Efficacy of Badranjboya in Postmenopausal Syndrome: A Randomized Placebo-Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Modified Kupperman Index questionnaire
研究概览
简要总结
The Unani system of medicine there is no precise description of menopause, it can be discussed under amenorrhea and associated with age of the natural end of menstruation, which is an enrichment to the Unani medical system. More than 90 percent of women could have serious short-term and long-term menopausal syndromes, which include urogenital (vaginal dryness, sexual dysfunction), psychological (stress, anxiety, depression), and vasomotor (hot flashes, sweating) symptoms. Menopausal symptoms have the potential to cause serious mental disease and a low quality of life. One of the Unani medicines isBadranjboya (Melissa officinalisL*.*) in postmenopausal women is effective as it possessesexhilarant,cardiotonic, concoctive, resolvent, carminative, stimulant, and sedative properties.Furthermore, pharmacologically, ithas phytoestrogens, antioxidant, anxiolytic, anti-diabetic, antidepressant, cardioprotective, neuroprotective, anti-inflammatory, and antithyroidal activities.To date, none of the studies has determined the efficacy and safety of Badranjboyain postmenopausal syndrome. Hence, there is a need to conduct a clinical trial to determine the efficacy and safety of Badranjboya in postmenopausal syndrome. The hypothesis of the study would Badranjboya will be effective in post menopausal sydrome at post intervention. Diagnosed cases will be randomly allocated either to the test or control group and written informed consent will be obtained. Participants, PG scholars, and analysts will be blinded to the study. Orally, in the test group, Badranjboyafive grams daily will be administered for 8 weeks. In the control group, a placebo will be given. Any adverse reaction to drugs such as abdominal pain, urticaria, itching, nausea, vomiting, headache, fatigue and other unsuspected side effects will be documented. The appropriate tests will be applied to analyse the data. Descriptive statistical analysis will be used in the study. Results on continuous measurements will be presented in mean (SD) and results on the categorical measurements will be presented in number with a 5 percent level of significance and 95 percent confidence interval
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •All postmenopausal women (at least 1 year without menstrual cycle) with any postmenopausal symptoms as per Modified Kupperman Index scale (MKI) greater than or equal to 7 Women with Pittsburgh Sleep Quality Index score greater than or equal to 5 Women with psychological menopausal symptoms as per Depression, Anxiety and Stress Scale (DASS-21 scale).
- •All postmenopausal women with follicle stimulating hormone (FSH) greater than 30 IU/ml.
排除标准
- •Women with undiagnosed vaginal bleeding, surgical menopause (bilateral oophorectomy) and malignancies.
- •Use of hormone therapy or oral contraceptives within two months.
- •Women with co-morbidities such as uncontrolled hypertension (Stage 2 hypertension more than 140/90 mmHg), uncontrolled diabetes mellitus (FBS more than 130mg/dl or PPBS more than 180 mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00 percent), uncontrolled hypothyroid.
- •Women with extremely severe psychological menopausal symptoms with DASS-21 scores for Depression more than 28, Anxiety more than 20 and Stress more than
- •Women with obstructive sleep apnea, restless leg syndrome, parasomnia, substances use such as alcohol or on sleeping pills.
- •Women with diagnosed psychiatric diseases.
结局指标
主要结局
Change in Modified Kupperman Index questionnaire
时间窗: 4, 8, 12 and 16 weeks
次要结局
- Change in DASS-21, PSQI, & Palpitation as per MKI score.
研究者
Saman Fatma
National Institute of Unani Medicine
