An Open-Label, Single-Arm, Single-Center Clinical Study To Evaluate The Safety And Efficacy of Bonduc Nut Capsules in Participants with Menopausal Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Menopause is a natural physiological stage in women characterized by the permanent cessation of menstruation and is often associated with vasomotor, psychological, and urogenital symptoms that can significantly impair quality of life. Although hormone replacement therapy is effective, its use is limited by safety concerns and contraindications, leading many women to seek non-hormonal alternatives. Botanical therapies used in traditional medicine systems are increasingly being explored for menopausal symptom management. Caesalpinia bonduc (Bonduc nut) has been traditionally used for women’s health and has demonstrated antioxidant, anti-inflammatory, and adaptogenic properties in preclinical studies. Piper nigrum (black pepper) contains piperine, a known bioavailability enhancer with neuromodulatory and antioxidant effects. The present study aims to clinically evaluate the safety and efficacy of Bonduc Nut capsules, a combination of Caesalpinia bonduc and Piper nigrum, in 50 women experiencing menopausal symptoms over a duration of 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Perimenopausal women between 40 to 60 years of age with a history of menopausal symptoms for at least one month within the last one year.
- •2.Presence of moderate to severe menopausal symptoms like hot flashes night sweats insomnia nervousness mood swings vaginal dryness loss of libido.
- •3.Able and willing to give written informed consent and comply with the requirements.
排除标准
- •1.Participants with a history of psychiatric illness.
- •2.Participants who had surgical menopause.
- •3.Participants suffering from major systemic illness necessitating long term drug treatment like Rheumatoid arthritis Psycho-Neuro-Endocrinal disorders 4.Participants who are undergoing hormonal replacement therapy.
- •5.Participants having major organic pathology of the reproductive system like carcinoma fibroid cyst.
- •6.Participated in another clinical drug trial within 3 months before recruitment.
- •7.Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
- •8.Participants with any kind of malignancies.
研究者
Dr Suguru Vasudha
Sri Lakshmi Super Speciality Hospital