CTRI/2024/04/065706招募中4 期
Effect of Ashwagandha (Withania Somnifera) Root Extract on the Improvement of Health in Post Menopausal Women: A Prospective, Randomized, Double Blinded, Placebo-Controlled Clinical Trial
Simran Obhrai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone mass density using DXA
研究概览
简要总结
This prospective, randomized, double-blinded, placebo-controlled clinical trial aims to assess the effect of Ashwagandha root extract on postmenopausal women’s health. Participants will undergo baseline assessments, including DEXA scans, liver function tests, and serum calcium levels, before randomization to treatment or placebo. They will then consume 600mg or placebo tablets daily for three months, with monthly liver function tests to monitor safety. Changes in various health parameters will be evaluated pre- and post-intervention, with statistical analysis conducted on an intention-to-treat basis.
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 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Willing and able to give written informed consent for participation in the study
- •Age range 45-65 years
- •Post Menopausal status (defined by >1 yr since last menstrual period)
- •Ambulatory
- •Body mass Index (BMI) ≥18 and ≤32 kg/m2 at screening
- •Commitment to not use calcium or vitamin D supplementation that may influence the study outcome
- •Ability to understand and comply with the requirements of the study.
排除标准
- •Pre-menopausal or perimenopausal status or surgical menopause
- •History of chronic immunological or bone-related disorders, kidney disease, cardiovascular disease
- •History of bariatric surgery or other forms of malabsorption (including documented celiac disease or chronic diarrhoea)
- •Alcohol abuse
- •History of use of oral supplement products containing ashwagandha or Calcium, Vitamin D (more than once per week) within 4 weeks prior to baseline
- •Current use (within the past 8 weeks) of any medication with known influences on the immune or skeletal system (e.g. immune modulation therapy, systemic glucocorticoids, systemic steroid hormones)
- •Current or past use (within 1 year of starting the study) of denosumab, teriparatide, raloxifene, hormone replacement therapy, calcitonin, or any other anti-resorptive agent used for the prevention and treatment of osteoporosis.
- •Smoking or use of nicotine-containing products during the last 6 months
- •Uncontrolled thyroid disease (abnormal blood thyroid stimulating hormone level within the last 12 months and/or changing dose of thyroid replacement therapy within the last 12 months).
结局指标
主要结局
Bone mass density using DXA
时间窗: 0 Month, 2 Months
次要结局
- Sleep Quality, General Wellness, liver function test(before (Day 0) and After (Day 60-70))
研究者
Simran Obhrai
MYAS-GNDU Department of Sports Sciences and Medicine
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Effectiveness of ashwagandha in pregnant womenCTRI/2025/01/079238Ixoreal Biomed Private Limited70
招募中
2 期
A clinical trial of Aswagandha and Shilajit in male sexual dysfunction due to mild to moderate stress disordersCTRI/2024/12/078369Sakti Naturals Pvt. Ltd90
已完成
Phase 3 4
Clinical trial on muscle endurance in healthy male volunteersCTRI/2025/03/083139Ingex Botanicals Private Limited60
招募中
3 期
TO COMPARE THE EFFICACY OF ASHWAGANDHADYA GHRITA PANA AND NASYA ALONG WITH RASNAPANCHAK KWATHA AND GUGGULU VATI IN THE MANAGEMENT OF CERVICAL SPONDYLOSISCTRI/2025/03/083350NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY DEEMED TO BE UNIVESRITY JAIPUR40
尚未招募
2/3 期
To check the effectiveness of Vachai Choorna in Karshya, (Malnutrition)- A randomized controlled clinical study.CTRI/2024/08/072348Dr Pawar Anuja Samindar40