CTRI/2024/07/070216尚未招募2 期
Clinical study to evaluate effect of iCare plus in management of health during menopause period. A quality-of-life clinical study
IndusViva Healthsciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月29日最近更新:
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
- Changes in Menopause Rating scale, hot flushes, night sweats, anxiety, stress, joint pain and other symptoms of menopause
研究概览
简要总结
The main objective of the trial is to evaluate benefit of IP in Reduction in Hot flashes, Reduction in Night sweats, coping up with anxiety & stress, Reduced Muscle & Joint pains, Feel Energetic, help weight management, Overcoming Vaginal Dryness, FSH & Estrogen (estradiol), Luteinizing hormone, through MENQOL and MRS QOL questionnaire to evaluate general health and wellbeing during menopause and to assess the safety of the iCare+.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women aged over 40 2.Subjects going through menopause 3.Subjects who voluntarily agree to participate in this clinical trial in writing 4.Subjects who have more than 2 symptoms according to menopause care QOL.
排除标准
- •1.Subjects with hysterectomy or oophorectomy 2.PCOD or similar condition 3.Subjects who are on steroids for certain health conditions 4.Subjects who refuse to sign the informed consent form.
结局指标
主要结局
Changes in Menopause Rating scale, hot flushes, night sweats, anxiety, stress, joint pain and other symptoms of menopause
时间窗: baseline, 3rd month and 6th month.
次要结局
- changes in lab values for estrogen, FSH and LH. Also, safety of IP(baseline, 3rd month and 6th month.)
研究者
Dr Hema Divakar
Divakars Speciality Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)NCT07413601Cancer Institute and Hospital, Chinese Academy of Medical Sciences78
尚未招募
Unknown
safety & Efficacy of Hairsync H plus in Hair Growth and hairfallCTRI/2025/08/092717Hairsync Solution Private Limited60
尚未招募
不适用
Effect of Heat therapy and Exercises with medicines in Chronic low back pain.CTRI/2025/08/092334Pranav Purohit66
尚未招募
不适用
A Randomized Control Trial To Study The Effect Of Warm Footbath And Aromatherapy On The Level Of The Stress, Sleep Quality And Fatigue Among Patients With Cancer Undergoing Chemotherapy And Radiation Therapy In R.I.M.S. RanchiCTRI/2025/07/091666Rajendra Institute of Medical Sciences75
尚未招募
不适用
Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled TrialAllergic RhinitisNCT07269509Renmin Hospital of Wuhan University276