Development of a Traditional Chinese Aromatic Sachet Compound for Primary Dysmenorrhea in University Students: A Three‑Round Delphi Consensus Study

Abstract

Background: Primary dysmenorrhea is highly prevalent among university women and negatively affects quality of life, study performance, and mental health. While NSAIDs are effective, adverse effects and recurrence motivate interest in noninvasive complementary approaches. Aromatherapy and traditional Chinese aromatic therapies show promise but suffer from heterogeneous formulations and limited standardization.

Objective: To establish an expert consensus on a standardized, pattern-specific traditional Chinese medicinal (TCM) aromatic sachet compound specifically for university students with cold coagulation and blood stasis type dysmenorrhea.

Methods: A formal three‑round Delphi study was conducted with 15 senior TCM clinicians in Guangzhou (Class III Grade A hospitals). An initial herb list and dosage ranges were generated from a structured literature review and TCM pattern rationale. Experts rated each herb’s agreement (5‑point Likert) and recommended dosage; rounds iteratively refined the list with controlled feedback. Decision criteria were mean agreement ≥ 4.0and coefficient of variation ≤ 0.25; coordination was assessed by Kendall’s W withp < 0.05. Expert authority was quantified by Cr = (Ca + Cs)/2, where Ca is the judgment basis coefficient and Cs familiarity. We also updated the evidence base via recent high‑indexed literature (2017–2025) on aromatherapy/TCM for dysmenorrhea.

Results: Across three rounds, 100% questionnaires were validly returned. Round‑level authority was high (e.g., Ca 0.95–0.97; Cs 0.70–0.81; Cr0.82–0.89). Expert coordination was statistically significant: Kendall’s W 0.125, 0.451, and 0.278, all p < 0.05. The final consensus yielded a 13‑herb aromatic sachet compound tailored to cold coagulation and blood stasis pattern: Bai Zhi (5 g), Ding Xiang (5 g), Ai Ye (5 g), Xiao Hui Xiang (5 g), Shan Nai (5 g), Rou Gui (10 g), Dang Gui (10 g), Chuanxiong (10 g), Xiang Fu (10 g), Mu Xiang (10 g), Mei Gui Hua (15 g), Gui Hua (15 g), Su He Xiang (0.1 g), total 105.1 g per sachet. The formulation integrates aromatic warm‑through (温通), transform dampness (化湿), and open‑the‑orifices (开窍) categories to warm channels, move blood, regulate qi, soothe mood, and mitigate gastrointestinal discomfort during menses.

Conclusion: The Delphi process produced a scientifically grounded, pattern‑specific, and practical TCM aromatic sachet formula with strong expert consensus and authority. Standardization of components and dosing addresses prior heterogeneity in aromatic interventions. The resulting standardized formula provides a robust foundation for future clinical trials to evaluate its efficacy and safety as a noninvasive modality for university students.