Efficacy of Rajahpravartini Vati in Adolescent and Young Females with Primary Dysmenorrhoea – Double-blind Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in severity of primary dysmenorrhoea assessed by change in ‘WaLIDD’ score.
研究概览
简要总结
Study Title: Efficacy of Rajahpravartini Vati in Adolescent and Young Females with Primary Dysmenorrhoea – Double-blind Randomized Placebo-controlled Clinical Trial
Primary Purpose: To evaluate whether Rajahpravartini Vati, an Ayurvedic formulation, is more effective than placebo in reducing the severity of primary dysmenorrhea in adolescent and young females aged 12-24 years.
Study Hypothesis: Rajahpravartini Vati is superior to placebo in reducing the severity of primary dysmenorrhea among adolescent and young females.
Study Design: This is a Phase III, randomized, double-blind, placebo-controlled clinical trial with 1:1 allocation ratio, to be conducted at the Regional Ayurveda Research Institute, Itanagar, Arunachal Pradesh.
Sample Size: 100 participants (50 in each group)
Primary Outcome: Change in severity of primary dysmenorrhea assessed using the WaLIDD (Working ability, Location, Intensity, Days of pain, Dysmenorrhea) score measured at baseline and after 1st, 2nd, 3rd, and 4th menstrual cycles.
Treatment Duration: RPV or placebo tablets (500mg twice daily) administered from 3 days before expected menstruation until 3 days after onset of bleeding, for 3 consecutive menstrual cycles, with one follow-up cycle.
Rationale: Previous studies on RPV for dysmenorrhea had methodological limitations. This robust double-blind, placebo-controlled trial aims to provide high-quality evidence for RPV’s efficacy in managing primary dysmenorrhea, potentially offering an effective Ayurvedic alternative for this common condition affecting young women’s quality of life.
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
- 12.00 Year(s) 至 24.00 Year(s)（—）
- 性别
- Female
入选标准
- •Menstruating females aged between 12 to 24 years.
- •Females who has never given birth to a live child (Nulliparous).
- •Females who has completed at least 1 year from the date of menarche.
- •Females with self-reported history of pain associated with menstruation for at least 3 out of last 6 menstrual cycles.
- •Females with the history of regular menstrual cycles (equal or less than 9 days variation between shortest & longest cycle) of 24 to 38 days length with bleeding duration of equal or less than 8 days & normal flow during last 3 cycles.
- •Females willing to participate in the study and agreeing to provide written informed assent and/or consent (as applicable) for participation in the study for next 5 months.
排除标准
- •Females with known/pre-diagnosed/having the history of (during the past 6 months) Gynaecological or pelvic pathologies, e.g. Uterine fibroids, gynecological malignancy, female hormonal disorders, PCOD, endometriosis, pelvic inflammatory disease, metrorrhagia, menorrhagia, leucorrhoea, gynaecological surgery, etc.
- •Females with known/pre-diagnosed/having the history of (during the past 6 months) systemic disorder likely to impact the menstrual physiology, e.g. Thyroid dysfunction, mental disorder, and moderate anaemia (Hb less than 10 gm percent), etc.
- •Females with known/pre-diagnosed/having the history of (during the past 6 months) Hypertension and diabetes mellitus.
- •Females with known/pre-diagnosed/having the history of (during the past 6 months).
- •Hepatic impairment defined as raised serum SGOT, SGPT, and total bilirubin more than 2 times of upper normal limits.
- •Females with known/pre-diagnosed/having the history of (during the past 6 months) Renal impairment defined as serum creatinine above the normal limit.
- •Females diagnosed with any of the above conditions during screening laboratory test by Serum SGOT, SGPT, Total-Direct-Indirect Bilirubin, Creatinine, FBS, Serum TSH, Hb percentage, & clinical assessment.
- •Females suffering with persistent pelvic pain throughout the menstrual cycle.
- •Females with pre-diagnosed concurrent neurological, pulmonary, endocrine, or unstable cardio-vascular disease.
- •Females currently using or having the history of using any intrauterine device, and/or taking oral contraceptive pills during last 3 cycles.
- •Females planning to conceive within the next 6 months.
- •Females on prolonged medication for any other medical condition.
结局指标
主要结局
Change in severity of primary dysmenorrhoea assessed by change in ‘WaLIDD’ score.
时间窗: At baseline, 1st, 2nd, 3rd, and 4th cycle.
次要结局
- Change in duration and intensity of pain (12 hourly) associated with primary dysmenorrhoea assessed by change in ‘VAS’ score.(At baseline, 1st, 2nd, 3rd, and 4th cycle.)
- Change in frequency of oral Antispasmodic use.(At the end of 4th cycle.)
- Change in psychosomatic status assessed by the change in ‘Moos Menstrual Distress Questionnaire’ score.(At baseline, 3rd & 4th cycle.)
- Change in perceived stress level assessed by the change in ‘Perceived Stress Scale (10 Items)’ score.(At baseline, 3rd & 4th cycle.)
研究者
Arvind Kumar
CCRAS-RARI, Itanagar, Arunachal Pradesh