Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 39
- 主要终点
- The Premenstrual Symptoms Screening Tool (PSST)
研究概览
简要总结
Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome (PMS) affecting up to 8% of reproductive age women. It is characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and leads to negative impact on the psychosocial functioning of affected individuals.
Selective serotonin reuptake inhibitors are usually used to treat PMDD but they have several side effects so it is important to use complementary treatment such as tryptophan-rich diet and acupuncture for women with PMDD . The purpose of the current study is to determine the combined effect of tryptophan-rich diet and acupuncture on depression related to premenstrual dysphoric disorder
详细描述
This study will be conducted on 39 participants suffering from premenstrual dysphoric disorder (PMDD). They will be recruited from Horus University, New Damietta, Egypt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All females will be clinically diagnosed with premenstrual dysphoric disorder (PMDD) as confirmed and referred from the gynaecologist.
- •All females will be firstly assessed by Hamilton Depression rating scale (HDRS) for two months to confirm depression related to PMDD before participating in the study.
- •Their ages will be ranged from 20 to 30 years.
- •Their BMI will be ranged from 20 to 25 kg/m.
- •Being virgin.
- •Having regular menstruation for the last 6 months (every 28- 35 days with no intermittent bleeding).
- •All females have a sedentary lifestyle.
- •Voluntary acceptance of participation in the study
排除标准
- •Using hormonal contraception (such as oral contraceptives and injections).
- •Menstrual irregularity.
- •Using diuretics or psychiatric medications.
- •Using chronic non-steroidal anti-inflammatory drugs.
- •Pre-diagnosed with any other psychological problems not related to PMDD.
- •Follow any exercise programs.
结局指标
主要结局
The Premenstrual Symptoms Screening Tool (PSST)
时间窗: Up to 2 months
It is a validated, simple, user-friendly screening tool to identify women who suffer from severe Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD). It reflects and 'translates' categorical Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria into a rating scale with degrees of severity (Not at all, mild, moderate, severe). The scoring will be as follows: the following criteria must be present for a diagnosis of PMDD: * At least one of #1, #2, #3, and #4 is severe. * In addition at least four of #1 - #14 are moderate to severe. * At least one of A, B, C, D and E is severe.
Hamilton Depression Rating Scale (HDRS)
时间窗: Up to 2 months
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. HRSD provides a reliable and valid assessment of depression. Method for scoring varies by version. For the HDRS17, a score of 0 - 9 is generally accepted to be within the normal range, 10 - 13 mild, 14-17 mild to moderate and \>17 moderate to severe
次要结局
- Quality of Life Enjoyment and Satisfaction Questionnaire - short form(Up to months 2)
研究者
Nahla Mohamed Ashour Gebril
Demonstrator at Physical Therapy department of Women's Health , Faculty of Physical Therapy, Horus University
Cairo University