Effect of selective acupuncture points on pain in patients with primary Dysmenorrhea - A Randomized controlled trail
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of visual analogue scale,
研究概览
简要总结
Primary Dysmenorrhea is defined as cramping pain during menstruation without any identifiable pathology. It is a common gynecological complaint that can affect as many as 50% of women, 10% of these women suffer severely enough to render them incapacitated for one to three days in each menstrual cycle, Acupuncture, derived from China, is a therapeutic modality using the insertion of fine needles and manipulating them with manual, electrical, or other forms of stimulation. According to traditional and modern diagnosis, several points help to inhibit the inflammatory markers production leading to a reduced menstrual cramps. Penetrating Vessel is involved in all cases of Blood stasis in gynecological disorders. Kidneys as it originates in that area essence and it distributes Essence all over the body. Baseline assessments will be done before the onset of the study on the first day of menstruation. The post-assessments will be done after the completion of the 3 months intervention, on the first day of menstruation in the fourth month of the study. This Randomized control study will be conducted among 60 participants aged between 18 to 24 years randomly recruited from the residential college. Female participants satisfying the inclusion and exclusion criteria will be included in the study. The information about the study will be instructed to the subjects. After obtaining the written consent, the procedure of study will be carried out in the duration of 3 months. All the eligible subjects will be randomly divided into 2 groups. The study group will undergo needling (P6, SP4, KI14, LIV3) thrice a week followed for 3 months . While the control group will be given sham acupuncture for 20 minutes during the same time followed by 3 months . The study will assess Visual Analogue Scale (VAS), Menstrual Symptom Questionnaire (MSQ) and C-reactive protein before and after the intervention of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 28.00 Year(s)(—)
- 性别
- Female
入选标准
- •Females under age group of 18 to 28 years having dysmenorrhea since menarche and willing to give consent.
排除标准
- •Patients having underlying malignancy, infection or any underlying pathological condition.
- •needle phobia pregnant and lactating women.
- •patient who are not mentally stable.
结局指标
主要结局
Assessment of visual analogue scale,
时间窗: Baseline & 13th week
Menstrual symptom questionnaire
时间窗: Baseline & 13th week
次要结局
- Assessment of variation in C-Reactive protein level(Baseline & 13th week)
研究者
Dr R JENIE
International Institute of Yoga and Naturopathy Medical Sciences
