Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Menopause Rating Scale (MRS)
研究概览
简要总结
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.
详细描述
To qualify for the study, participants must be menopausal women aged 45 to 65 years with intact uterus and ovaries. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days. Women with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing.
It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 18-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Sr. Estradiol, FSH, LH, Testosterone levels. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menopausal women aged 45 to 65 years with intact uterus and ovaries.
- •Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
- •Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- •Body mass index 18-35 kg/m2
- •Subject who has given written informed consent to participate in the study and understand the nature of the study
- •Able to read and write in English or any other vernacular language
- •No plan to commence new treatments over the study period.
- •Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •Participants taking any form of herbal extract in the last 3 months before study entry.
- •Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •Participants with Present active medical, surgical, and gynaecological problems.
- •Participants with a history of alcohol, tobacco dependence, or any substance abuse
- •Participants who had undergone bilateral ovariectomy
- •Participants with history of breast or cervical carcinoma
- •Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- •Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
- •Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Participants with evidence of uncooperative attitude, including poor compliance.
- •Participants with inability to attend follow-up visit
- •Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- •Patients with known hypersensitivity to Ashwagandha.
- •Patients who had participated in other clinical trials during the previous 3 months.
- •Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol
研究组 & 干预措施
Shatavari
One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.
干预措施: Shatavari extract (Dietary Supplement)
Shatavari + Ashwagandha
One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.
干预措施: Shatavari + Ashwagandha extract (Dietary Supplement)
Placebo
One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Menopause Rating Scale (MRS)
时间窗: MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.
次要结局
- Perceived Stress Scale (PSS)(PSS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).)
- Menopause-Specific Quality of Life Questionnaire (MENQOL)(MENQOL assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).)
- Profile of Mood States (POMS, abbreviated version)(POMS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).)
- Serum Hormones(Blood samples for Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8))