CTRI/2025/12/099019招募中Phase 3 4
A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Cyperus rotundus extract (Cirpusins®) for weight management and Post Menopausal Syndrome (PMS).
SamiSabinsa Group Limited2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年1月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
研究概览
简要总结
this clinical study a randomized double-blind placebo controlled trial to evaluate the efficacy and safety of Cyperus rotundus extract Cirpusins® for weight management and post menopausal syndrome PMS.
This study aims to provide robust evidence on the potential benefits and safety of Cyperus rotundus in weight management for postmenopausal women
Secondary Endpoints includes
Mean change in Lipid profile from the beginning till the end of the study.
Mean change in Serum hormone levels FSH LH Estradiol Progesterone Testosterone from Day 1 to Day 91.
Incidence of any AE SAE during the study period.
·
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
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants must provide a voluntarily written and signed ICF to be screened & enrolled in the study.
- •Participant must be a clinically confirmed post-menopausal women in the age group of 45 to 65 years both inclusive.
- •Must be overweight obese with a body mass index BMI between 25 to 34.9 kg m2 both inclusive.
- •Any Case of self-reported post-menopausal symptoms for the past 3 months like • Vasomotor symptoms (hot flashes night sweats sweating.
- •• Psychosocial (anxiety depression irritability loneliness • Physical (flatulence or gas pains aching in muscle or joints insomnia decrease in physical strength weight gain frequent urination.
- •• Sexual (mood changes, vaginal atrophy
- •Participants with MRS severity range from moderate 9to15 to severe
- •Individuals must be in good health with controlled diabetes and hypertension with medications, but without thyroid disease.
- •Participants must be able to consume the investigational product as per the protocol throughout the study period.
- •Have normal vital signs or within clinically acceptable range as considered by the Principal Investigator at the time of screening and follow-up visits.
- •Must not have taken any treatment for PMS and agree to refrain from any other treatments for post-menopause symptoms during the study period.
- •Willing to abide by the protocol and all study related procedures from the beginning till the end of the study.
排除标准
- •Induced menopause through surgery such as bilateral oophorectomy or salpingooophorectomy chemotherapy radiation or drugs.
- •Individuals who had undergone a partial or total hysterectomy.
- •Use of any treatment for post-menopausal symptoms.
- •Have a known sensitivity, intolerability or allergy to any of the study products or their excipients.
- •Have a positive medical history of heart disease, renal disease hepatic impairment or active systemic infection.
- •Have uncontrolled high blood pressure greater than160 mmHg systolic or more than or equal to110 mmHg diastolic or thyroid disease despite taking regular medication for the last three months at the time of screening and enrolment.
- •Have Type I or uncontrolled Type 2 diabetes HbA1c morethan 9.
- •Use of any weight loss medication, special diets or supplements.
- •History of cancer.
研究者
Dr Mahalakshmi Pendurthi
Medwell Multi Speciality Hospital
研究点 (2)
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