Clinical efficacy of Ashokarishtam, AYUSH SR, and Praval Pishti in the management of Menopausal syndrome (Rajonivrittti Lakshan) : A Prospective Randomized Open Label Standard Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in Menopausal symptoms using menopause Rating scale (MRS)
研究概览
简要总结
Menopause is mainly characterized by permanent cessation of menstruation for more than 12 months. Hormone Replacement Therapy (HRT) prescribed by Modern science carries potential risks such as breast cancer endometrial cancer ovarian cancer stroke etc Hence needs careful assessment and evaluation of each individual. In Ayurveda, menopause is considered under Jara vyadhi. There is a potential scope for Rasayan therapy in managing menopausal syndrome. Preferably vata pacifying rasayan drugs should be used in menopause*.* These agents act at the level of rasa by improving the nutritional value of *poshakrasa (*nutritive fluids),which helps to obtain the best quality of body tissues (dhatus). Therefore, among various rasayan drugs Ashokarishtam, Ayush SR, and Praval Pishti were selected along with standard control in the management of Menopausal syndrome (Rajonivrittti Lakshan. Hence the study aims to assess the clinical efficacy of Ashokarishtam, Ayush SR, and Praval Pishti in the management of Menopausal syndrome (Rajonivrittti Lakshan)
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
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient with with amenorrhea of more than or equal to 12 months ii.
- •Kuperman menopausal index score Of ore than or equal to 15 iii.
- •Willing to participate in the study.
排除标准
- •Patients with age less 40 years and more 55 years
- •Level of FSH less than 25.8 IU/L
- •Endometrial thickness more than 5mm
- •Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- •creatinine more than 1.2mg/dl)
- •uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease
- •Patients with endocrine disorders (hypothyroidism Hyperthyroidism hyperparathyroidism Untreated Cushing‘s syndrome
- •Patients with poorly controlled Hypertension ( more than 160 / 100 mm Hg)
- •Patients who are consuming any drug which is known to affect bone metabolism such as SERMs, bisphosphonates, calcitonin, Vit D (more than 60,000 units) and corticosteroids.
- •Patients with Diabetes Mellitus, Rheumatoid arthritis, Coronary Heart disease
- •Alcoholics and/or drug abusers for more than 3 months, methotrexate anti-convulsants diuretics etc
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •H/o hypersensitivity to any of the trial drugs or their ingredients
- •Patients who have completed participation in any other clinical trial during the past six months.Any other condition that the investigator thinks may jeopardise the study.
结局指标
主要结局
Changes in Menopausal symptoms using menopause Rating scale (MRS)
时间窗: at base line, 14th day, 28th day, 42nd 56th , 70th day ,84th day and 112th day
次要结局
- Changes in Quality of Life index (QOL) using the MENQOL questionnaire & Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) Questionnaire(Changes in hematological & biological parameters viz CBC LFT lipid profile KFT serum calcium FSH LH Estradiol)
研究者
Dr Monika
reserach officer Ayu