Comparative Clinical Assessment of Two Polyherbal Formulations in Menstrual Health – A Proof of Concept
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- • Re-establishes cyclical bleeding.
研究概览
简要总结
Current study is a comparative clinical study of two polyherbal formulations for menstrual health. Study will be conducted under supervision of Ayurvedic and Allopathic Doctors as investigator and co-investigators in subjects between 19 to 45 years of age and who will be followed up at monthly intervals. results of the study will be assessed basis regularization of menstruation, improvement in quality of life and PMS from baseline to end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Provision of signed and dated informed consent prior to any study-specific procedures.
- •Healthy females in the age group of 19-45 years with a history of psychological or somatic signs and symptoms of PMS
- •Females with irregularity menstrual cycles (based on history)
- •Not on any hormonal therapy during and one month prior to the trial.
- •Willing to practice birth control methods other than hormonal contraception (barrier/condoms) during study period (as applicable)
- •Willing to follow study related procedures.
排除标准
- •Subjects not willing to sign ICD.
- •Menopausal or peri-menopausal based on history
- •Currently pregnant or breastfeeding
- •Planning pregnancy in next 3-4 months
- •Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial.
- •Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc)
- •Gynaecological conditions like genital tuberculosis, history of any malignancy or organic lesions like polyps, fibroids, endometriosis etc.
- •Prescence of chronic systemic conditions like endocrinal disorder like Cushing’s syndrome, hypertension, heart diseases, diabetes, hepatic disease, renal disease, or any psychiatric condition (medical history)
- •Subjects who in Investigators’ opinion will not be able to follow study related procedures.
结局指标
主要结局
• Re-establishes cyclical bleeding.
时间窗: 30, 60, 90 days
• Controls excess bleeding occurring in the menstrual cycle.
时间窗: 30, 60, 90 days
• Relieves from backache, pelvic pain, abdominal cramps.
时间窗: 30, 60, 90 days
• Controls leucorrhoea
时间窗: 30, 60, 90 days
Improvement basis change in CGI scale
时间窗: 30, 60, 90 days
• Modification in Quality of Life (QoL) – includes fatigue, Mood swing, hot flushes on sole, restlessness, anxiety, irritability, bloating, food cravings, nausea, vomiting, diarrhoea/ constipation, headaches /joint pains etc (assessed by psychologist as per Annexure 2)
时间窗: 30, 60, 90 days
次要结局
- • Improvement in PCV, and Hb%, glowing skin.(• Regularization of Menstrual Irregularities (oligomenorrhea, menorrhagia, Polymenorrhea, hypomenorrhea – DUB))
研究者
Prof Dr Pradip Kumar Panda
Sri Sri College of Ayurvedic Science and Research Hospital