A Prospective, Open-Label, Single-Arm, Multiple-Center Clinical Study to Evaluate the Safety and Efficacy of PMS tablets in Subjects with Menopausal symptoms
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
研究概览
简要总结
Introduction: Menopause is the natural cessation of menstruation, usually occurring between 45 and 55 years, with Indian women reported to experience menopause at a slightly younger age (mean ~46 years) compared with Western populations. Menopause is often accompanied with symptoms like hot flashes, night sweats, mood changes, sleep problems, and vaginal dryness. These symptoms can significantly affect a woman’s quality of life. While hormone replacement therapy (HRT) can help, its use is limited due to safety concerns. Many women seek safer alternatives, including Ayurvedic medicines.
In Ayurveda, menopausal symptoms are described as Rajonivritti, linked to Vata and Pitta imbalances. Herbal ingredients used in Ayurvedic formulations—such as Shatavari, Ashoka, Bala, and Lodhra—may help restore balance, reduce symptoms, and improve well-being. PMS Tablets are a standardized Ayurvedic formulation designed to relieve multiple menopausal symptoms.
Purpose of the Study: This study aims to evaluate the safety and effectiveness of PMS Tablets in women with menopausal symptoms. It will assess improvements in symptoms and quality of life using validated tools (MRS, UQOL, MENQOL) and monitor safety through laboratory tests and adverse event reporting. The study intends to provide clinical evidence for PMS Tablets as a safe, effective, and holistic alternative to conventional therapies for menopause management.
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
- •Females aged 40 to 60 years.
- •Perimenopausal or postmenopausal women with a history of menopausal symptoms for at least 1 month within the last 12 months.
- •Presence of moderate-to-severe menopausal symptoms defined as MRS score 9-15 is moderate and MRS score greater than or equal to 16 is severe.
- •Willing and able to provide written informed consent.
- •Willing to comply with study procedures and visit schedule.
排除标准
- •History of psychiatric illness or alcohol dependence.
- •History of surgical menopause.
- •Current or past history of major systemic illness requiring long-term drug treatment (e.g., rheumatoid arthritis, psycho-neuro-endocrine disorders).
- •Current use of hormonal replacement therapy (HRT).
- •Known major organic pathology of the reproductive system (e.g., carcinoma, fibroids, ovarian cysts).
- •Use of any investigational drug within 1 month prior to randomization.
- •Known or suspected malignancy of any type.
- •Pregnant or lactating women.
- •Clinically significant abnormalities in Baseline laboratory values, including:.
- •Liver function-AST or ALT greater than 2.0 × ULN, total bilirubin greater than 1.5 × ULN (or greater than 2.0 × ULN unless known Gilbert’s syndrome).
- •Renal function-eGFR less than 60 mL per min per 1.73 m-square or creatinine above normal range.
- •Thyroid profile-TSH outside reference range or uncontrolled thyroid disease.
- •Lipid profile-Triglycerides greater than or equal to 500 mg per dL or LDL-C greater than or equal to 190 mg per dL.
- •Abnormal vitals at Baseline-.
- •Systolic BP greater than or equal to 160 mmHg or Diastolic BP greater than or equal to 100 mmHg.
- •Resting heart rate outside 50–100 bpm unless deemed clinically acceptable by the Investigator.
- •Body temperature greater than or equal to 38.0 degree celsius.
- •Any acute illness or clinically significant abnormality on physical examination at Baseline, in the Investigator’s judgment.
- •Any other condition that, in the Investigator’s opinion, may interfere with study compliance, safety, or data interpretation.
研究者
Ms Arpita Malgi
Samahitha Research Solutions