1–3): The median score improved to 2.00 (IQR: 2.00–2.00), corresponding to moderate dysmenorrhea with notable pain relief and enhanced functionality.
Follow-up (Cycle 4): Sustained benefits were evident as the median score remained at 2.00 (IQR: 2.00–2.00).
Analgesic Independence
During the intervention, no participants required additional analgesics.
At follow-up, 21 participants remained pain-free without medication, highlighting the lasting therapeutic benefits of Formulation Femme.
Discussion
The results of this Phase 1 trial underscore the promising potential of Formulation Femme as an effective and sustainable solution for menstrual pain management. Significant reductions in WaLIDD and VMSS scores, coupled with the persistence of analgesic effects during the medication-free follow-up phase, affirm its clinical utility and long-term benefits.
The inclusion of less than 1 mg of THC ensures a non-psychotropic profile, reducing dependency risks and broadening its suitability for diverse patient populations. Moreover, the integration of aśvagandhā root and bamboo silica with medical cannabis reflects a novel synergy between Ayurveda and modern science, offering a holistic approach to dysmenorrhea management.
Despite the small sample size and lack of a control group, this trial provides a robust foundation for planned subsequent randomized controlled studies.
Conclusion
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 interventions. Formulation Femme heralds a new era in integrative health, blending the therapeutic potential of medical cannabis with Ayurvedic wisdom to address an enduring and pervasive health challenge for women worldwide.
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