A Randomized Comparative Clinical Study to Evaluate the Efficacy of Nashtapushpantaka Rasa and Rajahpravartini Vati in the management of Artavakshaya in Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Changes in Menstrual cycle length intermenstrual period amount and quality of bleeding.
研究概览
简要总结
The Study is a Randomized, Open label, parallel group comparative clinical study to evaluate and compare the efficacy of Nashtapushpantaka Rasa 250 mg bd and Rajahpravartini Vati 250 mg bd for 99 days in 134 patients with Artavakshaya in Polycystic Ovarian Syndrome will be conducted at one centre in India. Primary Outcomemeasure will be Changes in Menstrual cycle length, intermenstrual period, amount and quality of bleeding. In USG changes in ovarian volume and polycystic appearance of ovary and Changes in hormone levels serum FSH, LH, Ratio LH FSH, Prolactin, testosterone etc. at baseline and after 99 days.Secondary outcome measure will be Changes in hirsutism based on Ferriman Gallway score and Changes in Quality of Life using PCOS Qol Scale at baseline and after 99 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females having PCOS assessed on Rotterdam criteria -2outof3 -oligo-and or anovulation -clinical and or biochemical signs of hyperandrogenism -polycystic ovaries in USG Patient is ready to provide signed informed consent.
排除标准
- •PCOS with heavy menstrual bleeding or menorrhagia or metrorrhagia.
- •Females less than 18 yrs.
- •and more than 40 yrs.
- •Females having primary amenorrhea.
- •Females having physiological secondary amenorrhea due to lactation.
- •Females with any organic pelvic lesions like fibroid uterus, adenomyosis, PID etc.
- •Females with hypo and hyper thyroidism.
- •Patients using oral contraceptive pills.
结局指标
主要结局
Changes in Menstrual cycle length intermenstrual period amount and quality of bleeding.
时间窗: baseline and after 99 days
In USG changes in ovarian volume and polycystic appearance of ovary.
时间窗: baseline and after 99 days
Changes in hormone levels serum FSH LH LH FSH ratio Prolactin testosterone etc
时间窗: baseline and after 99 days
次要结局
- Changes in hirsutism based on Ferriman- Gallway score.(Changes in Quality of Life using PCOS-Qol Scale.)