Safety and Efficacy of Novel Poly-Herbal Formulations in Alleviating Psychological and Physical Symptoms of Menstrual Disorders: A Randomized Clinical Study

Mohanty B, Panda PK, Mishra B*, Satpathy B, Reddy YS, Mishra S, Gupta G and Rajesh AS

Department of Gynecology and Obstetrics, Shishu Bhawan (Branch of SCB Medical College), Cuttack, India.
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack, India.
Dabur Research and Development Centre, Healthcare Division, Ghaziabad, Uttar Pradesh, India
Independent Consultant, Bengaluru, India

^*Correspondance to: Mishra B 

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Abstract:

Menstruation is a cyclic process right from 1st menstrual cycle of pubertal girl to the age of menopause. Recently, menstrual irregularities and associated psychological, physiological effects are rising among women. Hormonal therapy is a choice but have their own limitations. Natural botanical-based approaches were cited in ancient ayurvedic literature, which needs to prove their scientific efficacy. Current study, aimed to evaluate poly-herbal formulations (DHP Syrup: DRDC/2023/042 and DHP Tablet: 043 and DSS syrup: DRDC/2023/046) efficacy using in vitro system i.e., SKOV3 (human ovarian cancer cells). Antioxidant activity assessed by glutathione-peroxidase (GSH-Px) and catalase levels, whereas anti-inflammatory potential through TNF-α levels. Pilot clinical study was carried out in two groups i.e., Group 1- DHP syrup & tablet and Group 2 - DSS syrup for 3 consecutive menstrual cycles. Menstrual cycle associated signs and symptoms for psychological, physical and menstrual process were assessed. The in vitro data suggests antioxidant and anti-inflammatory potential of test compounds (DHP syrup & tablet and DSS syrup). Both groups have shown significant improvement in signs and symptoms associated with menstrual cycle at the end of treatment compared to baseline. Whereas, ‘no significant difference’ was noted between groups. Neither Adverse Events (AEs) nor Severe Adverse Events (SAEs) were reported by the participants of both groups. Results conclude that the tested herbal formulations have efficacy in countering menstrual associated psychological & physical signs and symptoms. Further, test formulation efficacy can be attributed to quenching of oxidative stress through its antioxidant potential and modulating the TNF-α levels, which are key in pathophysiological process.

Keywords:

Menstrual cycle; Psychological signs and symptoms; Antioxidant potential; Anti-inflammatory activity

Cite the Article:

Mohanty B, Panda PK, Mishra B, Satpathy B, Reddy YS, Mishra S, et al. Safety and Efficacy of Novel Poly- Herbal Formulations in Alleviating Psychological and Physical Symptoms of Menstrual Disorders: A Randomized Clinical Study. Clin Case Rep Int. 2026; 10: 1767..